Cord Blood Transplant in Adults With Blood Cancers

In brief

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.

Key facts

Study ID: NCT05884333
Run by: Memorial Sloan Kettering Cancer Center
People needed: 54
Starts: 2023-05-22
Expected to finish: 2028-05-22
Last updated by the study team: 2025-09-08

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
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.

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.

Where it is running

Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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