Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I/Ib Study of the PD-1 Antibody Pembrolizumab in Combination With Ibrutinib in Relapsed/Refractory Non-Hodgkin's Lymphoma (NHL)
This phase I/Ib trial studies the side effects and best dose of ibrutinib when given together with pembrolizumab and to see how well they work in treating patients with non-Hodgkin lymphoma that has come back or does not respond to treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Given pembrolizumab and ibrutinib may work better in treating patients with non-Hodgkin lymphoma.
PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of the combination of ibrutinib and pembrolizumab
in patients with relapsed/refractory non-Hodgkin lymphoma (NHL).
II. To determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of the
combination of ibrutinib and pembrolizumab in patients with relapsed/refractory NHL.
III. To evaluate the efficacy of the combination of ibrutinib and pembrolizumab in patients
with relapsed/refractory NHL.
SECONDARY OBJECTIVES:
I. To determine the overall response rate (ORR), duration of response, progression-free
survival and overall survival of the combination of ibrutinib and pembrolizumab in patients
with relapsed/refractory NHL.
TERTIARY OBJECTIVES:
I. To explore the relationship between prognostic parameters including ki-67 staining, PD-1
staining and cell of origin (activated B-cell or ABC versus germinal center B-cell or GCB)
with ORR to the combination of ibrutinib and pembrolizumab in patients with
relapsed/refractory NHL.
II. To determine relationship between gene mutations and resistance to therapy with the
combination of ibrutinib and pembrolizumab in patients with relapsed/refractory NHL (BTK, PLC
gamma 2, PD-1).
III. To evaluate and monitor effects on B-, T-, and natural killer (NK)-cell function with
the combination of ibrutinib and pembrolizumab in patients with relapsed/refractory NHL.
OUTLINE: This is a phase I, dose-escalation study of ibrutinib followed by a phase Ib study.
Patients receive ibrutinib orally (PO) daily on days 1-21 and pembrolizumab intravenously
(IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 17 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days, and then every 3
months for 2 years and every 6 months for 3 years.
;
| 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 |