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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 2, 2002
Last Updated Date	October 12, 2009
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00032773 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD
Official Title ^ICMJE	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)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Acute Graft Versus Host Disease
Intervention ^ICMJE	Drug: pentostatin for injection
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	36
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	6 Months and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00032773
Other Study ID Numbers ^ICMJE	SGI-NIP-010, NIP-010
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Astex Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Astex Pharmaceuticals
Verification Date	June 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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