A Phase Ib/II, Open-Label, Multicenter Study With a Non-Randomized Stage Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab Plus Lenalidomide (+Len), and a Randomized Stage Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Patients With Follicular Lymphoma

Who is this study for? Patients with Follicular Lymphoma
Status: Recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

• R/R FL after treatment with at least one prior systemic lymphoma therapy, which includes prior immunotherapy or chemoimmunotherapy

• Previously untreated participants with FL must require systemic therapy assessed by investigator based on the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria and have a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5

• Histologically documented FL of Grade 1, 2, or 3a, and that expresses CD20 at time of diagnosis as determined by the local laboratory

• Fluorodeoxyglucose avid lymphoma (i.e., positron emission tomography (PET) positive lymphoma)

• At least one bi dimensionally measurable nodal lesion (\>1.5 cm in its largest dimension by PET- computed tomography (CT) scan), or at least one bi dimensionally measurable extranodal lesion (\>1.0 cm in its largest dimension by PET-CT scan)

• Availability of a representative tumor specimen and the corresponding pathology report for confirmation of the diagnosis of FL

• Adequate hematologic function (unless due to underlying lymphoma, per the investigator) as defined by the protocol

• Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/mL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months

• Normal laboratory values (unless due to underlying lymphoma) as defined by the protocol

• Agreement to comply with all local requirements of the Len risk minimization plan

• For women of childbearing potential: agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of \< 1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period, and for at least 12 months after the final dose of glofitamab, 28 days after the last dose of Len, 18 months after the last dose of G, 3 months after the final dose of tocilizumab, and 3 months after the final dose of Mosun. Women must refrain from donating eggs during this same period

• For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, with female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 2 months after the final dose of glofitamab, 28 days after last dose of Len, 18 months after the last dose of G, 3 months after the final dose of tocilizumab, and 3 months after the final dose of Mosun

Locations
United States
California
City of Hope National Medical Center
RECRUITING
Duarte
Florida
University of Miami Miller School of Medicine
RECRUITING
Miami
Louisiana
Mary Bird Perkins Cancer Ctr
RECRUITING
Baton Rouge
Michigan
University of Michigan Comprehensive Cancer Center
RECRUITING
Ann Arbor
North Carolina
Duke University Medical Center
RECRUITING
Durham
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Fairview Hospital
RECRUITING
Cleveland
Hillcrest Hospital
RECRUITING
Mayfield Heights
Rhode Island
Rhode Island Hematology/Oncology Program
RECRUITING
Woonsocket
Tennessee
Tennessee Oncology;Chattanooga Oncology & Hematology Associates
RECRUITING
Chattanooga
Tennessee Oncology PLLC - Franklin
RECRUITING
Franklin
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
China
the First Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer Hospital
WITHDRAWN
Changsha
West China Hospital, Sichuan University
RECRUITING
Chengdu
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjing
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
France
CHRU de Lille - Hopital Claude Huriez
WITHDRAWN
Lille
CHU Montpellier
WITHDRAWN
Montpellier
Hôpital Saint-Louis
WITHDRAWN
Paris
Centre Hospitalier Lyon Sud
ACTIVE_NOT_RECRUITING
Pierre-bénite
CHU Rennes - Hopital Pontchaillou
ACTIVE_NOT_RECRUITING
Rennes
Institut Claudius Regaud
WITHDRAWN
Toulouse
Spain
Hospital Universitario Vall d Hebron
WITHDRAWN
Barcelona
Hospital Universitario Fundacion Jimenez Diaz.
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
ACTIVE_NOT_RECRUITING
Málaga
Complejo Asistencial Universitario de Salamanca
WITHDRAWN
Salamanca
United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
ACTIVE_NOT_RECRUITING
London
The Christie NHS Foundation Trust
ACTIVE_NOT_RECRUITING
Manchester
Freeman Hospital
COMPLETED
Newcastle Upon Tyne
Nottingham University Hospitals NHS Trust - City Hospital
ACTIVE_NOT_RECRUITING
Nottingham
Oxford University Hospitals NHS Foundation Trust
WITHDRAWN
Oxford
Contact Information
Primary
Reference Study ID Number: CO41942 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728
Time Frame
Start Date: 2020-08-12
Estimated Completion Date: 2030-10-15
Participants
Target number of participants: 237
Treatments
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)
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov