Cord Blood Transplant for Adult Blood Cancers
This study is looking at how well a specific cord blood transplant (CBT) approach works for adults aged 21 to 65 with certain blood cancers like Acute Myelogenous Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CML), Myelodysplastic Syndromes (MDS), and Myeloproliferative Disorder. You might be eligible if you have AML in complete first remission with a high risk of relapse. The treatment involves conditioning chemotherapy (Cyclophosphamide, Fludarabine, Thiotepa) and Total Body Irradiation (TBI), followed by a cord blood graft. Researchers will track your overall survival one year after the transplant, as well as side effects, disease relapse, GVHD (Graft-versus-Host Disease), and how your immune system recovers. The study's current status is unclear.
- Study design
- This is an interventional study planning to enroll 54 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for overall survival, measured at 1 year post transplant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05884333
Cord Blood Transplant in Adults With Blood Cancers
Recruiting
PHASE2Ages 21–65InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~54 participants
Updated 2025-09-08 on ClinicalTrials.gov
What's tested:Conditioning ChemotherapyCord blood graft
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over 1 year post transplant
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Ann Jakubowski, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
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.
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.
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
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.
What this trial measures
- Overall survival (OS)1 year post transplant