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Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT

NCT00506922 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-04-28

Study results available
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Summary

Primary Objective:

1\. To determine efficacy of escalating doses of pentostatin in combination with tacrolimus and methotrexate for the prevention of acute graft-versus-host disease (GVHD) in the context of unrelated donor and one antigen mismatched related donor transplantation.

Secondary Objectives:

1. To determine safety of escalating doses of pentostatin in combination with tacrolimus and methotrexate.
2. To reduce the incidence of acute GVHD following transplants with unrelated donor to 40%.
3. To document blood levels of tacrolimus when combined with pentostatin.

Conditions

Interventions

DRUG

Pentostatin

Given intravenously on days +8, +15, +22 and +30 post transplant: Group 2 - Pentostatin 0.5 mg/m\^2 Group 3 - Pentostatin 1 mg/m\^2 Group 4 - Pentostatin 1.5 mg/m\^2 Group 5 - Pentostatin 2 mg/m\^2

DRUG

Tacrolimus

Given intravenously from day -2, and will be switched to oral dosing when tolerated.

DRUG

Methotrexate

Given intravenously on days +1, +3, and +6 at the dose of 5 mg/m2.

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Marcos de Lima, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00506922 on ClinicalTrials.gov