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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT06249191
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 13, 2024
Status verified
Apr 2026
Primary completion
Dec 1, 2026
Completion
Apr 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Mosunetuzumab and EPOCH)
    Patients receive mosunetuzumab 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 PO 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 MUGA at screening and PET scan, CT scan or MRI and blood sample collection throughout the study.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) (phase Ib) [ Time Frame: From the first dose of mosunetuzumab to the end of cycle 2 (1 cycle = 21 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Stephen E. Spurgeon
[email protected]
503-494-0174
Stephen E. Spurgeon (PRINCIPAL_INVESTIGATOR)

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By research site
OHSU Knight Cancer Institute· Portland, OR

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