RecruitingPhase 2NCT05884333

Cord Blood Transplant in Adults With Blood Cancers

Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

54 participants

Start Date

May 22, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myelogenous Leukemia (AML)

Summary

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.

Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating cord blood transplants in adults with blood cancers including leukemia, lymphoma, and related conditions. Cord blood (stem cells from umbilical cords) may offer a transplant option for patients without a matched donor. **You may be eligible if...** - You have acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome, chronic myeloid leukemia, Hodgkin or non-Hodgkin lymphoma, or a related blood cancer - Your cancer is in remission or at a stage where a bone marrow transplant is recommended - You meet organ function requirements for transplant - You are in good enough health to undergo the transplant process **You may NOT be eligible if...** - Your cancer is not in a transplant-eligible state - You have severe organ problems (heart, liver, kidneys, lungs) that make transplant unsafe - You have uncontrolled infections - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGConditioning Chemotherapy

Conditioning: Cyclophosphamide (CY) 50 mg/kg x1 (day -6), Fludarabine (FLU) 30 mg/m2 x5 (days -6 to -2), Thiotepa (THIO) 5 mg/kg x2 (days -5 \& -4), Total Body Irradiation (TBI) 200 cGy x2 (days -2 \& -1). GVHD prophylaxis: Cyclosporine (CSA) 3 mg/kg q12 hours \& Mycophenolate Mofetil (MMF) 15 mg/kg q8 hours (starting IV day -3).

BIOLOGICALCord blood graft

The double-unit CB graft will be infused on day 0 per standard practice.

Locations(1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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NCT05884333

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