Fludarabine, Cyclophosphamide, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing a Donor Umbilical Cord Blood Transplant for Hematologic Cancer
NCT00255684 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2016-11-03
Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy before a donor umbilical cord blood 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 cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by cyclosporine and mycophenolate mofetil works in treating patients who are undergoing a donor umbilical cord blood transplant for hematologic cancer.
Conditions
- Chronic Myeloproliferative Disorders
- Graft Versus Host Disease
- Leukemia
- Lymphoma
- Multiple Myeloma
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
Interventions
- BIOLOGICAL
-
graft-versus-tumor induction therapy
- DRUG
- DRUG
-
cyclosporine
- DRUG
-
fludarabine phosphate
- DRUG
-
mycophenolate mofetil
- PROCEDURE
-
umbilical cord blood transplantation
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
University of Rochester
lead OTHER
Principal Investigators
-
Gordon L. Phillips, MD · James P. Wilmot Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-12-31
- Primary Completion
- 2013-03-31
- Completion
- 2016-06-30
Countries
- United States
Study Locations
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