Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies
Study Overview
Brief Summary
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and etoposide, before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and tacrolimus and prednisone after transplant may stop this from happening.
PURPOSE: This phase I trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.
Detailed Description
OBJECTIVES:
Primary
- Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of > 80% engraftment rate at day 100 post-transplant and ≤ 50% transplant-related mortality.
Secondary
- Determine the toxicity of a myeloablative preparative regimen comprising busulfan, fludarabine, and etoposide prior to UCBT in these patients.
- Determine the neutrophil and platelet recovery in patients treated with this regimen.
- Determine the event-free and overall survival of patients treated with this regimen.
- Evaluate lineage-specific chimerism after UCBT and assess the contribution of each individual cord blood unit to post-transplantation hematopoiesis in these patients.
- Determine the incidence, severity, and timing of acute and chronic graft-vs-host disease in patients treated with this regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
cord blood transplant
Intervention: etoposide (Drug)
cord blood transplant
Intervention: anti-thymocyte globulin (Biological)
cord blood transplant
Intervention: sargramostim (Biological)
cord blood transplant
Intervention: busulfan (Drug)
cord blood transplant
Intervention: fludarabine phosphate (Drug)
cord blood transplant
Intervention: prednisone (Drug)
cord blood transplant
Intervention: tacrolimus (Drug)
cord blood transplant
Intervention: allogeneic hematopoietic stem cell transplantation (Procedure)
cord blood transplant
Intervention: umbilical cord blood transplantation (Procedure)
Outcomes
Primary Outcomes
Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies
Time Frame: up to 24 months post-transplant
Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of \> 80% engraftment rate at day 100 post-transplant and ≤ 50% transplant-related mortality.
Secondary Outcomes
No secondary outcomes reported