This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
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   (Child, Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Identifier: NCT00032773     History of Changes
Other Study ID Numbers: SGI-NIP-010
Study First Received: April 2, 2002
Last Updated: October 12, 2009

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 processed this record on June 23, 2017