Acute Graft Versus Host Disease
Conditions
Keywords
acute graft versus host disease, aGVHD, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, cord blood transplant, pentostatin, Nipent, deoxycoformycin
Brief summary
To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while producing treatment failure (defines as death, grade 3/4 toxicity, or progressive disease) in 40% or less of patients.
Interventions
DRUGpentostatin for injection
Sponsors
Astex Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Patients 6 months of age with grade 2 GVHD that is steroid-refractory * Must be engrafted with ANC 1000/mL, may still be transfusion dependent for platelets and PRBC * Time post stem cell infusion \< 100 days * Written informed consent * Must have adequate renal function (creatinine clearance 40 mL/min/1.73 m2) Exclusion: * Post-transplant lymphoproliferative disease * Uncontrolled infection * Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study * ATG within the previous 14 days * Other immunosuppressive agents (including monoclonal antibodies) when initiated within the previous 7 days
Countries
United States
Outcome results
None listed