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

This study has been terminated.
Sponsor:
Information provided by:
Astex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00032773
First received: April 2, 2002
Last updated: October 12, 2009
Last verified: June 2005

April 2, 2002
October 12, 2009
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Complete list of historical versions of study NCT00032773 on ClinicalTrials.gov Archive Site
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Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD
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)

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.

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Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Graft Versus Host Disease
Drug: pentostatin for injection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
36
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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.
Both
6 Months and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00032773
SGI-NIP-010, NIP-010
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Astex Pharmaceuticals
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Astex Pharmaceuticals
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP