Relapsing Chronic Myelogenous Leukemia Clinical Trial
Official title:
Phase II Study of Imatinib Mesylate (Gleevec, STI-571) (NSC#716051) and Decitabine (5-AZA-2'-Deoxycitidine) (NSC#127716), in Chronic Myelogenous Leukemia in Accelerated and Blastic Phases
This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may kill more cancer cells
OBJECTIVES:
I. Determine the duration of response and response rate in patients with accelerated or
blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.
II. Determine the survival rate of patients treated with this regimen. III. Determine the
toxicity of this regimen in these patients. IV. Determine the effects of this regimen on
gene methylation in the leukemic cells of these patients.
OUTLINE: Patients are stratified according to prior exposure to imatinib mesylate (yes vs
no).
Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days
per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20-80 patients (10-40 per stratum) will be accrued for this
study within 20 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
| Terminated |
NCT01426334 -
Dasatinib and Cyclosporine in Treating Patients With Chronic Myelogenous Leukemia Refractory or Intolerant to Imatinib Mesylate
|
Phase 1 | |
| Completed |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
| Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
| Terminated |
NCT00387426 -
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
|
Phase 2 | |
| Active, not recruiting |
NCT01056614 -
Fludarabine Phosphate, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Peripheral Blood Stem Cell Transplant, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Malignancies
|
Phase 2 | |
| Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT00052520 -
Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
|
Phase 1/Phase 2 | |
| Completed |
NCT00053963 -
FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia
|
Phase 1 | |
| Terminated |
NCT00052598 -
Therapeutic Allogeneic Lymphocytes and Aldesleukin in Treating Patients With High-Risk or Recurrent Myeloid Leukemia After Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
| Completed |
NCT00095797 -
XK469R in Treating Patients With Refractory Hematologic Cancer
|
Phase 1 | |
| Terminated |
NCT00101231 -
Flavopiridol in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia
|
Phase 1 | |
| Completed |
NCT00098423 -
Tanespimycin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, or Myelodysplastic Syndromes
|
Phase 1 | |
| Completed |
NCT00049192 -
Oblimersen and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
|
Phase 2 | |
| Completed |
NCT00040846 -
Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT00005799 -
Fludarabine Phosphate, Low-Dose Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer
|
N/A | |
| Completed |
NCT00006364 -
Homoharringtonine in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
|
Phase 2 | |
| Withdrawn |
NCT01558778 -
Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant
|
N/A | |
| Completed |
NCT01658319 -
Methoxyamine and Fludarabine Phosphate in Treating Patients With Relapsed or Refractory Hematologic Malignancies
|
Phase 1 |