Mosunetuzumab in Combination With Platinum-Based Salvage Chemotherapy in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05464329
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Follicular Lymphoma Grade 3B
  • High-grade B-cell Lymphoma
  • Large B-cell Lymphoma
  • Transformed B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mosunetuzumab — DRUG
    Provided by Genentech.
  • DHAX — DRUG
    -Standard of care. Flexibility in administration is permitted at the discretion of the treating physician.
  • ICE — DRUG
    -Standard of care. Flexibility in administration is permitted at the discretion of the treating physician.

Study Details

This is a two-arm, open-label, phase Ib single-site study with expansion cohorts testing the addition of mosunetuzumab to intensive platinum-based salvage chemotherapy in patients with relapsed/refractory aggressive B cell lymphoma. The hypothesis of this study is that mosunetuzumab can be safely combined with platinum-based salvage chemotherapy in this patient population, and that this approach may outperform chemoimmunotherapy approaches that instead incorporate rituximab retreatment. The enrolling physician's choice of the chemotherapy backbone will determine a patient's assigned study arm (Arm A = DHAX, Arm B = ICE). The two arms will accrue patients to phase Ib independently.

Key Dates

Start date
Jan 3, 2023
Status verified
Jan 2026
Primary completion
Jan 2, 2026
Completion
Oct 16, 2029

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Mosunetuzumab + DHAX
    * 4 cycles (cycle=21 days) of mosunetuzumab with DHAX salvage chemotherapy (selected at the discretion of the treating physician). * For patients tolerating Cycle 1 with step-up of treatment, Cycles 2 and beyond will consist of mosunetuzumab administered as a single dose on Day 1 along with DHAX. Patients will undergo PET-CT restaging prior to Cycle 3. Patients with SD or PD based on restaging after Cycle 2 will discontinue study treatment; further treatment will be administered at the discretion of the treating physician. Patients responding to study treatment based on restaging after Cycle 2 may receive up to two additional cycles of study treatment before consolidation therapy (e.g., autologous stem cell transplantation, chimeric antigen receptor T-cell therapy) at the discretion of the treating physician.
  • Experimental: Arm B: Mosunetuzumab + ICE
    * 4 cycles (cycle=21 days) of mosunetuzumab with ICE salvage chemotherapy (selected at the discretion of the treating physician). * For patients tolerating Cycle 1 with step-up of treatment, Cycles 2 and beyond will consist of mosunetuzumab administered as a single dose on Day 1 along with ICE. Patients will undergo PET-CT restaging prior to Cycle 3. Patients with SD or PD based on restaging after Cycle 2 will discontinue study treatment; further treatment will be administered at the discretion of the treating physician. Patients responding to study treatment based on restaging after Cycle 2 may receive up to two additional cycles of study treatment before consolidation therapy (e.g., autologous stem cell transplantation, chimeric antigen receptor T-cell therapy) at the discretion of the treating physician.

Primary Outcome Measure

Frequencies and grades of treatment-emergent adverse events (TEAEs) [ Time Frame: From start of treatment through 30 days after administration of study treatment, or until initiation of alternate treatment for lymphoma, whichever occurs earlier (estimated to be 16 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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By research site
Washington University School of Medicine· St Louis, MO

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