TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients
Condition: Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Imatinib Mesylate (IM); TALL-104 cells
Intervention description: IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.; 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
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Chronic Myelogenous Leukemia; CML; Imatinib; Gleevec; TALL-104

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.
    

Eligibility 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) </=20 x 10(9)/L, and platelets </= 600 x 10(9)/L.

          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).