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TerminatedNCT00032773Updated Aug 2, 2024

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

A Phase 1/2 interventional study of pentostatin for injection in Acute Graft Versus Host Disease, sponsored by Astex Pharmaceuticals, Inc.. Terminated at 1 site in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by Astex Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
6 Months and older
Sex
All
01

Study 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.

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Conditions studied

  • Acute Graft Versus Host Disease

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Keywords

  • acute graft versus host disease
  • aGVHD
  • allogeneic hematopoietic stem cell transplantation
  • peripheral blood stem cell transplantation
  • cord blood transplant
  • pentostatin
  • Nipent
  • deoxycoformycin
03

In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's enrollment of 36 is close to the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.

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Lead sponsor

Astex Pharmaceuticals, Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 6 (46%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants

Interventions

  • Drugpentostatin for injection
06

Study locations

1 site
  • MD Anderson Cancer Center
    Houston, Texas, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00032773
Lead sponsor
Astex Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Apr 4, 2002
Start date
Jan 30, 2002
Primary completion
Nov 3, 2005
Completion
Nov 3, 2005
Last update
Aug 2, 2024
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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