Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I/II Study of Vorinostat Plus Rituximab, Ifosphamide, Carboplatin, and Etoposide for Patients With Relapsed or Refractory Lymphoid Malignancies or Untreated T- or Mantle Cell Lymphoma
This phase I/II trial is studying the side effects and best dose of vorinostat when given together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well they work in treating patients with relapsed or refractory lymphoma or previously untreated T-cell non-Hodgkin lymphoma or mantle cell lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with rituximab and combination chemotherapy may kill more cancer cells
OBJECTIVES:
I. To determine maximally tolerated dose of vorinostat that can be combined with RICE
chemotherapy in patients with relapsed lymphoid malignancies.
II. To determine the safety and toxicity of the above regimen. III. To gain a preliminary
assessment of the efficacy of the above regimen. IV. To determine the ability to proceed to
peripheral blood stem cell collection following the above regimens (the impact of above
regimen on stem cell reserve).
V. To describe vorinostat concentration attained at or near the MTD. VI. To evaluate the
change of histone acetylation patterns and pro-apoptotic proteins of primary target (tumor)
and non-target peripheral blood mononuclear cells (PBMC) cells following high-dose HDAC
inhibition.
VII. To describe the gene expression profile changes of tumor and non-tumor cells following
high-dose HDAC inhibition.
OUTLINE: This is a phase I/II dose-escalation study of vorinostat.
Patients receive vorinostat orally (PO) once daily (QD) on days 1-5, ifosfamide IV
continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1
hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5.
Treatment repeats every 21 days for 2 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year and
then every 6 months for 4 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04635683 -
Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma
|
Phase 1 | |
Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
Active, not recruiting |
NCT02153580 -
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
|
Phase 1 | |
Active, not recruiting |
NCT01955499 -
Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
|
Phase 1 | |
Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
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 |
NCT00383565 -
FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 2 | |
Completed |
NCT00253630 -
Vorinostat in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
|
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 |
NCT00006473 -
Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 2 | |
Completed |
NCT00003196 -
Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma
|
N/A | |
Active, not recruiting |
NCT01318317 -
Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
Terminated |
NCT01678443 -
Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies
|
Phase 1 | |
Completed |
NCT01921387 -
Radiolabeled Monoclonal Antibody and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With High-Risk Lymphoid Malignancies
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01815749 -
Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma
|
Phase 1 | |
Recruiting |
NCT04007029 -
Modified Immune Cells (CD19/CD20 CAR-T Cells) in Treating Patients With Recurrent or Refractory B-Cell Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT01267812 -
Bortezomib and Rituximab in Treating Patients With Mantle Cell Lymphoma Who Have Previously Undergone Stem Cell Transplantation
|
Phase 2 | |
Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 |