Actively Recruiting
Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-09-08
54
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with high-risk blood cancers who undergo cord blood transplants (CBT) using an optimized practice developed by Memorial Sloan Kettering Cancer Center. This approach standardizes patient evaluation, conditioning treatment, stem cell amounts, and follow-up care. The study aims to collect information on outcomes such as side effects, disease relapse, graft-versus-host disease (GVHD), and immune system recovery after CBT. Participants receive conditioning chemotherapy including cyclophosphamide, fludarabine, thiotepa, and total body irradiation before receiving a double-unit cord blood graft infusion on day 0. GVHD prevention involves cyclosporine and mycophenolate mofetil starting three days before transplant. Patients are selected based on established guidelines for graft matching and cell doses. Optimized transplant practices are followed throughout the treatment. During the study, participants will be monitored for overall survival one year after transplant and for neutrophil engraftment up to 45 days post-transplant. Researchers will assess side effects, disease relapse, GVHD, and immune recovery through regular evaluations. The total participation duration includes pre-transplant work-up, transplant, and post-transplant follow-up extending at least one year to measure outcomes.
CONDITIONS
Brief Title
Cord Blood Transplant in Adults With Blood Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 21 to 65 years
- Diagnosed with high-risk acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL) in remission or other acute leukemias with less than 5% blasts
- Diagnosed with myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD) with specific risk scores or cytopenias
- Diagnosed with high-risk non-Hodgkin's lymphoma (NHL) in remission
- Karnofsky performance score of 80% or higher
- Adequate organ function including creatinine clearance over 70 ml/min and left ventricular ejection fraction over 50%
- Hematopoietic Cell Transplantation Comorbidity Index of 5 or less
- Availability of two suitable cord blood units meeting HLA match and cell dose criteria
- Ability to provide informed consent and comply with treatment and follow-up protocols
You will not qualify if you...
- Diagnosis of myelofibrosis or malignancy with moderate to severe bone marrow fibrosis
- Persistent central nervous system involvement or disease at screening
- Use of checkpoint inhibitors in the last 12 months
- Two prior stem cell transplants of any kind
- One prior autologous stem cell transplant within the last 12 months
- Prior allogeneic transplant
- Prior radiation therapy preventing safe total body irradiation
- Active uncontrolled infection at transplant
- HIV infection or HTLV-1 seropositivity
- Inadequate performance status or organ function
- Pregnancy or breastfeeding
- Inability to provide informed consent or comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days (Day -6 to Day 0)
Participants receive conditioning chemotherapy including Cyclophosphamide, Fludarabine, Thiotepa, and Total Body Irradiation to prepare for the cord blood transplant. GVHD prophylaxis medications start during this period.
Daily visits for 7 days
Duration - 1 day (Day 0)
Participants undergo infusion of the double-unit cord blood graft on Day 0 according to standard practice.
1 visit (in-person)
Duration - Up to 1 year post transplant
Participants are monitored for engraftment, overall survival, and potential complications including graft-versus-host disease.
Regular follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
A
Ann Jakubowski, MD, PhD
A
Andromach Scaradavou, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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