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

Acute Graft Versus Host Disease Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00032773
• Other study ID #: SGI-NIP-010
• Secondary ID: NIP-010
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 30, 2002
• Est. completion date: November 3, 2005

Study information

• Verified date: October 2020
• Source: Astex Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: November 3, 2005
• Est. primary completion date: November 3, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• pentostatin for injection

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Astex Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States,