Trials / Active Not Recruiting

Active Not RecruitingNCT00544115

Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders

A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Unrelated Donors in Patients With Advanced Hematologic Malignancies and Hematological Disorders

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 260 (actual)

Sponsor: City of Hope Medical Center · Academic / Other
Sex: All
Age: 0 Years – 120 Years
Healthy volunteers: Not accepted

Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem 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 tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, and sirolimus before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works in treating patients with advanced hematologic cancer or other disorders.

Detailed description

OBJECTIVES: Primary * To evaluate hematopoietic recovery, using neutrophil and platelet engraftment as the primary criterion, in patients with advanced hematologic malignancies or other disorders undergoing allogeneic peripheral blood stem cell (PBSC) transplantation from matched unrelated donors. * To evaluate the incidence of acute and chronic graft-versus-host-disease (GVHD) in patients undergoing allogeneic PBSC transplantation from matched unrelated donors. Secondary * To evaluate the impact of HLA class I and class II allele-matching on the incidence of GVHD and on the survival outcome of these patients. * To evaluate overall survival, disease-free survival, and relapse in these patients. OUTLINE: Patients are stratified according to type of conditioning regimen (myeloablative vs reduced-intensity myeloablative). Patients are assigned to a conditioning regimen according to diagnosis, age, disease status, prior radiotherapy, and prior autologous stem cell transplantation. * Conditioning regimen: * Regimen I: Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1. * Regimen II: Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2. * Regimen III: Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3. * Regimen IV: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. * Regimen V: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0. * Regimen VI: Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2. * Allogeneic peripheral blood stem cell (PBSC) transplantation: All patients undergo allogeneic PBSC transplantation on day 0. * Graft-versus-host disease (GVHD) prophylaxis: Patients receive one of the following GVHD prophylaxis regimens: * Regimen A: Patients receive tacrolimus IV or orally on days -1 to 180 and methotrexate IV on days 1, 3, 6, and 11. * Regimen B: Patients receive cyclosporine IV or orally twice daily on days -1 to 180, mycophenolate mofetil IV over 2 hours or orally twice daily on days 0-27, and methotrexate IV on days 1, 3, and 6. * Regimen C: Patients receive tacrolimus IV continuously or orally, and oral sirolimus beginning on day -3. Patients also receive methotrexate IV on days 1, 3, and 6. After completion of study therapy, patients are followed periodically.

Conditions

Interventions

Type	Name	Description
DRUG	busulfan
DRUG	cyclophosphamide
DRUG	cyclosporine
DRUG	etoposide
DRUG	fludarabine phosphate
DRUG	melphalan
DRUG	methotrexate
DRUG	mycophenolate mofetil
DRUG	sirolimus
DRUG	tacrolimus
PROCEDURE	allogeneic hematopoietic stem cell transplantation
PROCEDURE	peripheral blood stem cell transplantation
RADIATION	total-body irradiation

Timeline

Start date: 2001-10-16
Primary completion: 2007-03-13
Completion: 2026-04-02
First posted: 2007-10-16
Last updated: 2025-06-10
Results posted: 2023-05-10

Source: ClinicalTrials.gov record NCT00544115. Inclusion in this directory is not an endorsement.