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TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients

NCT00415909 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2014-06-30

Study results available
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Summary

Objectives:

* To determine the response rate and duration of response with combination of TALL-104 cells and imatinib mesylate (IM) therapy in patients with chronic myelogenous leukemia in chronic phase, that have not achieved, or have lost, adequate response to IM.
* To determine the toxicity of the combination of TALL-104 cells and IM therapy in this patient population.

Conditions

  • Chronic Myelogenous Leukemia

Interventions

DRUG

Imatinib Mesylate (IM)

IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.

DRUG

TALL-104 cells

TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells

Sponsors & Collaborators

  • Abiogen Pharma

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jorge E. Cortes, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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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 NCT00415909 on ClinicalTrials.gov