TerminatedPhase 1/2

Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD

United States36 participantsStarted 2002-01-30

Plain-language 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.

Who can participate

Age range6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Trial details

NCT IDNCT00032773

SponsorAstex Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-11-03

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