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

Astex Pharmaceuticals

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Acute Graft Versus Host Disease

Treatments

Drug: pentostatin for injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00032773

SGI-NIP-010

NIP-010

Details and patient eligibility

About

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.

Sex

All

Ages

6+ months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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