NCT00304018

Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer

Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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. OUTLINE: This is a pilot study. * Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3, busulfan IV over 2 hours 4 times daily on days -7 and -4, etoposide IV over 4 hours on day -3, and anti-thymocyte globulin IV over 6 hours on days -2 and -1. * Donor umbilical cord blood transplantation (UCBT): Patients undergo donor UCBT on day 0. Beginning on day 7, patients receive sargramostim (GM-CSF) IV or subcutaneously once daily until blood counts recover. * Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously over 24 hours or orally twice daily beginning on day -2 and continuing until day 180 followed by a taper. Patients also receive oral prednisone twice daily on days 13-50 and then once daily on days 50-60, followed by a rapid taper. After completion of study treatment, patients are followed periodically for approximately 2 years. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Conditions

• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin
BIOLOGICAL	sargramostim
DRUG	busulfan
DRUG	etoposide
DRUG	fludarabine phosphate
DRUG	prednisone
DRUG	tacrolimus
PROCEDURE	allogeneic hematopoietic stem cell transplantation
PROCEDURE	umbilical cord blood transplantation

Timeline

• Start date: 2002-10-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2006-03-17
• Last updated: 2013-08-14

Locations

1 site across 1 country: United States