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PR1-Specific Cytotoxic T-Lymphocyte Infusion With Recurrent Chronic Myelogenous Leukemia (CML) After Allogeneic Hematopoietic Transplantation

NCT00866346 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-03-04

No results posted yet for this study

Summary

Primary Objective:

To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor.

Secondary Objectives:

1. To evaluate the immunological response following PR1-CTL treatment
2. To evaluate the clinical efficacy by determining clinical, cytogenetic and molecular response rates within 6 months

Conditions

  • Chronic Myelogenous Leukemia

Interventions

BIOLOGICAL

PR1-primed lymphocyte (PR1-CTL) Infusion

Two infusions of PR1-specific T lymphocytes (donor immune cells) 60 days apart. Starting infusion dose 1 x 106 nucleated cells/kg.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Muzaffar H. Qazilbash, MD · UT MD Anderson Cancer Center

  • Richard E. Champlin, MD, BS · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2015-03-31

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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 NCT00866346 on ClinicalTrials.gov