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

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

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 Intervention Phase
Acute Graft Versus Host Disease
Drug: pentostatin for injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Astex Pharmaceuticals:

Estimated Enrollment: 36

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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


  • 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00032773

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States
Sponsors and Collaborators
Astex Pharmaceuticals
  More Information

No publications provided Identifier: NCT00032773     History of Changes
Other Study ID Numbers: SGI-NIP-010, NIP-010
Study First Received: April 2, 2002
Last Updated: October 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Astex Pharmaceuticals:
acute graft versus host disease
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
cord blood transplant

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adenosine Deaminase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 15, 2014