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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00032773
Recruitment Status : Terminated
First Posted : April 4, 2002
Last Update Posted : October 14, 2009
Information provided by:
Astex Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Graft Versus Host Disease Drug: pentostatin for injection Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00032773

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States
Sponsors and Collaborators
Astex Pharmaceuticals Identifier: NCT00032773     History of Changes
Other Study ID Numbers: SGI-NIP-010
First Posted: April 4, 2002    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: June 2005

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
Adenosine Deaminase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action