NCT00054327

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 55 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 and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well giving chemotherapy with or without radiation therapy followed by donor stem cell transplant works in treating patients with hematologic cancer.

Detailed description

OBJECTIVES: * Determine a standard approach to hematopoietic stem cell transplantation with matched unrelated donors in patients with hematologic malignancies. * Determine the toxicity of this regimen in these patients. * Determine the relapse rate and survival rate in patients treated with this regimen. * Correlate incidence and severity of graft-versus-host disease with relapse and survival in patients treated with this regimen. OUTLINE: Patients receive 1 of the following preparative regimens: * Regimen A: Patients receive cytarabine IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1. * Regimen B-1: Patients receive cyclophosphamide IV and TBI as in regimen A. * Regimen B-2: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1. * Regimen B-3: Patients receive TBI on days -7 to -5. Patients receive cyclophosphamide IV over on days -4 to -3. * Regimen C: Patients receive oral busulfan 4 times daily on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 to -2. * Regimen D: Patients receive TBI on days -6 to -4. Patients receive etoposide infusion on day -3. All patients undergo stem cell transplantation from a matched, unrelated donor on day 0. Patients are followed weekly for 100 days, at 6 months, and then every 6 months for 2.5 years. PROJECTED ACCRUAL: 50

Conditions

• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases

Interventions

Type	Name	Description
DRUG	busulfan	Given orally 1mg/kg/dose (or 40mg/m2/dose for young children)
DRUG	cyclophosphamide	Given IV
DRUG	cytarabine	Given IV
RADIATION	radiation therapy	Patients undergo total body irradiation
DRUG	Etoposide	infusion
PROCEDURE	Stem Cell Transfusion

Timeline

• Start date: 2000-11-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2003-02-06
• Last updated: 2013-07-24
• Results posted: 2013-07-24

Locations

1 site across 1 country: United States