New cord blood transplant recipe aims to beat tough blood cancers
NCT ID NCT05884333
First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This study tests a standardized, optimized approach to cord blood transplantation for adults with high-risk blood cancers like leukemia and lymphoma. The method includes specific chemotherapy, radiation, and stem cell dosing, followed by careful monitoring. Researchers hope to improve survival and reduce side effects like graft-versus-host disease. About 54 participants will be enrolled at Memorial Sloan Kettering.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cord blood stem cells (double-unit graft) with conditioning chemotherapy (cyclophosphamide, fludarabine, thiotepa) and total body irradiation
- What this could lead to
- If successful, this could improve survival and reduce complications for adults with high-risk blood cancers who need a cord blood transplant.
- What could go wrong
- This is a small, single-center phase 2 study, so results may not apply broadly. Cord blood transplants carry risks like infection, graft failure, and graft-versus-host disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
Contact Email: •••••@•••••
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