Trial Title:
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
NCT ID:
NCT05554393
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Azacitidine
Venetoclax
Daunorubicin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
Given IV or SC
Arm group label:
ARM II (azacitidine, venetoclax)
Other name:
5 AZC
Other name:
5-AC
Other name:
5-Azacitidine
Other name:
5-Azacytidine
Other name:
5-AZC
Other name:
Azacytidine
Other name:
Azacytidine, 5-
Other name:
Ladakamycin
Other name:
Mylosar
Other name:
U-18496
Other name:
Vidaza
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
ARM I (daunorubicin, cytarabine, venetoclax)
Arm group label:
ARM II (azacitidine, venetoclax)
Arm group label:
ARM III (daunorubicin, cytarabine)
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:
ARM I (daunorubicin, cytarabine, venetoclax)
Arm group label:
ARM II (azacitidine, venetoclax)
Arm group label:
ARM III (daunorubicin, cytarabine)
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Given IV
Arm group label:
ARM I (daunorubicin, cytarabine, venetoclax)
Arm group label:
ARM III (daunorubicin, cytarabine)
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:
Drug
Intervention name:
Daunorubicin Hydrochloride
Description:
Given IV
Arm group label:
ARM I (daunorubicin, cytarabine, venetoclax)
Arm group label:
ARM III (daunorubicin, cytarabine)
Other name:
Cerubidin
Other name:
Cerubidine
Other name:
Cloridrato de Daunorubicina
Other name:
Daunoblastin
Other name:
Daunoblastina
Other name:
Daunoblastine
Other name:
Daunomycin Hydrochloride
Other name:
Daunomycin, hydrochloride
Other name:
Daunorubicin.HCl
Other name:
Daunorubicini Hydrochloridum
Other name:
FI-6339
Other name:
Ondena
Other name:
RP-13057
Other name:
Rubidomycin Hydrochloride
Other name:
Rubilem
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Given PO
Arm group label:
ARM I (daunorubicin, cytarabine, venetoclax)
Arm group label:
ARM II (azacitidine, venetoclax)
Other name:
ABT 199
Other name:
ABT-0199
Other name:
ABT-199
Other name:
ABT199
Other name:
GDC 0199
Other name:
GDC-0199
Other name:
GDC0199
Other name:
RG7601
Other name:
Venclexta
Other name:
Venclyxto
Summary:
This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus
cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the
treatment of younger patients with intermediate risk acute myeloid leukemia (AML).
Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid
(DNA) replication and repair and can slow or stop the growth of cancer cells.
Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA
repair, and it may kill cancer cells. Venetoclax is in a class of medications called
B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking
Bcl-2, a protein needed for cancer cell survival. Azacitidine is a drug that interacts
with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding
venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work
better than the usual treatment of cytarabine with daunorubicin alone. To decide if they
are better, the study doctors are looking to see if venetoclax increases the rate of
elimination of AML in participants by 20% or more compared to the usual approach.
Detailed description:
PRIMARY OBJECTIVE:
I. To compare the rates of undetectable measurable residual disease (MRD) in patients who
achieve a complete remission (CR) after induction therapy with 7 +3 (cytarabine +
daunorubicin hydrochloride [daunorubicin]) versus (vs.) azacitidine + venetoclax vs. 7+3
+ venetoclax.
SECONDARY OBJECTIVES:
I. To estimate the frequency and severity of toxicities with each of the regimens.
II. To estimate complete remission (CR) rates (with and without MRD), complete remission
with incomplete count recovery (CRi) (with and without MRD) rates, event-free survival
(EFS), relapse-free survival (RFS), and overall survival (OS) with each of the regimens.
TERTIARY OBJECTIVES:
I. To evaluate response to therapy received according to genomic findings. II. To
evaluate MRD kinetics by following patients with detectable MRD through Tier 2 and
beyond.
III. To evaluate longer term outcomes by treatment arm, genomics, MRD outcome, and other
features as patients receive additional myeloMATCH therapies to generate testable
hypotheses for more precise patient selection for these therapies.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive daunorubicin intravenously (IV) on days 2-4, cytarabine IV
continuously on days 2-8, and venetoclax orally (PO) once per day (QD) on days 1-11.
Cycle is 28 days and treatment is given in the absence of disease progression or
unacceptable toxicity. Based on a bone marrow aspiration assessment, patients may receive
reinduction consisting of daunorubicin IV on days 2-3, cytarabine IV continuously on days
2-6, and venetoclax PO QD on days 1-8. Cycle is 28 days and treatment is given in the
absence of disease progression or unacceptable toxicity. Patients also undergo bone
marrow aspiration and collection of blood samples on study and as clinically indicated.
ARM II: Patients receive azacitidine IV or subcutaneously (SC) on days 1-7 or days 1-5
and 8-9 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for a
total of 2 cycles, in the absence of disease progression or unacceptable toxicity.
Patients also undergo bone marrow aspiration and collection of blood samples on study and
as clinically indicated.
ARM III: Patients receive daunorubicin IV on days 1-3 and cytarabine IV, continuously, on
days 1-7. Cycle is 28 days and treatment is given in the absence of disease progression
or unacceptable toxicity. Based on a bone marrow aspiration assessment, patients may
receive reinduction consisting of cytarabine IV, continuously, on days 1-5 and
daunorubicin IV on days 1-2. Cycle is 28 days and treatment is given in the absence of
disease progression or unacceptable toxicity. Patients also undergo bone marrow
aspiration and collection of blood samples on study and as clinically indicated.
After completion of study treatment, patients are followed up at 4 weeks, every 3 months
for 1 year every 6 months for the second year and yearly thereafter.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient must have enrolled onto MYELOMATCH and must have been given a treatment
assignment to MyeloMATCH to MM1YA-CTG01 based on the presence of an actionable
mutation as defined in MYELOMATCH
- Participants must have been registered to master screening and re-assessment
protocol (myeloMATCH MSRP) prior to consenting to this study. Participants must have
been assigned to this clinical trial, via MATCHBox, prior to registration to this
study. Participants must have agreed to have specimens submitted for translational
medicine (MRD) and must be offered the opportunity to submit biosamples for banking
for future research as per the myeloMATCH MSRP
- Note: Pre-enrollment/diagnosis labs must have already been performed under the
MSRP
- Previously untreated, de novo acute myeloid leukemia (AML) defined by > 20%
myeloblasts in the peripheral blood or bone marrow (refer to the 2016 updated World
Health Organization [WHO] classification of myeloid neoplasms and acute leukemia)
excluding all the following categories of AML:
- Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1, inversion
16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11
- CEBPA biallelic mutations
- NPM1 mutation
- AML with PML-RARalpha
- AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1,
11q23/KMT2 rearrangements
- AML with FLT3-ITD or FLT3-TKD mutations
- Therapy related AML, or AML following a diagnosis of myelodysplasia or
myeloproliferative neoplasm Participants with central nervous system (CNS)
disease are eligible for this trial and will be treated according to
institutional guidelines with intrathecal chemotherapy for this aspect of their
disease
- Age 18-59 years at time of induction therapy
- Eastern Cooperative Oncology Group (ECOG) performance status =< 3
- Total bilirubin =< 2 x institutional upper limit of normal (ULN) (must be done
within 7 days of enrollment)
- Aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase [SGPT]) +/or
alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 3
× institutional ULN (must be done within 7 days of enrollment)
- Cardiac ejection fraction >= 50% (echocardiography or multigated acquisition scan
[MUGA]) (must be done within 7 days of enrollment)
- Calculated creatinine clearance >= 30 mL/min/ 1.73m^2; Clearance to be calculated
using Cockcroft formula (must be done within 7 days of enrollment)
- White blood cells (WBC) must be < 25 x 10^9/L. Hydroxyurea and leukapheresis are
permitted to control the WBC prior to enrollment and initiation of protocol-defined
therapy but must be stopped at least 24 hours prior to the initiation of protocol
therapy
- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class 2B or better
- Women/men of childbearing potential must have agreed to use a highly effective
contraceptive method while on treatment and for 6 months after stopping study drug.
A woman is considered to be of "childbearing potential" if she has had menses at any
time in the preceding 12 consecutive months. In addition to routine contraceptive
methods, "effective contraception" also includes heterosexual celibacy and surgery
intended to prevent pregnancy (or with a side-effect of pregnancy prevention)
defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or
vasectomy/vasectomized partner. However, if at any point a previously celibate
patient chooses to become heterosexually active during the time period for use of
contraceptive measures outlined in the protocol, he/she is responsible for beginning
contraceptive measures.
Women of childbearing potential will have a pregnancy test to determine eligibility as
part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if
a false-positive is suspected. Patient will be considered eligible if an ultrasound is
negative for pregnancy
- Patient consent must be appropriately obtained in accordance with applicable local
and regulatory requirements. Each patient must sign a consent form prior to
enrollment in the trial to document their willingness to participate
- Patients must be accessible for treatment, response assessment and follow up.
Patients enrolled on this trial must be treated and followed at the participating
centre. Investigators must assure themselves the patients enrolled on this trial
will be available for complete documentation of the treatment, adverse events, and
follow-up.
Patients must agree to return to their primary care facility for any adverse events which
may occur through the course of the trial
- In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is
to begin within 7 working days of patient enrollment
- Participants receiving strong or moderate CYP3A inhibitors must agree to discontinue
use at least 48 hours prior to start of study treatment if assigned to arm 1 or 2
- Patients with known human immunodeficiency virus (HIV) infection who are on
effective anti-retroviral therapy and have undetectable viral load within 6 months
of enrollment are eligible for this trial
- Participants with evidence of chronic hepatitis B virus (HBV) infection must have
undetectable HBV viral load within 28 days of enrollment. Patients need to be on
suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection who have been treated
and cured are eligible. Patients who with active HCV infection who are currently
being treated must have an undetectable HCV viral load within 28 days of enrollment
to be eligible
Exclusion Criteria:
- Prior therapy for AML except for hydroxyurea and leukapheresis to control blood
counts. The use of all-trans retinoic acid (ATRA) is permitted until a diagnosis of
acute promyelocytic leukemia, if suspected, is ruled out
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to cytarabine, daunorubicin, azacitidine, venetoclax
- Pregnant women are excluded from this study because venetoclax, cytarabine and
azacitidine have the potential for teratogenic or abortifacient effects. Because
there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother with venetoclax, cytarabine and azacitidine
breastfeeding should be discontinued if the mother is treated with venetoclax,
cytarabine and azacitidine. These potential risks may also apply to other agents
used in this study
- Patients with isolated myeloid sarcoma are not eligible
- Any other serious intercurrent illness, life threatening condition, organ system
dysfunction, or medical condition judged by the local investigator to compromise the
subject's safety (for example):
- Active, uncontrolled bacterial, fungal, or viral infection
Gender:
All
Minimum age:
18 Years
Maximum age:
59 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Kootenai Health - Coeur d'Alene
Address:
City:
Coeur d'Alene
Zip:
83814
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Kootenai Clinic Cancer Services - Post Falls
Address:
City:
Post Falls
Zip:
83854
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Kootenai Clinic Cancer Services - Sandpoint
Address:
City:
Sandpoint
Zip:
83864
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Centralia Oncology Clinic
Address:
City:
Centralia
Zip:
62801
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
312-695-1301
Email:
cancer@northwestern.edu
Investigator:
Last name:
Shira N. Dinner
Email:
Principal Investigator
Facility:
Name:
Cancer Care Specialists of Illinois - Decatur
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Decatur Memorial Hospital
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Crossroads Cancer Center
Address:
City:
Effingham
Zip:
62401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-876-4762
Email:
morganthaler.jodi@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Southern Illinois University School of Medicine
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-545-7929
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Springfield Clinic
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-444-7541
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
Springfield Memorial Hospital
Address:
City:
Springfield
Zip:
62781
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
217-528-7541
Email:
pallante.beth@mhsil.com
Investigator:
Last name:
Bryan A. Faller
Email:
Principal Investigator
Facility:
Name:
University of Kansas Clinical Research Center
Address:
City:
Fairway
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Heather J. Male
Email:
Principal Investigator
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Heather J. Male
Email:
Principal Investigator
Facility:
Name:
University of Kansas Hospital-Indian Creek Campus
Address:
City:
Overland Park
Zip:
66211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Heather J. Male
Email:
Principal Investigator
Facility:
Name:
University of Kansas Hospital-Westwood Cancer Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
913-588-3671
Email:
KUCC_Navigation@kumc.edu
Investigator:
Last name:
Heather J. Male
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Address:
City:
Brighton
Zip:
48114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Canton
Address:
City:
Canton
Zip:
48188
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Address:
City:
Chelsea
Zip:
48118
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Genesee Cancer and Blood Disease Treatment Center
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Genesee Hematology Oncology PC
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Genesys Hurley Cancer Institute
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Hurley Medical Center
Address:
City:
Flint
Zip:
48503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
810-762-8038
Email:
wstrong@ghci.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Trinity Health Saint Mary Mercy Livonia Hospital
Address:
City:
Livonia
Zip:
48154
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Address:
City:
Ypsilanti
Zip:
48197
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
734-712-7251
Email:
MCRCwebsitecontactform@stjoeshealth.org
Investigator:
Last name:
Tareq Al baghdadi
Email:
Principal Investigator
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Address:
City:
Columbus
Zip:
39705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Salil Goorha
Email:
Principal Investigator
Facility:
Name:
Baptist Cancer Center-Grenada
Address:
City:
Grenada
Zip:
38901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Salil Goorha
Email:
Principal Investigator
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Union County
Address:
City:
New Albany
Zip:
38652
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Salil Goorha
Email:
Principal Investigator
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Oxford
Address:
City:
Oxford
Zip:
38655
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Salil Goorha
Email:
Principal Investigator
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Desoto
Address:
City:
Southhaven
Zip:
38671
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Salil Goorha
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at West County Hospital
Address:
City:
Creve Coeur
Zip:
63141
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Ramzi Abboud
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:
Ramzi Abboud
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center-South County
Address:
City:
Saint Louis
Zip:
63129
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Ramzi Abboud
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at Christian Hospital
Address:
City:
Saint Louis
Zip:
63136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Ramzi Abboud
Email:
Principal Investigator
Facility:
Name:
Siteman Cancer Center at Saint Peters Hospital
Address:
City:
Saint Peters
Zip:
63376
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Ramzi Abboud
Email:
Principal Investigator
Facility:
Name:
Billings Clinic Cancer Center
Address:
City:
Billings
Zip:
59101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-996-2663
Email:
research@billingsclinic.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Bozeman Health Deaconess Hospital
Address:
City:
Bozeman
Zip:
59715
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Benefis Sletten Cancer Institute
Address:
City:
Great Falls
Zip:
59405
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Logan Health Medical Center
Address:
City:
Kalispell
Zip:
59901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
Community Medical Center
Address:
City:
Missoula
Zip:
59804
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
406-969-6060
Email:
mccinfo@mtcancer.org
Investigator:
Last name:
John M. Schallenkamp
Email:
Principal Investigator
Facility:
Name:
OptumCare Cancer Care at Seven Hills
Address:
City:
Henderson
Zip:
89052
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
John A. Ellerton
Email:
Principal Investigator
Facility:
Name:
OptumCare Cancer Care at Charleston
Address:
City:
Las Vegas
Zip:
89102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
John A. Ellerton
Email:
Principal Investigator
Facility:
Name:
OptumCare Cancer Care at Fort Apache
Address:
City:
Las Vegas
Zip:
89148
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
702-384-0013
Email:
research@sncrf.org
Investigator:
Last name:
John A. Ellerton
Email:
Principal Investigator
Facility:
Name:
University of New Mexico Cancer Center
Address:
City:
Albuquerque
Zip:
87106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
505-925-0348
Email:
HSC-ClinicalTrialInfo@salud.unm.edu
Investigator:
Last name:
Charles Foucar
Email:
Principal Investigator
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
405-271-8777
Email:
ou-clinical-trials@ouhsc.edu
Investigator:
Last name:
Manu Pandey
Email:
Principal Investigator
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Providence Saint Vincent Medical Center
Address:
City:
Portland
Zip:
97225
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Charles W. Drescher
Email:
Principal Investigator
Facility:
Name:
Reading Hospital
Address:
City:
West Reading
Zip:
19611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
610-988-9323
Investigator:
Last name:
Terrence P. Cescon
Email:
Principal Investigator
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Collierville
Address:
City:
Collierville
Zip:
38017
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Salil Goorha
Email:
Principal Investigator
Facility:
Name:
Baptist Memorial Hospital and Cancer Center-Memphis
Address:
City:
Memphis
Zip:
38120
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
901-226-1366
Email:
BCCclintrials@bmhcc.org
Investigator:
Last name:
Salil Goorha
Email:
Principal Investigator
Facility:
Name:
Inova Schar Cancer Institute
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
703-720-5210
Email:
Stephanie.VanBebber@inova.org
Investigator:
Last name:
Danielle A. Shafer
Email:
Principal Investigator
Facility:
Name:
Inova Fairfax Hospital
Address:
City:
Falls Church
Zip:
22042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
703-208-6650
Email:
Stephanie.VanBebber@inova.org
Investigator:
Last name:
Danielle A. Shafer
Email:
Principal Investigator
Facility:
Name:
Gundersen Lutheran Medical Center
Address:
City:
La Crosse
Zip:
54601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
608-775-2385
Email:
cancerctr@gundersenhealth.org
Investigator:
Last name:
Kurt Oettel
Email:
Principal Investigator
Facility:
Name:
Tom Baker Cancer Centre
Address:
City:
Calgary
Zip:
T2N 4N2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
403-521-3433
Investigator:
Last name:
Mary L. Savoie
Email:
Principal Investigator
Facility:
Name:
Centro Comprensivo de Cancer de UPR
Address:
City:
San Juan
Zip:
00927
Country:
Puerto Rico
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
888-823-5923
Email:
ctsucontact@westat.com
Investigator:
Last name:
Luis J. Santos Reyes
Email:
Principal Investigator
Facility:
Name:
San Juan City Hospital
Address:
City:
San Juan
Zip:
00936
Country:
Puerto Rico
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
787-763-1296
Investigator:
Last name:
Luis J. Santos Reyes
Email:
Principal Investigator
Start date:
September 13, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05554393
