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
18 Years
N/A
Both
Chronic Myelogenous Leukemia
Trial Information
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
Imatinib mesylate is designed to block the enzyme that is believed to be responsible for
starting the type of leukemia you have. 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.
Before you can start treatment on this study, you will have what are called "screening
tests." These tests will help the doctor decide if you are eligible to take part in the
study. Your complete medical history will be recorded. You will have a physical exam,
including measurement of your vital signs (blood pressure, heart rate, and temperature).
Blood (about 2 tablespoons) will be drawn for routine tests and 1 additional tablespoon will
be stored to be analyzed in case unexpected side effects occur after you receive your
therapy. You will have a bone marrow aspirate/biopsy to check the status of the leukemia.
To collect a bone marrow aspirate/biopsy, an area of the hip or chest bone is numbed with
anesthetic and a small amount of bone marrow/bone is withdrawn through a large needle.
Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy
test.
If you are found to be eligible to take part in this study, you will continue receiving
imatinib mesylate by mouth at the same schedule and dose you have been receiving before
entering the study. You will receive TALL-104 cells through a needle in your 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 your organs.
You 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 you receive your therapy. If you experience certain side effects, more blood
may need to be drawn and more tests performed based on the side effects you may experience.
You should inform the study staff if your address or telephone number changes.
This is an investigational study. TALL-104 is not FDA approved or commercially available.
It has been authorized for use in research only. Imatinib mesylate is FDA approved and
commercially available. Up to 20 patients will take part in this study. All will be
enrolled at M. D. Anderson.
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 BCR-ABL/ABL ratio of >/= 1-log confirmed in at least two consecutive 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 WBC
4. 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 x and AST or ALT of less than 2 x
upper limits of normal), and renal function (creatinine of less than 2 x 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 HIV.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response Rate (major and complete cytogenetic response)
Outcome Time Frame:
Evaluated at 12 months (rate of response by 3 months)
Safety Issue:
No
Principal Investigator
Jorge E. Cortes, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2004-0837
NCT ID:
NCT00415909
Start Date:
December 2006
Completion Date:
May 2013
Related Keywords:
- Chronic Myelogenous Leukemia
- Leukemia
- Chronic Myelogenous Leukemia
- CML
- Imatinib
- Gleevec
- TALL-104
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
