Cyclophosphamide and/or Mycophenolate Mofetil With or Without Tacrolimus in Treating Patients Who Are Undergoing a Donor Bone Marrow or Peripheral Stem Cell Transplant for Hematologic Cancer
NCT00255710 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2010-03-17
Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system 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 cyclophosphamide, mycophenolate mofetil, and tacrolimus after transplant may stop this from happening.
PURPOSE: This phase I trial is studying cyclophosphamide and/or mycophenolate mofetil with or without tacrolimus to see which is the best regimen in treating patients who are undergoing a donor bone marrow or stem cell transplant for hematologic cancer.
Conditions
- Chronic Myeloproliferative Disorders
- Graft Versus Host Disease
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Diseases
Interventions
- BIOLOGICAL
- DRUG
- DRUG
-
fludarabine phosphate
- DRUG
-
mycophenolate mofetil
- DRUG
- PROCEDURE
-
allogeneic bone marrow transplantation
- PROCEDURE
-
peripheral blood stem cell transplantation
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
lead OTHER
Principal Investigators
-
Carol A. Huff, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Design
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-07-31
Countries
- United States
Study Locations
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