Cord Blood Transplant in Adults With Blood Cancers
Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults
1 other identifier
interventional
54
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2023
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2023
CompletedStudy Start
First participant enrolled
May 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 22, 2028
September 8, 2025
September 1, 2025
5 years
May 22, 2023
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
1 year post transplant
Secondary Outcomes (1)
Time to neutrophil engraftment
Up to day 45 post-transplant
Study Arms (1)
Cord Blood Transplant
EXPERIMENTALAdult patients with high-risk hematologic malignancies and a suitable double-unit CB graft will undergo work-up to assess protocol eligibility. CB graft selection will be based on established MSKCC guidelines. Patients will receive standard conditioning with Cy 50 mg/kg, Flu 150 mg/m2, Thio 10 mg/kg, and TBI 400 cGy according to the eligibility criteria. GVHD prophylaxis will consist of CSA and MMF starting day -3. The double-unit CB graft will be infused on day 0 per standard practice. Optimized CBT practices, will be implemented in this protocol.
Interventions
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).
The double-unit CB graft will be infused on day 0 per standard practice.
Eligibility Criteria
You may qualify if:
- 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.
- +31 more criteria
You may not qualify if:
- Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.
- Patients with persistent with CNS involvement in CSF or CNS disease 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Jakubowski, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2023
First Posted
June 1, 2023
Study Start
May 22, 2023
Primary Completion (Estimated)
May 22, 2028
Study Completion (Estimated)
May 22, 2028
Last Updated
September 8, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.