Overview

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).