Clinical Trials Directory

Trials / Completed

CompletedNCT01177371

High-Dose Busulfan and High-Dose Cyclophosphamide Followed By Donor Bone Marrow Transplant in Treating Patients With Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Recurrent Hodgkin or Non-Hodgkin Lymphoma

High-dose Busulfan, High-dose Cyclophosphamide, and Allogeneic Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndromes, Multiple Myeloma and Lymphoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Case Comprehensive Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

RATIONALE: Giving high doses of chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor bone marrow transplant helps stop the growth of cancer cells. It may also 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 cyclosporine, methylprednisolone, and methotrexate after transplant may stop this from happening. PURPOSE: This clinical trial studies high-dose busulfan and high-dose cyclophosphamide followed by donor bone marrow transplant in treating patients with leukemia, myelodysplastic syndrome, multiple myeloma, or recurrent Hodgkin or Non-Hodgkin lymphoma.

Detailed description

OBJECTIVES: I. To determine the toxicity and efficacy of the high-dose chemotherapy regimen which employs busulfan, cyclophosphamide, and allogeneic bone marrow transplantation. II. To ascertain feasibility (safety) and efficacy of the use of intensive chemotherapy regimen (busulfan and cyclophosphamide) followed by allogeneic bone marrow transplantation in patients with leukemia, myelodysplastic syndromes, multiple myeloma, and lymphoma. OUTLINE: HIGH-DOSE CHEMOTHERAPY: Patients receive oral busulfan every 6 hours on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 and -3, or -4 to -2 . TRANSPLANTATION: Patients undergo allogeneic bone marrow transplant IV over 2-3 hours on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine IV over 6 hours on day -1, over 10 hours twice daily on days 0-20, and then orally every 12 hours beginning on day 21 and continuing for 12 months with taper at 9 months. Patients also receive methylprednisolone IV or orally beginning on day 8 and continuing for 7 months with taper at 4 months. Some patients may also receive methotrexate IV on days 1, 3 and 6 . After completion of study treatment, patients are followed up periodically.

Conditions

Interventions

TypeNameDescription
DRUGbusulfanGiven orally
DRUGcyclophosphamideGiven IV
PROCEDUREallogeneic bone marrow transplantationPatients undergo allogeneic bone marrow transplant IV over 2-3 hours on day 0.
DRUGmethylprednisoloneGiven IV or orally
DRUGmethotrexateGiven IV
DRUGcyclosporineGiven IV or orally

Timeline

Start date
1988-03-01
Primary completion
2000-02-01
Completion
2010-02-01
First posted
2010-08-09
Last updated
2010-08-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01177371. Inclusion in this directory is not an endorsement.