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TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients

Primary Purpose

Chronic Myelogenous Leukemia

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Imatinib Mesylate (IM)

TALL-104 cells

About this trial

This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring Leukemia, Chronic Myelogenous Leukemia, CML, Imatinib, Gleevec, TALL-104

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
*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.
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.
Eastern Cooperative Oncology Group (ECOG) scale performance status of 2 or less.
Age greater than 18 years of age since disease is extremely rare in younger age groups.
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).
Signed informed consent form.
Negative pregnancy test in women of childbearing age.
Negative hepatitis B and C screening blood tests.

Exclusion Criteria:

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.
Female patients who are pregnant or breast-feeding.
Patients taking steroids, or those anticipated to receive steroids during the trial therapy.
Prior bone marrow transplant.
Known positivity for human immunodeficiency virus (HIV).

Sites / Locations

UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TALL-104 + IM

Arm Description

TALL-104 cells and imatinib mesylate (IM) therapy

Outcomes

Primary Outcome Measures

Response Rate (Major and Complete Cytogenetic Response)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00415909

First Posted

December 22, 2006

Last Updated

May 29, 2014

Sponsor

M.D. Anderson Cancer Center

Collaborators

Abiogen Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00415909

Brief Title

TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Terminated

Why Stopped

Slow Accrual

Study Start Date

December 2006 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

Abiogen Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Myelogenous Leukemia

Keywords

Leukemia, Chronic Myelogenous Leukemia, CML, Imatinib, Gleevec, TALL-104

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TALL-104 + IM

Arm Type

Experimental

Arm Description

TALL-104 cells and imatinib mesylate (IM) therapy

Intervention Type

Drug

Intervention Name(s)

Imatinib Mesylate (IM)

Other Intervention Name(s)

Gleevec

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

TALL-104 cells

Intervention Description

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

Primary Outcome Measure Information:

Title

Response Rate (Major and Complete Cytogenetic Response)

Description

Time Frame

Evaluated at baseline (pretreatment) up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. *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. 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. Eastern Cooperative Oncology Group (ECOG) scale performance status of 2 or less. Age greater than 18 years of age since disease is extremely rare in younger age groups. 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). Signed informed consent form. Negative pregnancy test in women of childbearing age. Negative hepatitis B and C screening blood tests. Exclusion Criteria: 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. Female patients who are pregnant or breast-feeding. Patients taking steroids, or those anticipated to receive steroids during the trial therapy. Prior bone marrow transplant. Known positivity for human immunodeficiency virus (HIV).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge E. Cortes, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

UT MD Anderson Cancer Center website

Learn more about this trial

TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients

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