Leukemia, Myeloid, Chronic Clinical Trial
Official title:
Phase I Study of Zarnestra (R115777.USA30) and Gleevec (Imatinib Mesylate) in Chronic Phase Chronic Myelogenous Leukemia (CML)
The goal of this clinical research study is to find the highest safe dose of the drugs ZarnestraTM (R115777) and Gleevec (imatinib mesylate) that can be given in combination for the treatment of chronic myelogenous leukemia (CML) in chronic phase. The effect of this combination on the leukemia will also be studied.
R115777 is a new drug that blocks the function of an enzyme that is important in making some
proteins work. One of the most important targets for this enzyme is a protein that can make
cells become cancer. Imatinib mesylate is a drug that blocks the function of the protein
that comes from the Philadelphia chromosome. The Philadelphia chromosome is an abnormality
in chromosomes 9 and 22 that changes blood cells into leukemia cells.
Before treatment starts, participants will have a physical exam, blood tests (About 3 tubes,
2 teaspoons each), and a bone marrow biopsy. The bone marrow will be removed with a large
needle.
Participants in this study will take imatinib mesylate by mouth every day for as long as
they stay on study, which means as long as it works. Participants will also take R115777
twice a day for 2 weeks. This will be repeated every 3 weeks. The amount of each of these
medications that participants take will depend on when they enter the study. The doses will
be slowly increased from participant to participant until the highest dose that does not
cause serious side effects is found.
Participants will be asked to visit their doctor for a physical exam and measurement of
vital signs. The frequency of doctor visits will vary depending on physical condition. Blood
tests (about 2 teaspoons each) will be done every week during the first 3 weeks of
treatment. Blood tests will then be done every 8-12 weeks for the length of the study, as
needed. The blood samples will be used for routine lab tests. A bone marrow sample will also
be taken to check and measure cells related to the disease every 3 months in the first year
and then every 6-12 months. Participants can stay on study for as long as the treatment is
considered to be beneficial. Participants will be taken off study if their disease gets
worse or intolerable side effects occur.
This is an investigational study. The FDA has authorized the use of imatinib mesylate for
patients with CML. It is the combination of imatinib mesylate and R115777 that is
experimental. R115777 has been authorized for investigational use only. A maximum of 30
patients will take part in this study. All will be enrolled at M. D. Anderson.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00393380 -
Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor
|
Phase 2 | |
Completed |
NCT00186342 -
Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies
|
N/A | |
Completed |
NCT00759837 -
Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects
|
Phase 1 | |
Completed |
NCT00538109 -
An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
|
N/A | |
Terminated |
NCT00176930 -
Stem Cell Transplant for Hematological Malignancy
|
N/A | |
Recruiting |
NCT01015742 -
Unrelated Double Umbilical Cord Blood Units Transplantation
|
Phase 2/Phase 3 | |
Completed |
NCT00406393 -
Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)
|
Phase 3 | |
Completed |
NCT00246662 -
Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies
|
Phase 1 | |
Completed |
NCT00264160 -
Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
|
Phase 2/Phase 3 | |
Terminated |
NCT00306332 -
T-cell and B-cell Depletion in Allogeneic Peripheral Blood Stem Cell Transplantation
|
Phase 3 | |
Terminated |
NCT00058747 -
AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevecâ„¢
|
Phase 2 | |
Active, not recruiting |
NCT00538447 -
Prospective Database for Chronic Myelogenous Leukemia
|
N/A | |
Terminated |
NCT01050946 -
Hematopoietic Stem Cell Transplantation (HSCT) Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit
|
Phase 2 | |
Completed |
NCT00034684 -
Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04260022 -
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
|
Phase 1 | |
Terminated |
NCT00167180 -
Post Transplant Donor Lymphocyte Infusion
|
Phase 2 | |
Terminated |
NCT00449761 -
Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase
|
Phase 2 | |
Completed |
NCT00455221 -
Safety Assessment of a Multipeptide-gene Vaccine in CML
|
Phase 1 | |
Completed |
NCT00298987 -
A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate
|
Phase 2 | |
Completed |
NCT00763763 -
Imatinib Mesylate With Vincristine and Dexamethasone in Acute Lymphoblastic Leukemias With BCR-ABL Positive
|
Phase 2 |