This is a pilot study which will be done in a small number of patients. The purpose of this study is to test the safety and benefit of giving a type of chemotherapy - cyclophosphamide - after the transplant to prevent graft versus host disease (GVHD) in patients with abnormal kidney function. GVHD is one of the most common complications of a stem cell transplant .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States
# GVHD (Grade II-IV) Chronic GVHD Will be Diagnosed and Graded According to the (NIH Criteria)
Chronic GVHD will be diagnosed and graded according to the (NIH criteria) treated with standard or experimental immunosuppressive therapy.
Time frame: 2 years
Disease-free Survival
DFS is defined as the minimum interval of time to relapse/recurrence, to death or to the last follow-up, from the time of transplant
Time frame: 2 years
Overall Survival
Overall survival is defined as time from transplant to death or last follow-up.
Time frame: 2 years
# Renal Insufficiency Defined as a Calculated eGFR <60 ml/Min/1.73m2. Those With a eGFR < 30 ml/Min/1.73m2 Will be Considered Ineligible.
Renal insufficiency is defined as a calculated eGFR \<60 ml/min/1.73m2. Those with a eGFR \< 30 ml/min/1.73m2 will be considered ineligible.
Time frame: 2 years
The Occurrence of Life-threatening Opportunistic Infections
will be evaluated according to the criteria established by BMT CTN , and will be correlated with the level of immune recovery.
Time frame: 2 years
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