NCT06249191

Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma

A Phase Ib/II Study Evaluating the Safety and Efficacy of Mosunetuzumab in Combination With DA EPOCH in Previously Untreated C-Myc Rearrangement Positive High-Grade B Cell Lymphomas

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib/II clinical trial tests the safety, side effects, and effectiveness of mosunetuzumab with chemotherapy for the treatment of patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as mosunetuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone work in different ways to stop the growth of cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mosunetuzumab with chemotherapy may be safe, tolerable and/or effective in treating patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of the mosunetuzumab (M) plus dose-adjusted (DA) etoposide, doxorubicin, vincristine, cyclophosphamide, and prednisone \[EPOCH\] combination in previously untreated c-Myc + high-grade B cell lymphoma. (Phase Ib) II. Evaluate the efficacy of M DA EPOCH as complete response (CR) in previously untreated c-Myc + high grade B cell lymphoma. (Phase II) SECONDARY OBJECTIVES: I. Evaluate the efficacy of M DA EPOCH in Phase Ib and II as overall response, durability of response, and survival. II. Ongoing evaluation of the toxicity and tolerability of M DA EPOCH. (Phase Ib and II) III. Summarize DA EPOCH treatment details when received as part of M DA EPOCH. (Phase Ib and II) EXPLORATORY OBJECTIVES: I. Assess utilization and benefit of tocilizumab for toxicity management. (Phase Ib and II) II. Assess toxicity of M DA EPOCH based on immune related AEs (irAEs). (Phase Ib and II) III. Identify baseline factors of response and progression. (Phase Ib and II) IV. Assess the immune response to mosunetuzumab in the setting of the M DA EPOCH regimen. (Phase Ib and II) OUTLINE: Patients receive mosunetuzumab intravenously (IV), over 2-4 hours, on day 1, 8 and 15 of cycle 1 and day 1 of subsequent cycles. Patients receive etoposide IV, doxorubicin IV, and vincristine IV on days 1-4, cyclophosphamide IV, over 2 hours, on day 5 and prednisone orally (PO) twice per day (BID) on days 1-5 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity for up to 6 cycles. Patients undergo bone marrow aspiration and biopsy, tumor biopsy and may undergo echocardiography or multigated acquisition scan (MUGA) at screening and positron emission tomography (PET) scan, computed tomography (CT) scan or magnetic resonance imaging (MRI) and blood sample collection throughout the study. After completion of study treatment, patients are followed up every 3 months for 2 years then every 6 months for 3 years.

Conditions

• Diffuse Large B-Cell Lymphoma
• High Grade B-Cell Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo tumor biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Marrow Aspiration and Biopsy	Undergo bone marrow aspiration and biopsy
PROCEDURE	Computed Tomography	Undergo CT scan
DRUG	Cyclophosphamide	Given IV
DRUG	Doxorubicin	Given IV
PROCEDURE	Echocardiography	Undergo echocardiography
DRUG	Etoposide	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
BIOLOGICAL	Mosunetuzumab	Given IV
PROCEDURE	Multigated Acquisition Scan	Undergo MUGA
PROCEDURE	Positron Emission Tomography	Undergo PET scan
DRUG	Prednisone	Given PO
DRUG	Vincristine	Given IV

Timeline

• Start date: 2024-06-13
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2024-02-08
• Last updated: 2025-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study