NCT00827099

Umbilical Cord Blood (UCB) Transplant, Fludarabine, Melphalan, and Anti-thymocyte Globulin (ATG) in Treating Patients With Hematologic Cancer

Transplantation of Two Partially Matched Umbilical Cord Blood Units Following Reduced Intensity Conditioning to Enhance Engraftment and Limit Transplant-Related Mortality in Adults With Hematologic Malignancies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Northside Hospital, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving umbilical cord blood transplant together with fludarabine, melphalan, and antithymocyte globulin works in treating patients with hematologic cancer.

Detailed description

OBJECTIVES: Primary * To evaluate the 100-day transplant-related (non-relapse) mortality in patients with hematologic malignancies undergoing reduced-intensity conditioning comprising fludarabine phosphate, melphalan, and anti-thymocyte globulin followed by sequential umbilical cord blood transplantation (UCBT) from 2 partially-matched unrelated donors. Secondary * To evaluate the 12-month transplant-related (non-relapse) mortality. * To evaluate the days to neutrophil engraftment (ANC \> 500/mm³). * To evaluate the days to platelet engraftment (platelet count \> 20,000/mm³ \[unsupported\]). * To evaluate the risk of acute and chronic graft-vs-host disease. * To evaluate percent donor chimerism contribution of each cord unit. * To evaluate relapse rate. * To evaluate disease-free and overall survival. * To evaluate transfusion support needed for UCBT recipients. OUTLINE: * Conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, melphalan IV over 30-60 minutes on day -2, and anti-thymocyte globulin IV over 4-6 hours on days -4 to -2. * Transplantation: Patients undergo two sequential umbilical cord blood transplantations on day 0. * Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV continuously and then orally twice daily beginning on day -1 and continuing until day 60, followed by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil IV or orally twice daily beginning on day 0 and continuing until day 30, followed by a taper until day 60 in the absence of GVHD. After completion of study treatment, patients are followed periodically.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin	anti-thymocyte globulin
DRUG	fludarabine phosphate	fludarabine phosphate
DRUG	Melphalan	melphalan
DRUG	mycophenolate mofetil	mycophenolate mofetil
DRUG	tacrolimus	tacrolimus
PROCEDURE	umbilical cord blood transplantation	umbilical cord blood transplantation

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-01-22
• Last updated: 2012-03-23
• Results posted: 2011-08-03

Locations

1 site across 1 country: United States