A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT03677141
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • B-cell Non-Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Mosunetuzumab — DRUG
    Participants will receive intravenous (IV) mosunetuzumab.
  • Polatuzumab Vedotin — DRUG
    Participants will receive polatuzumab vedotin via IV.
  • Rituxumab — DRUG
    Participants will receive rituxumab via IV.
  • Cyclophosphamide — DRUG
    Participants will receive cyclophosphamide via IV.
  • Doxorubicin — DRUG
    Participants will receive doxorubicin via IV.
  • Vincristine — DRUG
    Participants will receive vincristine via IV.
  • Prednisone — DRUG
    Participants will receive oral prednisone.
  • Tocilizumab — DRUG
    Participants will receive tocilizumab via IV.

Study Details

This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).

Key Dates

Start date
Mar 8, 2019
Status verified
Nov 2024
Primary completion
Oct 12, 2023
Completion
Oct 12, 2023

Study Design

Enrollment
117 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding
    Participants will receive M-CHOP up to the phase II recommended dose (RP2D).
  • Experimental: Phase Ib: M-CHP-Pola Dose-Finding
    Participants will receive M-CHP-Pola up to the RP2D.
  • Experimental: Phase II: M-CHOP Previously Untreated (1L) DLBCL Safety Cohort
    Participants with 1L DLBCL will receive mosunetuzumab at the RP2D in combination with CHOP.
  • Experimental: Phase II: M-CHP-Pola 1L DLBCL
    Participants with 1L DLBCL will receive M-CHP-Pola at a dose determined in the dose finding stage.
  • Active Comparator: Phase II: Rituxumab (R)-CHP-Pola 1L DLBCL
    Participants with 1L DLBCL will receive R-CHP-Pola at a dose determined in the dose finding stage.
  • Experimental: Phase II: M-CHOP 1L DLBCL
    Participants with 1L DLBCL will receive M-CHOP at a dose determined in the dose finding stage. NOTE: No participants were enrolled to this arm.

Primary Outcome Measure

Complete Response (CR) Rate at the Time of Primary Response Assessment (PRA) Based on Positron Emission Tomography - Computed Tomography (PET-CT) as Determined by Independent Review Committee (IRC) [ Time Frame: 6-8 weeks after either C6D1 or last dose of study treatment ]

Locations (15)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35233-
Banner MD Anderson Cancer CenterGilbertArizona85234-
University of California; Moores Cancer CenterLa JollaCalifornia92093-
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa MonicaSanta MonicaCalifornia90404-2023-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
University of Miami Miller School of MedicineMiamiFlorida33136-
University of Kansas Cancer CenterWestwoodKansas66205-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of MichiganAnn ArborMichigan48109-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
Rhode Island HospitalProvidenceRhode Island02903-4923-
Vanderbilt University Medical CenterNashvilleTennessee37232-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-4009-
Scott and White Hospital; Cancer CenterTempleTexas76508-
Medical College of Wisconsin, Inc.MilwaukeeWisconsin53226-3596-

Find similar trials in Birmingham, AL

By research site
University of Alabama Birmingham· Birmingham, ALBanner MD Anderson Cancer Center· Gilbert, AZUniversity of California; Moores Cancer Center· La Jolla, CAUniversity of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica· Santa Monica, CAGeorgetown University Medical Center· Washington D.C., DCUniversity of Miami Miller School of Medicine· Miami, FL

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