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

This study has been terminated.

First Received on April 2, 2002. Last Updated on October 12, 2009 History of Changes

Sponsor:	Astex Pharmaceuticals
Information provided by:	Astex Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00032773

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

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:

Drug Information available for: Pentostatin

U.S. FDA Resources

Further study details as provided by Astex Pharmaceuticals:

Estimated Enrollment:

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032773

Locations

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

Sponsors and Collaborators

Astex Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov 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
aGVHD
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation

cord blood transplant
pentostatin
Nipent
deoxycoformycin

Additional relevant MeSH terms:

Graft vs Host Disease
Immune System Diseases
Pentostatin
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Adenosine Deaminase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012