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Dose-finding study using pentostatin for injection in the treatment of steroid-refractory aGvHD



Dose-finding study using pentostatin for injection in the treatment of steroid-refractory aGvHD

For Condition: Acute Graft Versus Host Disease
Status: Recruiting
Sponsor(s): SuperGen ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 6 Months/
Genders: Both
Protocol Entry 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.
Total Enrollment: 36

Location and Contact Information:

MD Anderson Cancer Center *Recruiting*
Houston,  Texas, 
United States
Recruiting  


Additional Information:
Study ID Numbers:
  SGI-NIP-010;  NIP-010
Study Start Date: 
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032773

Other Acute Graft Versus Host Disease Studies:
1. Dose-finding study using pentostatin for injection in the treatment of steroid-refractory aGvHD

2. Phase I/II trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD

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