Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer

Completed · Phase 2

Conditions studied: Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Secondary Myelofibrosis

In brief

RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain 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 and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer.

Key facts

Study ID

NCT00611351

Run by

University of Nebraska

People needed

5

Starts

2005-06-07

Expected to finish

2008-09-17

Last updated by the study team

2023-10-23

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically confirmed diagnosis of 1 of the following:
• Acute myeloid leukemia
• Acute lymphocytic leukemia
• Chronic myelogenous leukemia beyond first chronic phase (i.e., 2nd chronic phase, accelerated phase, or blast crisis)
• Multiple myeloma
• Myelodysplastic syndromes
• Malignant lymphoma
• Myelofibrosis
• Requirement for myeloablative conditioning regimen confirmed by attending physician
• Available donor must meet the following criteria:
• HLA phenotypically identical unrelated donor by low, intermediate, or high resolution for HLA class I antigens, and by high resolution for HLA class II antigens
• Matched at the A, B, and DRβ1 loci
• Single HLA-A or HLA-B antigen mismatch allowed
• Meets all National Marrow Donor Program or foreign registry criteria for allogeneic bone marrow/stem cell donors
• Peripheral blood stem cells are the preferred product on this study but bone marrow is allowed
• Karnofsky performance status 70-100%
• DLCO ≥ 50% predicted
• LVEF ≥ 45%
• Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 65 mL/min
• Serum total bilirubin ≤ 2.0 mg/dL
• Fertile patients must use effective contraception

You may not qualify if…

• No active uncontrolled infection
• Not pregnant or nursing/negative pregnancy test
• No HIV infection
• No chronic active hepatitis B or C or evidence of cirrhosis on liver biopsy

Where it is running

• Unversity of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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