TALL-104 and Gleevec in Chronic Myelogenous Leukemia Patients

NCT00415909 | Terminated Phase 2 Results

• 1 other identifier: 2004-0837
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myelogenous Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Evaluated at baseline (pretreatment) up to 12 months

Study Arms (1)

TALL-104 + IM

EXPERIMENTAL

TALL-104 cells and imatinib mesylate (IM) therapy

Drug: Imatinib Mesylate (IM); Drug: TALL-104 cells

Interventions

Imatinib Mesylate (IM) DRUG

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

Also known as: Gleevec

TALL-104 + IM

TALL-104 cells DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Abiogen Pharma: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Jorge Cortes, MD / Professor, Leukemia
• Organization: University of Texas MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-794-5783

Study Officials

• Jorge E. Cortes, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2006
• First Posted: December 25, 2006
• Study Start: December 1, 2006
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 30, 2014
• Results First Posted: June 30, 2014

Record last verified: 2014-05

Locations

US (1)