A Phase IB Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Who is this study for? Patients with relapsed or refractory chronic lymphocytic leukemia
What treatments are being studied? Mosunetuzumab
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first two cycles of mosunetuzumab. An additional arm (open to non-US participants only) has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) inhibitor.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Have a diagnosis of CLL requiring treatment according to the International Workshop on CLL (iwCLL) criteria (Hallek et al 2018)
• Eastern Cooperative Oncology Group (ECOG) performance score (PS) of ≤ 2
• Adequate bone marrow (BM) function independent of growth factor or transfusion support, within 2 weeks of screening, at screening as defined by the protocol unless cytopenia is clearly due to marrow involvement of CLL
• Adequate liver function unless directly attributable to the participant's CLL
• Life expectancy \> 6 months
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year, and agreement to refrain from donating eggs during the treatment period and for at least 3 months after the last dose of mosunetuzumab and 3 months after the last dose of tocilizumab (if applicable)
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm as defined by the protocol
• Participants must have been taking a BTKi for at least 12 months, have demonstrated evidence of progressive disease while receiving the BTKi and require additional salvage therapy as assessed by their treating physician. Participants should be able to continue their previously prescribed BTKi at a stable dose throughout the study screening period and for the first two cycles of mosunetuzumab administration
• Non-US participants only
Locations
United States
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
New York
Memorial Sloan-Kettering Cancer Center
WITHDRAWN
New York
Ohio
The James Cancer Hospital and Solove Research Institute
RECRUITING
Columbus
Texas
Uni of Texas - Md Anderson Cancer Center
WITHDRAWN
Houston
Utah
Huntsman Cancer Institute at The University of Utah
RECRUITING
Salt Lake City
Other Locations
Australia
Peter MacCallum Cancer Center
COMPLETED
East Melbourne
Monash Medical Centre
RECRUITING
Melbourne
Princess Alexandra Hospital Woolloongabba
RECRUITING
Woolloongabba
China
Southern Medical University Nanfang Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Tianjin Institute of Hematology & Blood Diseases Hospital
RECRUITING
Tianjin
France
Chu de Clermont Ferrand
WITHDRAWN
Clermont-ferrand
IUCT Oncopole
WITHDRAWN
Toulouse
Germany
Universitätsklinikum Augsburg
RECRUITING
Augsburg
Uniklinik Koln
WITHDRAWN
Cologne
Universitätsklinikum Ulm
RECRUITING
Ulm
Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
RECRUITING
Brescia
Asst Grande Ospedale Metropolitano Niguarda
COMPLETED
Milan
Osp. San Raffaele
RECRUITING
Milan
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
RECRUITING
Sant'andrea Delle Fratte (pg)
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gda?sk
PRATIA MCM Kraków
RECRUITING
Krakow
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
RECRUITING
Wroc?aw
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Seoul St Mary's Hospital
RECRUITING
Seoul
Yeouido St. Mary's Hospital
RECRUITING
Seoul
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
United Kingdom
Christie Hospital NHS Trust
RECRUITING
Manchester
Churchill Hospital
RECRUITING
Oxford
Contact Information
Primary
Reference Study ID Number: BO43243 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728
Time Frame
Start Date:2022-03-07
Estimated Completion Date:2030-02-28
Participants
Target number of participants:137
Treatments
Experimental: Arm A
Participants with R/R CLL who have failed two prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab subcutaneous (SC) monotherapy
Experimental: Arm B
Participants with R/R CLL who have failed two prior lines of therapy, who are currently progressing on BTKi therapy, and who require salvage therapy as assessed by their treating physician will receive mosunetuzumab SC with BTKi overlap therapy for the first two cycles of mosunetuzumab SC
Experimental: Arm C (non-US participants only)
Participants with R/R CLL who have failed two prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab SC with venetoclax (this arm is open only to participants outside of the US)