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

This study is currently recruiting patients.

Sponsored by: SuperGen
Information provided by: SuperGen

Purpose

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.

Condition Treatment or Intervention Phase
Acute Graft Versus Host Disease
 Drug: pentostatin for injection
Phase I
Phase II

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Official Title: A sequentially adaptive, open label, dose-finding, Phase I/II trial of pentostatin in the treatment of steroid-refractory acute graft versus host disease (aGvHD)

Eligibility

Ages Eligible for Study:  6 Months and above,  Genders Eligible for Study:  Both

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.

Location and Contact Information

Emel Bayar, MD      925-560-0100  Ext. 404    EBayar@supergen.com

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

More Information

Study ID Numbers:  SGI-NIP-010; NIP-010
Record last reviewed:  April 2002
Last Updated:  October 13, 2004
Record first received:  April 2, 2002
ClinicalTrials.gov Identifier:  NCT00032773
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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