Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT02446457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2015-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab and Pembrolizumab With or Without Lenalidomide in Treating Patients With Relapsed Follicular Lymphoma and Diffuse Large B-Cell Lymphoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Study of Rituximab Plus Pembrolizumab (MK-3475) in Subjects With Relapsed Follicular Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well rituximab and pembrolizumab with or without lenalidomide works in treating patients with follicular lymphoma and diffuse large B-cell lymphoma that has returned after a period of improvement. Immunotherapy with monoclonal antibodies, such as rituximab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rutuximab with pembrolizumab and lenalidomide may work better at treating follicular lymphoma and diffuse large B-cell lymphoma.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the overall response rate (ORR) in subjects with relapsed follicular lymphoma (FL) treated with rituximab plus pembrolizumab.
II. To determine the ORR in subjects with relapsed/refractory FL and relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who have failed chimeric antigen receptor (CAR) T cell therapy and are treated with rituximab in combination with pembrolizumab and lenalidomide. (Cohort 2)
SECONDARY OBJECTIVES:
I. To determine the safety and toxicity. II. To determine the complete response rate (CRR). III. To determine the overall progression-free survival (PFS). IV. To compare PFS between patients relapsing =\< one year vs \> one year after last prior therapy.
V. To determine the overall survival (OS). VI. To determine the safety and toxicity. (Cohort 2) VII. To determine the CRR. (Cohort 2) VIII. To determine the overall PFS. (Cohort 2) IX. To compare PFS between patients relapsing =\< one year vs \> one year after last prior therapy. (Cohort 2) X. To determine the OS. (Cohort 2)
EXPLORATORY OBJECTIVES:
I. To determine effects of rituximab plus pembrolizumab therapy on peripheral blood T cells.
II. To correlate features of peripheral blood T cells with toxicities after rituximab plus pembrolizumab therapy.
III. To correlate features of peripheral blood T cells with response and PFS after rituximab plus pembrolizumab therapy.
IV. To correlate baseline tumor characteristics with response and PFS after rituximab plus pembrolizumab therapy.
V. To determine effects of rituximab, pembrolizumab, and lenalidomide therapy on peripheral blood T cells. (Cohort 2) VI. To correlate features of peripheral blood T cells with toxicities after rituximab, pembrolizumab, and lenalidomide therapy. (Cohort 2) VII. To correlate features of peripheral blood T cells with response and PFS after rituximab, pembrolizumab, and lenalidomide therapy. (Cohort 2) VIII. To correlate baseline tumor characteristics with response and PFS after rituximab, pembrolizumab, and lenalidomide therapy. (Cohort 2)
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive rituximab intravenously (IV) over 4-8 hours on days 1, 8, 15, and 22. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 16 cycles (1 year) in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients receive rituximab IV over 4-8 hours on days 1, 8 and 15 of cycle 1, and day 1 of cycle 2. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 2 years, and lenalidomide orally (PO) on days 1-14 every 3 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year, and then every 6 months thereafter.
I. To determine the overall response rate (ORR) in subjects with relapsed follicular lymphoma (FL) treated with rituximab plus pembrolizumab.
II. To determine the ORR in subjects with relapsed/refractory FL and relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who have failed chimeric antigen receptor (CAR) T cell therapy and are treated with rituximab in combination with pembrolizumab and lenalidomide. (Cohort 2)
SECONDARY OBJECTIVES:
I. To determine the safety and toxicity. II. To determine the complete response rate (CRR). III. To determine the overall progression-free survival (PFS). IV. To compare PFS between patients relapsing =\< one year vs \> one year after last prior therapy.
V. To determine the overall survival (OS). VI. To determine the safety and toxicity. (Cohort 2) VII. To determine the CRR. (Cohort 2) VIII. To determine the overall PFS. (Cohort 2) IX. To compare PFS between patients relapsing =\< one year vs \> one year after last prior therapy. (Cohort 2) X. To determine the OS. (Cohort 2)
EXPLORATORY OBJECTIVES:
I. To determine effects of rituximab plus pembrolizumab therapy on peripheral blood T cells.
II. To correlate features of peripheral blood T cells with toxicities after rituximab plus pembrolizumab therapy.
III. To correlate features of peripheral blood T cells with response and PFS after rituximab plus pembrolizumab therapy.
IV. To correlate baseline tumor characteristics with response and PFS after rituximab plus pembrolizumab therapy.
V. To determine effects of rituximab, pembrolizumab, and lenalidomide therapy on peripheral blood T cells. (Cohort 2) VI. To correlate features of peripheral blood T cells with toxicities after rituximab, pembrolizumab, and lenalidomide therapy. (Cohort 2) VII. To correlate features of peripheral blood T cells with response and PFS after rituximab, pembrolizumab, and lenalidomide therapy. (Cohort 2) VIII. To correlate baseline tumor characteristics with response and PFS after rituximab, pembrolizumab, and lenalidomide therapy. (Cohort 2)
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive rituximab intravenously (IV) over 4-8 hours on days 1, 8, 15, and 22. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 16 cycles (1 year) in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients receive rituximab IV over 4-8 hours on days 1, 8 and 15 of cycle 1, and day 1 of cycle 2. Patients also receive pembrolizumab IV over 1 hour on day 2 every 3 weeks for up to 2 years, and lenalidomide orally (PO) on days 1-14 every 3 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year, and then every 6 months thereafter.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: