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Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia-Lymphoma, Adult T-Cell

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Myeloid Leukemia

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Chronic Myeloid Leukemia

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Chronic Myeloproliferative Disorders

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Amino Acids

Imatinib Mesylate

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Tyrosine

TALL-104 cells and imatinib mesylate (IM) therapy

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

Imatinib Mesylate (IM)

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

TALL-104 cells

Jorge E. Cortes, MD

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.

Imatinib mesylate is designed to block the enzyme that is believed to be responsible for starting the type of leukemia patient has. TALL-104 cells are cells of the immune system that have been obtained from a patient with leukemia and then processed in the laboratory to try to make them able to kill leukemia cells.

If found to be eligible to take part in this study, patient will continue receiving imatinib mesylate by mouth at the same schedule and dose patient had been receiving before entering the study. Patient will receive TALL-104 cells through a needle in their vein over 1 hour on Days 1-4, and then again on Days 7, 10, 14, 17, and 21 of the cycle. The cycle will last 28 days.

Blood (about 1 tablespoon) will be drawn every week for the first 4 weeks, then every 2-4 weeks for 2 months, then every 4-6 weeks until 6 months, and then every 3-6 months for routine tests and to check for any effect on organs.

Patient will have follow-up visits at 1 month, 3 months, 6 months, and at least annually for 2 years, and then at least every 5 years from then on for the rest of your life. Blood (about 1 teaspoon) will be drawn to check the status of the disease. An additional 1 tablespoon will also be collected and stored to be analyzed in case unexpected side effects occur after receiving therapy. If patient experiences certain side effects, more blood may need to be drawn and more tests performed based on the side effects experienced.

Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients

Phase II "Proof of Concept" Study of TALL-104 (MHC Non-Restricted Cytotoxic T-Cell Line) and Imatinib Mesylate (Gleevec) in Chronic Myelogenous Leukemia in Chronic Phase

Rate is defined as number of participants with response of Major and Complete cytogenetic response out of total study participants. Response evaluated at one and 3 months from start of therapy, then every 3 months in patients with response, for one year, then every 6-12 months. Responses classified according to suppression of Philadelphia (Ph) chromosome by cytogenetic analysis: a) Complete cytogenetic response - Not Ph positive; b) Major cytogenetic response - Ph positive 1-34% of pretreatment value; c) Minor cytogenetic response - Ph positive 35-65% of pretreatment value; d) Minimal cytogenetic response - Ph positive 65-99% of pretreatment value; e) No cytogenetic response - Ph positive 100% of pretreatment value.

Abiogen Pharma

M.D. Anderson Cancer Center

TALL-104 cells and imatinib mesylate (IM) therapy

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

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

TALL-104 + IM

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Two participants withdrew from the study, and one died of a second, unrelated malignancy.

Jorge Cortes, MD / Professor, Leukemia

Baseline

1 Month

3 Months

12 Months

All three patients received the planned 9 administrations of TALL-104.

Response Rate (Major and Complete Cytogenetic Response)

TALL-104 cells and imatinib mesylate (IM) therapy. Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.

T Acute Lymphoblastic Leukemia/Lymphoma (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

Overall Study

Spots Global Cancer Trial Database for imatinib mesylate (im)