Stage IV Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase 2 Study of Tipifarnib in Large Granular Lymphocyte (LGL) Leukemia
This phase II trial is studying how well tipifarnib works in treating patients with anemia or neutropenia and large granular lymphocyte leukemia. Tipifarnib may stop the growth of leukemia by blocking blood flow to the cancer cells and by blocking some of the enzymes needed for cancer cell growth.
PRIMARY OBJECTIVES:
I. Estimate the complete response rate, partial response rate, and overall response rate in
patients with natural killer (NK)- or T-cell-large granular lymphocyte (LGL) leukemia who
present with neutropenia or anemia treated with tipifarnib.
SECONDARY OBJECTIVES:
I. Determine the toxicity of tipifarnib in these patients. II. Determine the mechanism of
treatment responses in these patients through correlative laboratory studies.
OUTLINE: Patients are stratified by disease type (natural killer-large granular lymphocyte
[LGL] leukemia vs T-cell-LGL leukemia).
Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days
for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are
evaluated after completion of course 4. Patients achieving complete response receive 1
additional course of treatment. Patients achieving partial response receive 4 additional
courses of treatment in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically during study for response mechanism studies
and other biomarker correlative studies, including mutations of K-ras and N-ras genes.
After completion of study treatment, patients are followed every 6 months for 5 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| 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 | |
| Terminated |
NCT00377104 -
Alvocidib in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
|
Phase 1 | |
| Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
| Completed |
NCT01441882 -
Dasatinib in Treating Patients With Chronic Lymphocytic Leukemia
|
Phase 2 | |
| Completed |
NCT00608361 -
Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery
|
Phase 1 | |
| Terminated |
NCT00288067 -
Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00095797 -
XK469R in Treating Patients With Refractory Hematologic Cancer
|
Phase 1 | |
| Completed |
NCT00098670 -
Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
|
Phase 2 | |
| Terminated |
NCT00947388 -
Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)
|
Phase 1 | |
| Terminated |
NCT00303966 -
Sorafenib in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
|
Phase 2 | |
| Completed |
NCT00112593 -
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer
|
N/A | |
| Completed |
NCT01129193 -
AR-42 in Treating Patients With Advanced or Relapsed Multiple Myeloma, Chronic Lymphocytic Leukemia, or Lymphoma
|
Phase 1 | |
| Withdrawn |
NCT01558778 -
Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant
|
N/A | |
| Completed |
NCT01024010 -
Ofatumumab, Pentostatin, and Cyclophosphamide in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
|
Phase 2 | |
| Completed |
NCT01029366 -
CART19 to Treat B-Cell Leukemia or Lymphoma That Are Resistant or Refractory to Chemotherapy
|
Phase 1 | |
| Completed |
NCT01789255 -
Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
| Active, not recruiting |
NCT01361711 -
Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia
|
Phase 2 | |
| Terminated |
NCT01076270 -
Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
N/A |