Actively Recruiting
Cord Blood Transplantation in Children and Young Adults With Hematologic Malignancies
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-14
71
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating cord blood transplantation (CBT) as a treatment for children and young adults up to 26 years old with various blood cancers, including acute myelogenous leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, and lymphomas. The study focuses on whether CBT used as a first or second transplant can be effective, especially for those who lack matched donors within a short time frame. Participants include those in remission or with relapsed/refractory disease, and the study is sponsored by Memorial Sloan Kettering Cancer Center. The study involves two groups: one with high-risk disease and no prior transplant, and another with very high-risk disease including patients who had a prior transplant or relapsed disease. Treatments include minimally manipulated unrelated cord blood units along with preparative therapies such as total body irradiation, chemotherapy drugs like cyclophosphamide, fludarabine, clofarabine, busulfan, thiotepa, and immunosuppressants including tacrolimus, mycophenolate mofetil, and cyclosporine. The second transplant is scheduled at least four months after the first when applicable. Participants will undergo regular evaluations including bone marrow tests for disease status, organ function assessments, and monitoring of immune response and side effects. The main outcome measured is disease-free survival one year after transplantation. The study requires adherence to treatment protocols, long-term follow-up, and safety monitoring, lasting until at least April 2030. Participants will have various clinical and laboratory assessments throughout the study to monitor health and treatment effects.
CONDITIONS
Brief Title
Cord Blood Transplantation in Children and Young Adults With Blood Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 26 years or younger at consent
- Diagnosed with acute myelogenous leukemia, acute lymphoblastic leukemia, other acute leukemias, myelodysplastic syndrome, non-Hodgkin lymphoma, or Hodgkin lymphoma
- High-risk or very high-risk disease status as defined by remission status and prior transplant history
- No suitably matched related or unrelated donor available within 4 weeks (for Cohort 1)
- Complete remission with bone marrow blasts less than 5% or relapsed/refractory disease with up to 30% blasts
- Adequate organ function including liver, lung, heart, and kidney
- Karnofsky or Lansky performance score of 70% or higher
- Negative pregnancy test and use of contraception if of childbearing potential
- Ability to comply with treatment, supportive care, and long-term follow-up
You will not qualify if you...
- Inadequate performance status or organ function
- Active central nervous system leukemic involvement
- Active and uncontrolled infection at time of transplant
- HIV infection or seropositivity for HTLV-1
- Pregnancy or breastfeeding
- Inability to give informed consent or comply with study procedures
- Any condition or lab result that may affect patient safety or study outcome
- Allogeneic transplant within the preceding 4 months (for very high-risk cohort)
- Recent use of checkpoint inhibitors within 12 months (eligibility discussed with study PI)
- Untreated or active hepatitis B or C infection without undetectable viral load or cure
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants receive a conditioning regimen including chemotherapy and total body irradiation followed by a cord blood transplant. Immunosuppressive drugs are administered to prevent rejection.
Multiple visits during treatment period including conditioning and transplant
Duration - Up to 1 year
Participants are monitored for disease-free survival and potential complications after transplant.
Regular follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
Research Team
A
Andromachi Scaradavou, MD
J
Jaap Jan Boelens, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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