NCT00032773

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2002

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2002

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2005

Completed
Last Updated

August 2, 2024

Status Verified

August 1, 2024

Enrollment Period

3.8 years

First QC Date

April 2, 2002

Last Update Submit

August 1, 2024

Conditions

Acute Graft Versus Host Disease

Keywords

acute graft versus host diseaseaGVHDallogeneic hematopoietic stem cell transplantationperipheral blood stem cell transplantationcord blood transplantpentostatinNipentdeoxycoformycin

Interventions

pentostatin for injectionDRUG

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, United States

Location

MeSH Terms

Interventions

PentostatinInjections

Intervention Hierarchy (Ancestors)

CoformycinFormycinsPyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2002

First Posted

April 4, 2002

Study Start

January 30, 2002

Primary Completion

November 3, 2005

Study Completion

November 3, 2005

Last Updated

August 2, 2024

Record last verified: 2024-08

Locations

US(1)