Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Conditions

• Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• High Grade B-Cell Lymphoma
• Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo PET/CT
• Lenalidomide — DRUG
  Given PO
• Mosunetuzumab — BIOLOGICAL
  Given IV
• Polatuzumab Vedotin — DRUG
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT

Study Details

This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab and polatuzumab vedotin are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab, linked to a toxic agent called vedotin, attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Giving mosunetuzumab with polatuzumab vedotin and lenalidomide may work better in treating patients with relapsed/refractory DLBCL.

Key Dates

Start date

May 20, 2024

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (mosunetuzumab, polatuzumab vedotin, lenalidomide)
  Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, and 15 of cycle 1 and then day 1 of each subsequent cycle. Cycles repeat every 28 days for 8 cycles in patients who achieve a CR or up to 17 cycles for patients with a PR or SD in the absence of disease progression or unacceptable toxicity. Patients also receive polatuzumab vedotin IV over 30-90 minutes on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles of polatuzumab vedotin repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Cycles of lenalidomide repeat every 28 days for 8 cycles in patients who achieve CR, or up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT and blood sample collection throughout the study.

Primary Outcome Measure

Safety and tolerability of monsunetuzumab+polatuzumab vedotin+lenalidomide for determination of recommended phase 2 dose [ Time Frame: During cycle 1 (cycle=28 days) ]

Locations (8)

Find similar trials in Duarte, CA

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