Trial Title:
A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
NCT ID:
NCT05761171
Condition:
Recurrent Acute Leukemia of Ambiguous Lineage
Recurrent Acute Lymphoblastic Leukemia
Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage
Recurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged
Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia
Recurrent Mixed Phenotype Acute Leukemia
Refractory Acute Leukemia of Ambiguous Lineage
Refractory Acute Lymphoblastic Leukemia
Refractory Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage
Refractory Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged
Refractory Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia
Refractory Mixed Phenotype Acute Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Recurrence
Acute Disease
Cytarabine
Prednisone
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Cortisone
Methotrexate
Fludarabine
Fludarabine phosphate
Vincristine
Asparaginase
Prednisolone hemisuccinate
Prednisolone phosphate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood and CSF samples
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Arm group label:
Regimen B (revumenib, FLA)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Marrow Aspiration
Description:
Undergo bone marrow aspiration
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Arm group label:
Regimen B (revumenib, FLA)
Intervention type:
Drug
Intervention name:
Calaspargase Pegol
Description:
Given IV
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Other name:
Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl)
Other name:
Asparlas
Other name:
Calaspargase Pegol-mknl
Other name:
EZN-2285
Other name:
SC-PEG E. Coli L-Asparaginase
Other name:
Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Given IV and IT
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Arm group label:
Regimen B (revumenib, FLA)
Other name:
.beta.-Cytosine arabinoside
Other name:
1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
Other name:
1-.beta.-D-Arabinofuranosylcytosine
Other name:
1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
Other name:
1-Beta-D-arabinofuranosylcytosine
Other name:
1.beta.-D-Arabinofuranosylcytosine
Other name:
2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
Other name:
2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
Other name:
Alexan
Other name:
Ara-C
Other name:
ARA-cell
Other name:
Arabine
Other name:
Arabinofuranosylcytosine
Other name:
Arabinosylcytosine
Other name:
Aracytidine
Other name:
Aracytin
Other name:
Aracytine
Other name:
Beta-Cytosine Arabinoside
Other name:
CHX-3311
Other name:
Cytarabinum
Other name:
Cytarbel
Other name:
Cytosar
Other name:
Cytosine Arabinoside
Other name:
Cytosine-.beta.-arabinoside
Other name:
Cytosine-beta-arabinoside
Other name:
Erpalfa
Other name:
Starasid
Other name:
Tarabine PFS
Other name:
U 19920
Other name:
U-19920
Other name:
Udicil
Other name:
WR-28453
Intervention type:
Procedure
Intervention name:
Echocardiography
Description:
Undergo ECHO
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Arm group label:
Regimen B (revumenib, FLA)
Other name:
EC
Intervention type:
Drug
Intervention name:
Fludarabine Phosphate
Description:
Given IV
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Arm group label:
Regimen B (revumenib, FLA)
Other name:
2-F-ara-AMP
Other name:
9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-
Other name:
Beneflur
Other name:
Fludara
Other name:
SH T 586
Intervention type:
Drug
Intervention name:
Hydrocortisone Sodium Succinate
Description:
Given IT
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Arm group label:
Regimen B (revumenib, FLA)
Other name:
(11beta)-21-(3-Carboxy-1-oxopropyl)-11,17-dihydroxypregn-4-ene-3,20-dione, Monosodium Salt
Other name:
A-Hydrocort
Other name:
Buccalsone
Other name:
Corlan
Other name:
Cortisol Sodium Succinate
Other name:
Cortop
Other name:
Efcortelan
Other name:
Emergent-EZ
Other name:
Flebocortid
Other name:
Hidroc Clora
Other name:
Hycorace
Other name:
Hydro-Adreson
Other name:
Hydrocort
Other name:
Hydrocortisone 21-Sodium Succinate
Other name:
Hydrocortisone Na Succinate
Other name:
Kinogen
Other name:
Nordicort
Other name:
Nositrol
Other name:
Sinsurrene
Other name:
Sodium hydrocortisone succinate
Other name:
Solu-Cortef
Other name:
Solu-Glyc
Intervention type:
Procedure
Intervention name:
Lumbar Puncture
Description:
Undergo lumbar puncture
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Arm group label:
Regimen B (revumenib, FLA)
Other name:
LP
Other name:
Spinal Tap
Intervention type:
Drug
Intervention name:
Methotrexate
Description:
Given IT
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Arm group label:
Regimen B (revumenib, FLA)
Other name:
Abitrexate
Other name:
Alpha-Methopterin
Other name:
Amethopterin
Other name:
Brimexate
Other name:
CL 14377
Other name:
CL-14377
Other name:
Emtexate
Other name:
Emthexat
Other name:
Emthexate
Other name:
Farmitrexat
Other name:
Fauldexato
Other name:
Folex
Other name:
Folex PFS
Other name:
Lantarel
Other name:
Ledertrexate
Other name:
Lumexon
Other name:
Maxtrex
Other name:
Medsatrexate
Other name:
Metex
Other name:
Methoblastin
Other name:
Methotrexate LPF
Other name:
Methotrexate Methylaminopterin
Other name:
Methotrexatum
Other name:
Metotrexato
Other name:
Metrotex
Other name:
Mexate
Other name:
Mexate-AQ
Other name:
MTX
Other name:
Novatrex
Other name:
Rheumatrex
Other name:
Texate
Other name:
Tremetex
Other name:
Trexeron
Other name:
Trixilem
Other name:
WR-19039
Intervention type:
Procedure
Intervention name:
Multigated Acquisition Scan
Description:
Undergo MUGA scan
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Arm group label:
Regimen B (revumenib, FLA)
Other name:
Blood Pool Scan
Other name:
Equilibrium Radionuclide Angiography
Other name:
Gated Blood Pool Imaging
Other name:
Gated Heart Pool Scan
Other name:
MUGA
Other name:
MUGA Scan
Other name:
Multi-Gated Acquisition Scan
Other name:
Radionuclide Ventriculogram Scan
Other name:
Radionuclide Ventriculography
Other name:
RNVG
Other name:
SYMA Scanning
Other name:
Synchronized Multigated Acquisition Scanning
Intervention type:
Drug
Intervention name:
Prednisolone
Description:
Given PO or via NG, NJ, ND or G-tube
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Other name:
(11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
Other name:
.delta.1-Hydrocortisone
Other name:
Adnisolone
Other name:
Aprednislon
Other name:
Capsoid
Other name:
Cortalone
Other name:
Cortisolone
Other name:
Dacortin H
Other name:
Decaprednil
Other name:
Decortin H
Other name:
Delta(1)Hydrocortisone
Other name:
Delta- Cortef
Other name:
Delta-Cortef
Other name:
Delta-Diona
Other name:
Delta-F
Other name:
Delta-Phoricol
Other name:
Delta1-dehydro-hydrocortisone
Other name:
Deltacortril
Other name:
Deltahydrocortisone
Other name:
Deltasolone
Other name:
Deltidrosol
Other name:
Dhasolone
Other name:
Di-Adreson-F
Other name:
Dontisolon D
Other name:
Estilsona
Other name:
Fisopred
Other name:
Frisolona
Other name:
Gupisone
Other name:
Hostacortin H
Other name:
Hydeltra
Other name:
Hydeltrasol
Other name:
Klismacort
Other name:
Kuhlprednon
Other name:
Lenisolone
Other name:
Lepi-Cortinolo
Other name:
Linola-H N
Other name:
Linola-H-Fett N
Other name:
Longiprednil
Other name:
Metacortandralone
Other name:
Meti Derm
Other name:
Meticortelone
Other name:
Opredsone
Other name:
Panafcortelone
Other name:
Precortisyl
Other name:
Pred-Clysma
Other name:
Predeltilone
Other name:
Predni-Coelin
Other name:
Predni-Helvacort
Other name:
Prednicortelone
Other name:
Prednisolonum
Other name:
Prelone
Other name:
Prenilone
Other name:
Sterane
Intervention type:
Drug
Intervention name:
Prednisone
Description:
Given PO or via NG, NJ, ND or G-tube
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Other name:
.delta.1-Cortisone
Other name:
1, 2-Dehydrocortisone
Other name:
Adasone
Other name:
Cortancyl
Other name:
Dacortin
Other name:
DeCortin
Other name:
Decortisyl
Other name:
Decorton
Other name:
Delta 1-Cortisone
Other name:
Delta-Dome
Other name:
Deltacortene
Other name:
Deltacortisone
Other name:
Deltadehydrocortisone
Other name:
Deltasone
Other name:
Deltison
Other name:
Deltra
Other name:
Econosone
Other name:
Lisacort
Other name:
Meprosona-F
Other name:
Metacortandracin
Other name:
Meticorten
Other name:
Ofisolona
Other name:
Orasone
Other name:
Panafcort
Other name:
Panasol-S
Other name:
Paracort
Other name:
Perrigo Prednisone
Other name:
PRED
Other name:
Predicor
Other name:
Predicorten
Other name:
Prednicen-M
Other name:
Prednicort
Other name:
Prednidib
Other name:
Prednilonga
Other name:
Predniment
Other name:
Prednisone Intensol
Other name:
Prednisonum
Other name:
Prednitone
Other name:
Promifen
Other name:
Rayos
Other name:
Servisone
Other name:
SK-Prednisone
Intervention type:
Drug
Intervention name:
Revumenib
Description:
Given PO or via NG, NJ, ND or G-tube
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Arm group label:
Regimen B (revumenib, FLA)
Other name:
Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613
Other name:
Menin-MLL Inhibitor SNDX-5613
Other name:
Menin-MLL Interaction Inhibitor SNDX-5613
Other name:
SNDX 5613
Other name:
SNDX-5613
Other name:
SNDX5613
Intervention type:
Drug
Intervention name:
Vincristine Sulfate
Description:
Given IV
Arm group label:
Regimen A (revumenib, 3-drug re-induction, FLA)
Other name:
Kyocristine
Other name:
Leurocristine Sulfate
Other name:
Leurocristine, sulfate
Other name:
Oncovin
Other name:
Vincasar
Other name:
Vincosid
Other name:
Vincrex
Other name:
Vincristine, sulfate
Summary:
This phase II trial tests the safety and best dose of revumenib in combination with
chemotherapy, and evaluates whether this treatment improves the outcome in infants and
young children who have leukemia that has come back (relapsed) or does not respond to
treatment (refractory) and is associated with a KMT2A (MLL) gene rearrangement (KMT2A-R).
Leukemia is a cancer of the white blood cells, where too many underdeveloped (abnormal)
white blood cells, called "blasts", are found in the bone marrow, which is the soft,
spongy center of the bones that produces the three major blood cells: white blood cells
to fight infection; red blood cells that carry oxygen; and platelets that help blood clot
and stop bleeding. The blasts crowd out the normal blood cells in the bone marrow and
spread to the blood. They can also spread to the brain, spinal cord, and/or other organs
of the body. The leukemia cells of some children have a genetic change in which a gene
(KMT2A) is broken and combined with other genes that typically do not interact with one
another; this is called "rearranged". This genetic rearrangement alters how other genes
are turned on or off in the cell, turning on genes that drive the development of
leukemia. Patients with KMT2A rearrangement have higher risk for cancer coming back after
treatment. Revumenib is an oral medicine that directly targets the changes that occur in
a cell with a KMT2A rearrangement and has been shown to specifically kill these leukemia
cells in preclinical laboratory settings and in animals. Drugs used in chemotherapy, such
as vincristine, prednisone, asparaginase, fludarabine and cytarabine work in different
ways to stop the growth of cancer cells, either by killing the cells, by stopping them
from dividing, or by stopping them from spreading. This trial is being done to find out
if the combination of revumenib and chemotherapy would be safe and/or effective in
treating infants and young children with relapsed or refractory KMT2A-R leukemia.
Detailed description:
PRIMARY OBJECTIVES:
I. To determine the recommended phase 2 dose (RP2D) of revumenib administered in
combination with chemotherapy in patients with relapsed or refractory (R/R)
KMT2A-rearranged (KMT2A-R) acute lymphoblastic leukemia (ALL).
II. To estimate the minimal residual disease (MRD) negative remission rate of patients
with R/R infant KMT2A-R ALL treated with revumenib in combination with chemotherapy.
SECONDARY OBJECTIVES:
I. To characterize the pharmacokinetics (PK) of revumenib administered with chemotherapy
in patients with R/R infant KMT2A-R ALL.
II. To estimate the 18-month event-free survival (EFS) of patients with R/R infant
KMT2A-R ALL treated with revumenib in combination with chemotherapy.
III. To estimate 18-month overall survival (OS) of patients with R/R infant KMT2A-R ALL
treated with revumenib in combination with chemotherapy.
IV. To characterize the tolerability of revumenib given as monotherapy in patients with
R/R infant KMT2A-R ALL.
EXPLORATORY OBJECTIVE:
I. To assess the biologic activity of revumenib administered with chemotherapy in
patients with R/R KMT2A-R ALL.
II. To estimate the MRD negative remission rate of patients with R/R non-infant KMT2A-R
ALL treated with revumenib in combination with chemotherapy.
III. To characterize the PK of calaspargase pegol-mknl and describe associated toxicities
for patients with R/R KMT2A-R ALL.
IV. To describe the anti-cancer therapies received before and after administration of
revumenib by patients with R/R KMT2A-R ALL.
OUTLINE: Patients with acute lymphoblastic leukemia (ALL), acute leukemia of ambiguous
lineage (ALAL), or mixed phenotype acute leukemia (MPAL) are assigned to 1 of 2 regimens,
by physician discretion. Patients with acute myeloid leukemia (AML) are assigned to
Regimen B.
REGIMEN A:
COMBINATION CYCLE 1: Patients receive revumenib orally (PO) or via nasogastric (NG),
nasojejunal (NJ), nasoduodenal (ND) or gastrostomy tube (G-tube) every 12 hours
continuously. Patients also receive "3-drug re-induction" consisting of vincristine
intravenously (IV) on days 1, 8, 15, and 22, prednisone or prednisolone PO or via NG, ND,
NJ, or G-tube twice daily (BID) on days 1-28, calaspargase pegol-mknl IV over 1-2 hours
on day 4, as well as methotrexate (MTX) intrathecally (IT) on days 1 and 8 then
optionally weekly, hydrocortisone IT, and cytarabine IT. Patients who have early
progressive disease may continue to Combination Cycle 2 early before fully completing
cycle 1.
COMBINATION CYCLE 2: Patients receive revumenib PO or via NG, NJ, ND, or G-tube every 12
hours continuously, "FLA" consisting of fludarabine IV over 60 minutes and high-dose
cytarabine IV over 1-3 hours on days 1-5. After completion of Combination Cycle 2,
patients who experienced early progressive disease in Combination Cycle 1 continue to
Combination Cycle 3. All other patients proceed to Monotherapy.
COMBINATION CYCLE 3: Patients receive revumenib PO or via NG, NJ, ND, or G-tube every 12
hours continuously, "FLA" as in Combination Cycle 2, MTX IT, hydrocortisone IT, and
cytarabine IT on day 0.
MONOTHERAPY: Patients receive revumenib PO or via NG, NJ, ND, or G-tube every 12 hours
continuously. Patients may also receive MTX IT, hydrocortisone IT, and cytarabine IT as
clinically indicated.
REGIMEN B:
COMBINATION CYCLES 1-2: Patients receive revumenib PO or via NG, ND, NJ, or G-tube every
12 hours continuously, "FLA" IV on days 1-5, MTX IT, hydrocortisone IT, and cytarabine IT
on day 0 and optionally on days 8, 15, and 22 of each cycle. Cycles repeat every 28 days
for 2 cycles.
MONOTHERAPY: Patients receive revumenib PO or via NG, ND, NJ, or G-tube every 12 hours
continuously. Treatment repeats every 28 days for up to 12 cycles on study in the absence
of disease progression or unacceptable toxicity. Patients may also receive MTX IT,
hydrocortisone IT, and cytarabine IT on days 0, 8, 15 and 22 as clinically indicated.
All patients also undergo echocardiography (ECHO) or multigated acquisition scan (MUGA),
collection of blood and cerebrospinal fluid (CSF) samples, lumbar puncture, and bone
marrow aspiration throughout the trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must be 1 month to < 6 years old at the time of study enrollment and must
have had initial diagnosis of leukemia at < 2 years old.
- Patients must have KMT2A-rearranged acute lymphoblastic leukemia (ALL), acute
leukemia of ambiguous lineage (ALAL), or mixed phenotype acute leukemia (MPAL),
which is determined to be refractory or in first marrow relapse. All patients must
undergo cytogenetics and fluorescence in situ hybridization (FISH) testing of a
relapsed/refractory blast sample at a Children's Oncology Group (COG)-approved
laboratory for KMT2A-R status determination and the presence of a KMT2A-
rearrangement must be confirmed by central review. Cytogenetics results must be
submitted for central review by Day 10 of protocol therapy, for confirmation of
KMT2A-R status. Patients enrolled with refractory disease may utilize initial
diagnostic cytogenetics for eligibility and submission for central review if testing
was performed at a COG approved laboratory. Patients will be eligible to remain on
protocol therapy if KMT2A-R is confirmed by central review. Additional methods of
assessing for KMT2A-R may be considered if FISH does not detect the rearrangement.
- Disease status at time of enrollment must be one of the following:
- First relapse (untreated): Any recurrence of marrow disease, with or without
other extramedullary sites(s), at any point after achieving remission
("remission-1", per definition below) and meeting one of the below criteria.
Patients must not have received any disease-directed therapy for the marrow
relapse prior to enrollment, other than permitted cytoreduction.
- Relapse M1: M1 morphology (< 5% blasts) + at least 2 confirmatory tests
showing >= 1% blasts (testing includes flow, cytogenetics, polymerase
chain reaction [PCR]/next-generation sequencing [NGS] of immunoglobulin
[Ig]/T-cell receptor [TCR] rearrangement, and/or PCR or NGS of fusion gene
identical to diagnosis), OR
- Relapse M2: M2 morphology (5-25% blasts) + 1 confirmatory test showing >
1% blasts, OR
- Relapse M3: M3 morphology (> 25% blasts)
- Primary refractory, or failure to achieve remission-1: remission-1 is defined
as < 1% marrow blasts by flow MRD and resolution of extramedullary disease
following at least 2 courses of frontline chemotherapy. Patients who receive 2
courses of chemotherapy and 1 course of blinatumomab are also eligible, but no
further treatment attempts beyond that are permitted
- Central nervous system (CNS) disease: Patients must have CNS1 or CNS2 status and no
clinical signs or neurologic symptoms suggestive of CNS leukemia, such as cranial
palsy.
- Patients with CNS3 disease may receive antecedent intrathecal chemotherapy to
achieve CNS1 or CNS2 status prior to enrollment.
- Patients with a history of CNS chloromatous disease are required to have no
radiographic evidence of CNS disease prior to enrollment.
- White blood cell (WBC) must be < 50,000/uL at the time of study enrollment. Patients
can receive cytoreduction with hydroxyurea and/or corticosteroids for up to 7 days
prior to enrollment.
- Patients >= 12 months of age must have a performance status by Lansky Scale of >=
50%.
- Patients must be able to take enteral medications. Acceptable routes of
administration for revumenib (SNDX-5613) include: oral (PO), nasogastric (NG) tube,
nasojejunal (NJ) tube, nasoduodenal (ND), and gastrostomy tube (G-tube).
- Patients must have fully recovered from the acute toxic effects of all prior
chemotherapy, immunotherapy, or radiotherapy prior to entering this study
- Cytotoxic chemotherapy or other anti-cancer agents known to be
myelosuppressive:
- >= 14 days must have elapsed after the completion of other cytotoxic
therapy, including patients who relapse during pre-Maintenance upfront
therapy, with these specific exceptions: cytoreduction with hydroxyurea
and/or corticosteroids, and intrathecal chemotherapy, which have no
required washout periods. For patients who relapse during upfront
Maintenance therapy, >= 7 days must have elapsed after the last dose of
chemotherapy. Additionally, patients must have fully recovered from all
acute toxic effects of prior therapy.
- NOTE: Cytoreduction with hydroxyurea and/or corticosteroids is
permitted prior to enrollment for patients with WBC >= 50,000/uL, and
by provider discretion regardless of WBC, to reduce potential risk of
differentiation syndrome with revumenib initiation. Hydroxyurea
and/or corticosteroids may be given for up to 7 days, with no
wash-out required.
- NOTE: No waiting period is required for patients having received
intrathecal cytarabine, methotrexate, and/or hydrocortisone.
Intrathecal chemotherapy that is given up to 7 days prior to the
initiation of protocol therapy counts as protocol therapy and not
prior anti-cancer therapy. Intrathecal chemotherapy given > 7 days
prior does not count as protocol therapy.
- NOTE: Prior exposure to fludarabine and cytarabine (FLA) is
permitted.
- Anti-cancer agents not known to be myelosuppressive (e.g., not associated with
reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after
the last dose of agent.
- Antibodies: >= 21 days must have elapsed from infusion of last dose of
antibody, and toxicity related to prior antibody therapy must be recovered to
grade =< 1. There is an exception for blinatumomab infusions, for which
patients must have been off for at least 3 days and all drug related toxicity
must have resolved to grade 2 or lower as outlined in the inclusion/exclusion
criteria.
- Hematopoietic growth factors: >= 14 days after the last dose of a long-acting
growth factor (e.g., pegfilgrastim) or >= 7 days for short-acting growth
factor. For agents that have known adverse events occurring beyond 7 days after
administration, this period must be extended beyond the time during which
adverse events are known to occur. The duration of this interval must be
discussed with the study chair and the study-assigned Research Coordinator.
- Interleukins, interferons and cytokines (other than hematopoietic growth
factors): >= 21 days after the completion of interleukins, interferon, or
cytokines
- Stem cell infusions (with or without total body irradiation (TBI):
- Allogeneic (non-autologous) bone marrow or stem cell transplant, or stem
cell boost: >= 84 days after infusion
- Donor leukocyte infusion: >= 28 days
- Cellular therapy: >= 28 days after the completion of any type of cellular
therapy (e.g., modified T cells, natural killer [NK] cells, dendritic cells,
etc.)
- Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days
after local XRT; >= 84 days after TBI, craniospinal XRT or if radiation to >=
50% of the pelvis; >= 42 days if other substantial bone marrow radiation.
- A creatinine based on age as follows:
- Age 1 month to < 6 months: maximum creatinine 0.4 mg/dL
- Age 6 months to < 1 year: maximum creatinine 0.5 mg/dL
- Age 1 to < 2 years: maximum creatinine 0.6 mg/dL
- Age 2 to < 6 years: maximum creatinine 0.8 mg/dL OR
- a 24-hour urine creatinine clearance >= 70 mL/min/1.73 m^2 OR
- a glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2. GFR must be
performed using direct measurement with a nuclear blood sampling method OR
direct small molecule clearance method (iothalamate or other molecule per
institutional standard).
- NOTE: Estimated GFR (eGFR) from creatinine, cystatin C or other estimates are
not acceptable for determining eligibility.
- A direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, unless disease
related
- Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135
U/L (3 x ULN) unless disease related.
- Note: For the purpose of eligibility, the ULN for SGPT (ALT) has been set to
the value of 45 U/L
- Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by
radionuclide angiogram.
- Corrected QT interval using Fridericia formula (QTcF) of < 450 msec (using the
average of triplicate measurements)
- NOTE: There are no specific electrolyte parameters for eligibility. However, it
should be noted that, to limit QTc prolongation risk, patients must maintain
adequate potassium and magnesium levels to initiate and continue revumenib
(SNDX-5613) on protocol therapy.
- Patients must be able to comply with the safety monitoring requirements of the
study, in the opinion of the treating investigator.
Exclusion Criteria:
- Patients with isolated extramedullary leukemia.
- Patients diagnosed with Down syndrome.
- Patients known to have one of the following syndromes:
- Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome,
Shwachman syndrome, or any other known bone marrow failure syndrome.
- Patients with a secondary KMT2A-R leukemia that developed after treatment of prior
malignancy with cytotoxic chemotherapy.
- Patients with a history of congenital prolonged QT syndrome, congestive heart
failure or uncontrolled arrhythmia in the past 6 months prior to study enrollment.
- Patients with an active, uncontrolled infection, further defined below:
- Positive bacterial blood culture within 48 hours of study enrollment
- Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with
clinical signs of infection. Fever that is determined to be due to tumor burden
is allowed if patients have documented negative blood cultures for at least 48
hours prior to enrollment and no concurrent signs or symptoms of active
infection or hemodynamic instability
- A positive fungal culture within 30 days of study enrollment or active therapy
for presumed invasive fungal infection
- Patients may be receiving IV or oral antibiotics to complete a course of
therapy for a prior documented infection as long as cultures have been negative
for at least 48 hours and signs or symptoms of active infection have resolved.
For patients with Clostridium (C.) difficile diarrhea, at least 72 hours of
antibacterial therapy must have elapsed and stools must have normalized to
baseline
- Active viral or protozoal infection requiring IV treatment
- Human immunodeficiency virus (HIV)-infected patients are eligible if on
effective anti-retroviral therapy that does not interact with planned study
agents and with undetectable viral load within 6 months of enrollment.
- Patients with active acute graft-versus-host disease (GVHD) > grade 0 (unless skin
only), or chronic GVHD > mild (unless skin only) are not eligible. Patients with
acute or chronic skin GVHD that is =< grade 1, or chronic skin GVHD that is graded
as mild are eligible.
- Patients who have received a prior solid organ transplantation.
- Patients with known Charcot-Marie-Tooth disease, if treating on Regimen A (with
vincristine).
- CYP3A4 Inhibitors or Inducers: Patients who require concomitant therapy with strong
CYP3A4 inhibitors or moderate or strong CYP3A4 inducers, as these are prohibited
during the chemotherapy combination cycles. These agents should be discontinued at
least 5 half-lives prior to starting protocol therapy. Concomitant use of strong
CYP3A4 inhibitor -azole antifungals are permitted during the revumenib (SNDX-5613)
monotherapy cycles, with appropriate revumenib (SNDX-5613) dose modification
- P-glycoprotein (P-gp) inhibitors or inducers: Vincristine is a substrate for P-gp.
Concomitant use of P-gp inhibitors or inducers with vincristine (patients receiving
Regimen A Cycle 1) should be avoided.
- Investigational drugs: Patients who are currently receiving another investigational
drug.
- Anti-cancer agents: Patients who are currently receiving other anti-cancer agents
(exceptions: hydroxyurea and corticosteroids, which may be used as cytoreduction
prior to enrollment).
- Anti-GVHD agents: Patients who are receiving cyclosporine, tacrolimus, or other
systemic agents to treat graft-versus-host disease post bone marrow transplant.
Patients should discontinue anti-GVHD agents > 7 days prior to enrollment and have
no evidence of worsening GVHD. Topical steroids are permitted.
- Patients who have previously been treated with revumenib (SNDX-5613). Prior exposure
to other menin inhibitors is permitted.
- All patients and/or their parents or legal guardians must sign a written informed
consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met.
Gender:
All
Minimum age:
1 Month
Maximum age:
6 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Hospital of Alabama
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
205-638-9285
Email:
oncologyresearch@peds.uab.edu
Investigator:
Last name:
Matthew A. Kutny
Email:
Principal Investigator
Facility:
Name:
Arkansas Children's Hospital
Address:
City:
Little Rock
Zip:
72202-3591
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
501-364-7373
Investigator:
Last name:
David L. Becton
Email:
Principal Investigator
Facility:
Name:
Loma Linda University Medical Center
Address:
City:
Loma Linda
Zip:
92354
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
909-558-4050
Investigator:
Last name:
Albert Kheradpour
Email:
Principal Investigator
Facility:
Name:
UCSF Benioff Children's Hospital Oakland
Address:
City:
Oakland
Zip:
94609
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
510-428-3264
Email:
cogbchoak@ucsf.edu
Investigator:
Last name:
Jennifer G. Michlitsch
Email:
Principal Investigator
Facility:
Name:
Kaiser Permanente-Oakland
Address:
City:
Oakland
Zip:
94611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-642-4691
Email:
Kpoct@kp.org
Investigator:
Last name:
Aarati V. Rao
Email:
Principal Investigator
Facility:
Name:
UCSF Medical Center-Mission Bay
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Elliot Stieglitz
Email:
Principal Investigator
Facility:
Name:
Children's Hospital Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
303-764-5056
Email:
josh.b.gordon@nsmtp.kp.org
Investigator:
Last name:
Kelly E. Faulk
Email:
Principal Investigator
Facility:
Name:
Alfred I duPont Hospital for Children
Address:
City:
Wilmington
Zip:
19803
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-651-5572
Email:
Allison.bruce@nemours.org
Investigator:
Last name:
Emi H. Caywood
Email:
Principal Investigator
Facility:
Name:
Children's National Medical Center
Address:
City:
Washington
Zip:
20010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
202-476-2800
Email:
OncCRC_OnCall@childrensnational.org
Investigator:
Last name:
Jeffrey S. Dome
Email:
Principal Investigator
Facility:
Name:
Golisano Children's Hospital of Southwest Florida
Address:
City:
Fort Myers
Zip:
33908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
239-343-5333
Email:
molly.arnstrom@leehealth.org
Investigator:
Last name:
Emad K. Salman
Email:
Principal Investigator
Facility:
Name:
University of Florida Health Science Center - Gainesville
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
352-273-8010
Email:
cancer-center@ufl.edu
Investigator:
Last name:
William B. Slayton
Email:
Principal Investigator
Facility:
Name:
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
954-265-1847
Email:
OHR@mhs.net
Investigator:
Last name:
Iftikhar Hanif
Email:
Principal Investigator
Facility:
Name:
Nicklaus Children's Hospital
Address:
City:
Miami
Zip:
33155
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-624-2778
Investigator:
Last name:
Maggie E. Fader
Email:
Principal Investigator
Facility:
Name:
AdventHealth Orlando
Address:
City:
Orlando
Zip:
32803
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
407-303-2090
Email:
FH.Cancer.Research@flhosp.org
Investigator:
Last name:
Fouad M. Hajjar
Email:
Principal Investigator
Facility:
Name:
Nemours Children's Hospital
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-651-5572
Email:
Allison.bruce@nemours.org
Investigator:
Last name:
Emi H. Caywood
Email:
Principal Investigator
Facility:
Name:
Saint Joseph's Hospital/Children's Hospital-Tampa
Address:
City:
Tampa
Zip:
33607
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
813-357-0849
Email:
jennifer.manns@baycare.org
Investigator:
Last name:
Don E. Eslin
Email:
Principal Investigator
Facility:
Name:
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Address:
City:
Atlanta
Zip:
30329
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
404-785-2025
Email:
Leann.Schilling@choa.org
Investigator:
Last name:
Melinda G. Pauly
Email:
Principal Investigator
Facility:
Name:
Lurie Children's Hospital-Chicago
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
773-880-4562
Investigator:
Last name:
Sara Zarnegar-Lumley
Email:
Principal Investigator
Facility:
Name:
University of Chicago Comprehensive Cancer Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
773-702-8222
Email:
cancerclinicaltrials@bsd.uchicago.edu
Investigator:
Last name:
Gabrielle Lapping-Carr
Email:
Principal Investigator
Facility:
Name:
Riley Hospital for Children
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-248-1199
Investigator:
Last name:
Amanda Saraf
Email:
Principal Investigator
Facility:
Name:
University of Iowa/Holden Comprehensive Cancer Center
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-237-1225
Investigator:
Last name:
David S. Dickens
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins University/Sidney Kimmel Cancer Center
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
410-955-8804
Email:
jhcccro@jhmi.edu
Investigator:
Last name:
Stacy L. Cooper
Email:
Principal Investigator
Facility:
Name:
C S Mott Children's Hospital
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-865-1125
Investigator:
Last name:
Joshua W. Goldman
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Michigan
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Email:
helpdesk@childrensoncologygroup.org
Investigator:
Last name:
Meret Henry
Email:
Principal Investigator
Facility:
Name:
Bronson Methodist Hospital
Address:
City:
Kalamazoo
Zip:
49007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
616-391-1230
Email:
crcwm-regulatory@crcwm.org
Investigator:
Last name:
Kathleen J. Yost
Email:
Principal Investigator
Facility:
Name:
University of Minnesota/Masonic Cancer Center
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
612-624-2620
Investigator:
Last name:
Peter M. Gordon
Email:
Principal Investigator
Facility:
Name:
University of Mississippi Medical Center
Address:
City:
Jackson
Zip:
39216
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
601-815-6700
Investigator:
Last name:
Betty L. Herrington
Email:
Principal Investigator
Facility:
Name:
Children's Mercy Hospitals and Clinics
Address:
City:
Kansas City
Zip:
64108
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
816-302-6808
Email:
rryan@cmh.edu
Investigator:
Last name:
Kevin F. Ginn
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Jeffrey A. Magee
Email:
Principal Investigator
Facility:
Name:
Mercy Hospital Saint Louis
Address:
City:
Saint Louis
Zip:
63141
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
314-251-7066
Investigator:
Last name:
Robin D. Hanson
Email:
Principal Investigator
Facility:
Name:
Children's Hospital and Medical Center of Omaha
Address:
City:
Omaha
Zip:
68114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-955-3949
Investigator:
Last name:
Jill C. Beck
Email:
Principal Investigator
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
402-559-6941
Email:
unmcrsa@unmc.edu
Investigator:
Last name:
Jill C. Beck
Email:
Principal Investigator
Facility:
Name:
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Address:
City:
Las Vegas
Zip:
89135
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
Alan K. Ikeda
Email:
Principal Investigator
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
551-996-2897
Investigator:
Last name:
Jing Chen
Email:
Principal Investigator
Facility:
Name:
Newark Beth Israel Medical Center
Address:
City:
Newark
Zip:
07112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
973-926-7230
Email:
Christine.Kosmides@rwjbh.org
Investigator:
Last name:
Teena Bhatla
Email:
Principal Investigator
Facility:
Name:
Albany Medical Center
Address:
City:
Albany
Zip:
12208
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
518-262-5513
Investigator:
Last name:
Lauren R. Weintraub
Email:
Principal Investigator
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-767-9355
Email:
askroswell@roswellpark.org
Investigator:
Last name:
Kanwaldeep K. Mallhi
Email:
Principal Investigator
Facility:
Name:
State University of New York Upstate Medical University
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
315-464-5476
Investigator:
Last name:
Melanie A. Comito
Email:
Principal Investigator
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-668-0683
Email:
cancerclinicaltrials@med.unc.edu
Investigator:
Last name:
Thomas B. Alexander
Email:
Principal Investigator
Facility:
Name:
Children's Hospital Medical Center of Akron
Address:
City:
Akron
Zip:
44308
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
330-543-3193
Investigator:
Last name:
Erin Wright
Email:
Principal Investigator
Facility:
Name:
Cincinnati Children's Hospital Medical Center
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
513-636-2799
Email:
cancer@cchmc.org
Investigator:
Last name:
Erin H. Breese
Email:
Principal Investigator
Facility:
Name:
Nationwide Children's Hospital
Address:
City:
Columbus
Zip:
43205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
614-722-6039
Email:
Melinda.Triplet@nationwidechildrens.org
Investigator:
Last name:
Mark A. Ranalli
Email:
Principal Investigator
Facility:
Name:
Dayton Children's Hospital
Address:
City:
Dayton
Zip:
45404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-228-4055
Investigator:
Last name:
Jordan M. Wright
Email:
Principal Investigator
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-494-1080
Email:
trials@ohsu.edu
Investigator:
Last name:
Bill H. Chang
Email:
Principal Investigator
Facility:
Name:
Geisinger Medical Center
Address:
City:
Danville
Zip:
17822
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
570-271-5251
Email:
HemonCCTrials@geisinger.edu
Investigator:
Last name:
Jagadeesh Ramdas
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
267-425-5544
Email:
CancerTrials@email.chop.edu
Investigator:
Last name:
Kathrin M. Bernt
Email:
Principal Investigator
Facility:
Name:
Saint Christopher's Hospital for Children
Address:
City:
Philadelphia
Zip:
19134
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
215-427-8991
Investigator:
Last name:
Gregory E. Halligan
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Pittsburgh of UPMC
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
412-692-8570
Email:
jean.tersak@chp.edu
Investigator:
Last name:
Jenny Ruiz
Email:
Principal Investigator
Facility:
Name:
Prisma Health Richland Hospital
Address:
City:
Columbia
Zip:
29203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-241-6251
Investigator:
Last name:
Stuart L. Cramer
Email:
Principal Investigator
Facility:
Name:
BI-LO Charities Children's Cancer Center
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
864-241-6251
Investigator:
Last name:
Aniket Saha
Email:
Principal Investigator
Facility:
Name:
Saint Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-226-4343
Email:
referralinfo@stjude.org
Investigator:
Last name:
Matthew Rees
Email:
Principal Investigator
Facility:
Name:
The Children's Hospital at TriStar Centennial
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
615-342-1919
Investigator:
Last name:
Jennifer A. Domm
Email:
Principal Investigator
Facility:
Name:
Vanderbilt University/Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-811-8480
Investigator:
Last name:
Brianna N. Smith
Email:
Principal Investigator
Facility:
Name:
Dell Children's Medical Center of Central Texas
Address:
City:
Austin
Zip:
78723
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
512-628-1902
Email:
TXAUS-DL-SFCHemonc.research@ascension.org
Investigator:
Last name:
Shannon M. Cohn
Email:
Principal Investigator
Facility:
Name:
Medical City Dallas Hospital
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
972-566-5588
Investigator:
Last name:
Stanton C. Goldman
Email:
Principal Investigator
Facility:
Name:
UT Southwestern/Simmons Cancer Center-Dallas
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
214-648-7097
Email:
canceranswerline@UTSouthwestern.edu
Investigator:
Last name:
Caroline Smith
Email:
Principal Investigator
Facility:
Name:
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
713-798-1354
Email:
burton@bcm.edu
Investigator:
Last name:
Joanna S. Yi
Email:
Principal Investigator
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-632-6789
Email:
askmdanderson@mdanderson.org
Investigator:
Last name:
Najat C. Daw
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of San Antonio
Address:
City:
San Antonio
Zip:
78207
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
210-704-2894
Email:
bridget.medina@christushealth.org
Investigator:
Last name:
Julie Voeller
Email:
Principal Investigator
Facility:
Name:
University of Virginia Cancer Center
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
434-243-6303
Email:
uvacancertrials@hscmail.mcc.virginia.edu
Investigator:
Last name:
Brian C. Belyea
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of The King's Daughters
Address:
City:
Norfolk
Zip:
23507
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
757-668-7243
Email:
CCBDCresearch@chkd.org
Investigator:
Last name:
Eric J. Lowe
Email:
Principal Investigator
Facility:
Name:
Seattle Children's Hospital
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
866-987-2000
Investigator:
Last name:
Sarah E. Leary
Email:
Principal Investigator
Start date:
January 8, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Children's Oncology Group
Agency class:
Other
Source:
Children's Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05761171
