Refractory B-Cell Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Phase I Study of Ipilimumab in Combination With Rituximab in Patients With Relapsed/Refractory CD20+ B-Cell Lymphoma
This partially randomized phase I trial studies the side effects and best dose of ipilimumab when given together with rituximab in treating patients with B-cell lymphoma that has returned or has not responded to treatment. Monoclonal antibodies, such as ipilimumab and rituximab, may interfere with the ability of cancer cells to grow and spread.
PRIMARY OBJECTIVES:
I. To determine a recommended phase II dose for ipilimumab in combination with rituximab.
SECONDARY OBJECTIVES:
I. To obtain preliminary information on the effect of adding ipilimumab to rituximab in
regard to: immune response; clinical anti-tumor response/overall remission rate (ORR)
(complete remission + partial remission); progression free survival (PFS).
OUTLINE: This is a dose-escalation study of ipilimumab followed by a randomized study.
PART I:
INDUCTION: Patients receive ipilimumab intravenously (IV) over 90 minutes once every 3 weeks
for 12 weeks and rituximab IV over 2-6 hours once weekly for 4 weeks.
MAINTENANCE: Patients receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours
once every 12 weeks for up to 1 year.
PART II: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab
IV over 90 minutes once weekly in weeks 1, 4, 7, and 10. Patients then receive ipilimumab IV
over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the
absence of disease progression or unacceptable toxicity.
ARM B: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab
IV over 90 minutes once weekly in weeks 3, 6, 9, and 12. Patients then receive ipilimumab IV
over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
;
| 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| Withdrawn |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 | |
| Recruiting |
NCT05801913 -
Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) for the Treatment of Intermediate or High Grade B-Cell Non-Hodgkin Lymphoma
|
Phase 1 | |
| Withdrawn |
NCT03925428 -
Testing a New Anti-cancer Drug Combination, Entinostat and GSK525762C, for Advanced and Refractory Solid Tumors and Lymphomas
|
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 | |
| Recruiting |
NCT04892277 -
CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies
|
Phase 1 | |
| Withdrawn |
NCT03579927 -
CAR.CD19-CD28-zeta-2A-iCasp9-IL15-Transduced Cord Blood NK Cells, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Participants With B-cell Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT01701986 -
Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04578600 -
CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma
|
Phase 1 | |
| Recruiting |
NCT04447716 -
An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment
|
Phase 1 | |
| Recruiting |
NCT05272384 -
Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
|
Phase 1 | |
| Terminated |
NCT03103971 -
huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
|
Phase 1 | |
| Recruiting |
NCT05053971 -
Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors and Lymphomas
|
Phase 1/Phase 2 | |
| Terminated |
NCT01434472 -
High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma
|
Phase 2 | |
| Recruiting |
NCT04637763 -
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
|
Phase 1 | |
| Active, not recruiting |
NCT02628405 -
R-ICE and Lenalidomide in Treating Patients With First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04684472 -
Modified CD19 CAR-T in Patients With Relapsed or Refractory CD19+ B-cell Malignancies
|
Phase 1 | |
| Enrolling by invitation |
NCT05332054 -
Long-Term Follow-up Study
|
||
| Recruiting |
NCT06313957 -
A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
|
Phase 1 | |
| Recruiting |
NCT05583149 -
Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas
|
Phase 2 | |
| Recruiting |
NCT05627245 -
Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment
|
Phase 1 |