Cord Blood Transplant in Adults With Blood Cancers

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05884333
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myelogenous Leukemia (AML)
  • Chronic Myelogenous Leukemia (CML)
  • Myelodysplastic Syndromes (MDS)
  • Myeloproliferative Disorder
  • Non-Hodgkin's Lymphoma

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Conditioning Chemotherapy — DRUG
    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).
  • Cord blood graft — BIOLOGICAL
    The double-unit CB graft will be infused on day 0 per standard practice.

Study Details

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.

Key Dates

Start date
May 22, 2023
Status verified
Sep 2025
Primary completion
May 22, 2028
Completion
May 22, 2028

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cord Blood Transplant
    Adult patients with high-risk hematologic malignancies and a suitable double-unit CB graft will undergo work-up to assess protocol eligibility. CB graft selection will be based on established MSKCC guidelines. Patients will receive standard conditioning with Cy 50 mg/kg, Flu 150 mg/m2, Thio 10 mg/kg, and TBI 400 cGy according to the eligibility criteria. GVHD prophylaxis will consist of CSA and MMF starting day -3. The double-unit CB graft will be infused on day 0 per standard practice. Optimized CBT practices, will be implemented in this protocol.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: 1 year post transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Ann Jakubowski, MD, PhD
[email protected]
646-608-3782
Andromach Scaradavou, MD
212-639-3267

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