A Phase 2 interventional study of cyclophosphamide and cyclosporine in Leukemia, Lymphoma and Myelodysplastic Syndromes, sponsored by Fred Hutchinson Cancer Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-05-07.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
RATIONALE: Giving total-body irradiation and chemotherapy, such as cyclophosphamide, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal 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 immunosuppressive therapy before or after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving total-body irradiation together with cyclophosphamide works in treating patients who are undergoing donor stem cell transplant for hematologic cancer and other diseases.
OBJECTIVES:
Primary
Secondary
OUTLINE:
NOTE: *Patients undergo frequent blood sampling after completion of the first cyclophosphamide infusion for pharmacokinetic studies in order to determine the dose for the second cyclophosphamide infusion.
After completion of study treatment, patients are followed periodically for at least 200 days.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.
This study's planned enrollment of 50 is above the median of 38 across 4,268 interventional studies indexed under Leukemia.
Browse Leukemia studies →Fred Hutchinson Cancer Center is the lead sponsor of 546 studies on the registry; 79 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 46 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of a hematologic cancer or other disease that is unlikely to respond to conventional treatment, including any of the following:
Must have an HLA-matched donor available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Non-relapse mortality (NRM) at 200 days
Overall survival
Relapse rate
Sinusoidal obstruction syndrome (SOS)
Acute renal failure
Respiratory failure
Cause of death
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cyclophosphamide
Fred Hutchinson Cancer Center →