A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04246086
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Mosunetuzumab (IV) — DRUG
    Participants will receive IV mosunetuzumab as defined by the study protocol
  • Tocilizumab — DRUG
    Participants will receive IV tocilizumab as needed for adverse reactions as defined by the study protocol
  • Lenalidomide — DRUG
    Participants will receive oral lenalidomide as defined by the study protocol
  • Mosunetuzumab (SC) — DRUG
    Participants will receive SC mosunetuzumab as defined by the study protocol

Study Details

This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab (Mosun) + lenalidomide (Len) (Mosun + Len) in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.

Key Dates

Start date
Aug 12, 2020
Status verified
Mar 2026
Primary completion
Sep 6, 2030
Completion
Sep 6, 2030

Study Design

Enrollment
237 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Intravenous (IV) Mosunetuzumab + Lenalidomide (Non-randomized)
    Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
  • Experimental: Subcutaneous (SC) Mosunetuzumab + Lenalidomide (Non-randomized)
    Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward). Participants that have received complete metabolic response (CMR) or partial metabolic response (PMR) after 12 cycles of induction therapy with mosunetuzumab + lenalidomide will receive maintenance therapy with SC mosunetuzumab every 8 weeks (Q8W) for an additional 9 cycles.
  • Experimental: Arm A: IV Mosunetuzumab + Len (Randomized)
    Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
  • Experimental: Arm B: SC Mosunetuzumab + Len (Randomized)
    Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)

Primary Outcome Measure

Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 2 Days 1-28 (cycle length = 28 days) ]

Locations (13)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
University of Miami Miller School of MedicineMiamiFlorida33136-1002-
Norton Cancer Institute - St. MatthewsLouisvilleKentucky40207-4723-
Mary Bird Perkins Cancer CtrBaton RougeLouisiana70809-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Duke University Medical CenterDurhamNorth Carolina27710-4000-
Cleveland ClinicClevelandOhio44195-0001-
Fairview HospitalClevelandOhio44111-
Hillcrest HospitalMayfield HeightsOhio44124-
Rhode Island Hematology/Oncology ProgramWoonsocketRhode Island02895-4720-
Tennessee Oncology;Chattanooga Oncology & Hematology AssociatesChattanoogaTennessee37404-
Tennessee Oncology PLLC - FranklinFranklinTennessee37067-
Swedish Medical CenterSeattleWashington98122-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAUniversity of Miami Miller School of Medicine· Miami, FLNorton Cancer Institute - St. Matthews· Louisville, KYMary Bird Perkins Cancer Ctr· Baton Rouge, LAUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIDuke University Medical Center· Durham, NC

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