Trial Title:
Cord Blood Transplant in Adults With Blood Cancers
NCT ID:
NCT05884333
Condition:
Acute Myelogenous Leukemia (AML)
Acute Lymphoblastic Leukemia (ALL)
Chronic Myelogenous Leukemia (CML)
Myelodysplastic Syndromes (MDS)
Myeloproliferative Disorder
Non-Hodgkin's Lymphoma
Conditions: Official terms:
Leukemia
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Myeloproliferative Disorders
Conditions: Keywords:
Cord Blood Transplant
CYCLOPHOSPHAMIDE (CYTOXAN)
CYCLOSPORINE A
FLUDARABINE
MYCOPHENOLATE MOFETIL (MMF)
THIOTEPA
23-143
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a phase II study of optimized cord blood transplantation (CBT) in adults with
high risk or advanced hematologic malignancies.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Conditioning Chemotherapy
Description:
Conditioning: Cyclophosphamide (CY) 50 mg/kg x1 (day -6), Fludarabine (FLU) 30 mg/m2 x5
(days -6 to -2), Thiotepa (THIO) 5 mg/kg x2 (days -5 & -4), Total Body Irradiation (TBI)
200 cGy x2 (days -2 & -1). GVHD prophylaxis: Cyclosporine (CSA) 3 mg/kg q12 hours &
Mycophenolate Mofetil (MMF) 15 mg/kg q8 hours (starting IV day -3).
Arm group label:
Cord Blood Transplant
Intervention type:
Biological
Intervention name:
Cord blood graft
Description:
The double-unit CB graft will be infused on day 0 per standard practice.
Arm group label:
Cord Blood Transplant
Summary:
Cord blood transplants (CBT) are a standard treatment for adults with blood cancers. MSK
has developed a standard ("optimized") practice for cord blood transplant (CBT). This
optimized practice includes how patients are evaluated for transplant, the conditioning
treatment (standard chemotherapy and total body irradiation therapy) given to prepare the
body for transplant, the amount of stem cells transplanted, and how patients are followed
during and after transplant.The purpose of this study is to collect information about
participant outcomes after CBT following MSK's optimized practice. The researchers will
look at outcomes of the CBT treatment such as side effects, disease relapse, GVHD, and
immune system recovery after CBT treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- I. Acute myelogenous leukemia (AML):
- Complete first remission (CR1) at high risk for relapse such as any of the
following:
- Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder
(MPD).
- Therapy-related AML.
- Presence of extramedullary leukemia at diagnosis.
- Requirement for 2 or more inductions to achieve CR1.
- Intermediate or high ELN2017 genetic risk AML.
- Any patient unable to tolerate consolidation chemotherapy as would have been
deemed appropriate by the treating physician.
- Other high-risk features not defined above.
- Complete second remission (CR2) or greater (CR2+).
- Patients in morphologic remission with persistent cytogenetic, flow cytometric, or
molecular aberrations are eligible
II. Acute lymphoblastic leukemia (ALL):
- Complete first remission (CR1) at high risk for relapse such as any of the
following:
- Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19),
t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular
abnormality.
- Failure to achieve MRD- complete remission after induction therapy.
- Persistence or recurrence of minimal residual disease on therapy.
- Any patient unable to tolerate consolidation and/or maintenance chemotherapy as
would have been deemed appropriate by the treating physician.
- Other high-risk features not defined above.
- Complete second remission (CR2) or greater (CR2+). Note: ALL with less than 5%
blasts at time of transplant but persistent cytogenetic, flow cytometric or
molecular aberrations are eligible.
III. Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with
less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow
cytometric or molecular aberrations are eligible.
IV. Myelodysplastic Syndromes (MDS) and Myeloproliferative Disorders (MPD) other than
myelofibrosis:
- International prognostic scoring system (IPSS) risk score of INT-2 or high risk at
the time of diagnosis.
- Any IPSS risk category if life-threatening cytopenia(s) exists.
- Any IPSS risk category with karyotype or genomic changes that indicate high risk for
progression to acute myelogenous leukemia.
- MDS/MPD overlap syndromes without myelofibrosis.
- MDS/ MPD patients must have less than 10% bone marrow myeloblasts and ANC > 0.2
(growth factor supported if necessary) at transplant work-up.
V. Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:
Eligible patients with aggressive histologies (such as, but not limited to, diffuse large
B-cell NHL, mantle cell NHL, and T-cell histologies) in CR by PET/CT imaging.
o Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular,
small cell or marginal zone NHL) will have 2 nd or subsequent progression with PR or CR
by PET/CT imaging.
VI. Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.
Prior treatment:
To prevent graft rejection, patients who received only non-lymphodepleting agents for
their malignancy (hypomethylating agents, venetoclax, hydroxyurea, TKIs etc.), or
patients who received lymphodepleting chemotherapy > 3 months prior to scheduled
admission, should receive fludarabine 25 mg/m2 daily x 3 days for lymphodepletion 14-42
days (aiming for 2-4 weeks) prior to admission in order to qualify for the protocol.
Organ Function and Performance Status Criteria:
- Karnofsky score equal or greater than 80% (See Appendix B; inpatient Leukemia
service transfers without discharge are acceptable provided patient has equivalent
KPS as if were outpatient).
- Calculated creatinine clearance > 70 ml/min.
- Bilirubin < 1.5 mg/dL (unless benign congenital hyperbilirubinemia or hemolysis).
- ALT < 3 x upper limit of normal (ULN).
- Pulmonary function: Spirometry (FVC and FEV1) and corrected DLCO) > 60% predicted.
- Left ventricular ejection fraction (MOD-bp)> 50%.
- Albumin > 3.0.
- Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) ≤5.
Graft criteria:
Two CB units will be selected according to current MSKCC CB unit selection algorithm.
High resolution 8-allele HLA typing and recipient HLA antibody profile will be performed.
Unit selection will occur based on HLA-match, total nucleated cell (TNC) and CD34+ cell
dose adjusted per patient body weight. The bank of origin will also be considered. Donor
specific HLA antibodies, if present, will also be taken into consideration and may
influence the selection of the graft.
- Each CB unit must be at least 3/8 HLA-matched to the patient considering
high-resolution 8-allele HLA typing. [Taken from the Cord Blood Summary]
- Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x
10^7 TNC/ recipient body weight (TNC/ kg). [Taken from the Cord Blood Summary]
- Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least
1.5 x 10^5 CD34+ cells/ recipient body weight (CD34+ cells/kg). [Taken from the Cord
Blood Summary]
- A minimum of one unit will be reserved as a backup graft. [Taken from the Cord Blood
Summary]
- Each CB unit will be required to be cryopreserved in standard cryovolume (24-27 ml/s
per unit or per bag if unit in two bags) and be red blood cell depleted. [Taken from
the Cord Blood Summary]
Exclusion Criteria:
- Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow
fibrosis.
- Patients persistent with CNS involvement in CSF or CNS imaging at time of screening
- Prior checkpoint inhibitors/ blockade in the last 12 months.
- Two prior stem cell transplants of any kind.
- One prior autologous stem cell transplant within the preceding 12 months.
- Prior allogeneic transplantation.
- Prior involved field radiation therapy that would preclude safe delivery of 400cGy
TBI in the opinion of Radiation Oncology.
- Active and uncontrolled infection at time of transplantation.
- HIV infection.
- Seropositivity for HTLV-1.
- Inadequate performance status/ organ function.
- Pregnancy or breast feeding.
- Patient or guardian unable to give informed consent or unable to comply with the
treatment protocol including appropriate supportive care, long-term follow-up, and
research tests.
Gender:
All
Minimum age:
21 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Consent only)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ioannis Politikos, MD
Phone:
646-608-3773
Facility:
Name:
Memorial Sloan Kettering Monmouth (Consent only)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ioannis Politikos, MD
Phone:
646-608-3773
Facility:
Name:
Memorial Sloan Kettering Bergen (Consent only)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ioannis Politikos, MD
Phone:
646-608-3773
Facility:
Name:
Memorial Sloan Kettering Suffolk-Commack (Consent only)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ioannis Politikos, MD
Phone:
646-608-3773
Facility:
Name:
Memorial Sloan Kettering Westchester (Consent only)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ioannis Politikos, MD
Phone:
646-608-3773
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ioannis Politikos, MD
Phone:
646-608-3773
Email:
ABMTTrials@mskcc.org
Contact backup:
Last name:
Juliet Barker, MBBS
Phone:
646-608-3756
Facility:
Name:
Memorial Sloan Kettering Nassau (Consent only)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ioannis Politikos, MD
Phone:
646-608-3773
Start date:
May 22, 2023
Completion date:
May 22, 2028
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05884333
http://www.mskcc.org/mskcc/html/44.cfm
