TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Abiogen Pharma
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

1. Patients with CML in chronic phase who have failed to achieve or have lost an adequate response to IM. For the purpose of this trial this will be defined as a lack of any cytogenetic response after 6 months of therapy or lack of major cytogenetic response after 12 months of therapy with IM. Patients that have lost their major or complete cytogenetic response will also be eligible. Patients who show a sustained increase in breakpoint cluster region gene (BCR)-Abelson gene (ABL)/ABL [BCR-ABL/ABL] ratio of >/= 1-log confirmed in at least two consecutive Polymerase Chain Reaction (PCR) analyses (at least one month apart from each other) will also be eligible.

2. *continued from above: Patients with stable molecular response defined as 2 consecutive PCR-positive results (no more than 1/2 log improvement) will also be eligible. Patients must be taking stable dose of IM for at least 3 months before study enrollment, and recovered from all toxicities related to IM, to grade 0-1.

3. Patients should be in complete or partial hematological remission, including white blood count (WBC)

4. Eastern Cooperative Oncology Group (ECOG) scale performance status of 2 or less.

5. Age greater than 18 years of age since disease is extremely rare in younger age groups.

6. Adequate liver (total bilirubin of less than 2 times and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) of less than 2 times upper limits of normal), and renal function (creatinine of less than 2 times upper limit of normal).

7. Signed informed consent form.

8. Negative pregnancy test in women of childbearing age.

9. Negative hepatitis B and C screening blood tests.

Exclusion Criteria:

1. Serious intercurrent medical illnesses or active infections requiring parenteral antibiotics that would interfere with the ability of the patient to carry out the treatment program.

2. Female patients who are pregnant or breast-feeding.

3. Patients taking steroids, or those anticipated to receive steroids during the trial therapy.

4. Prior bone marrow transplant.

5. Known positivity for human immunodeficiency virus (HIV).