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A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05091424
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE October 12, 2021
First Posted Date  ICMJE October 25, 2021
Last Update Posted Date May 6, 2023
Actual Study Start Date  ICMJE March 7, 2022
Estimated Primary Completion Date February 24, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2021)		 Rate of Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2022)
  • Objective Response Rate (ORR) [ Time Frame: Up to 8-12 weeks after the last dose of study drug ]
  • Minimal Residual Disease (MRD) Response Rate [ Time Frame: Up to 8-12 weeks after the last dose of study drug ]
  • Progression-Free Survival (PFS) [ Time Frame: From the first study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 12 months) ]
  • Overall Survival (OS) [ Time Frame: From the first dose of study drug to death from any cause (up to approximately 12 months) ]
  • Event-Free Survival (EFS) [ Time Frame: Between the date of the first study treatment to the date of disease progression/relapse, death, or start of new anti-leukemic therapy, whichever occurs first (up to approximately 12 months) ]
  • Complete Response (CR) Rate [ Time Frame: Up to 8-12 weeks after the last dose of study drug ]
  • Duration of Response (DOR) [ Time Frame: From the first occurrence of a documented objective response to disease progression by iwCLL 2018 criteria or death from any cause (up to approximately 12 months) ]
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 12 months ]
  • Maximum Serum Concentration (Cmax) of Mosunetuzumab SC [ Time Frame: Up to approximately 12 months ]
  • Minimum Serum Concentration (Cmin) of Mosunetuzumab SC [ Time Frame: Up to approximately 12 months ]
  • Time to Maximum Concentration (Tmax) of Mosunetuzumab SC [ Time Frame: Up to approximately 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2021)
  • Objective Response Rate (ORR) [ Time Frame: Up to 8-12 weeks after the last dose of study drug ]
  • Minimal Residual Disease (MRD) Response Rate [ Time Frame: Up to 8-12 weeks after the last dose of study drug ]
  • Progression-Free Survival (PFS) [ Time Frame: From the first study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 12 months) ]
  • Overall Survival (OS) [ Time Frame: From the first dose of study drug to death from any cause (up to approximately 12 months) ]
  • Event-Free Survival (EFS) [ Time Frame: Between the date of the first study treatment to the date of disease progression/relapse, death, or start of new anti-leukemic therapy (up to approximately 12 months) ]
  • Complete Response (CR) Rate [ Time Frame: Up to 8-12 weeks after the last dose of study drug ]
  • Duration of Response (DOR) [ Time Frame: From the first occurrence of a documented objective response to disease progression by iwCLL 2018 criteria or death from any cause (up to approximately 12 months) ]
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 12 months ]
  • Maximum Serum Concentration (Cmax) of Mosunetuzumab SC [ Time Frame: Up to approximately 12 months ]
  • Minimum Serum Concentration (Cmin) of Mosunetuzumab SC [ Time Frame: Up to approximately 12 months ]
  • Time to Maximum Concentration (Tmax) of Mosunetuzumab SC [ Time Frame: Up to approximately 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Official Title  ICMJE A Phase IB Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Brief Summary This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: Mosunetuzumab
    Participants will receive subcutaneous (SC) mosunetuzumab for up to 17 cycles (cycle = 21 days).
  • Drug: Tocilizumab
    Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.
Study Arms  ICMJE Experimental: R/R CLL
Participants will receive weekly step-up dosing of mosunetuzumab until the target dose is reached, after which mosunetuzumab will be administered once every 21 days for up to 17 cycles (cycle = 21 days) or until objective disease progression or unacceptable toxicity, whichever occurs first.
Interventions:
  • Drug: Mosunetuzumab
  • Drug: Tocilizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2021)		 56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2027
Estimated Primary Completion Date February 24, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable)
  • Participants who have received any of the following treatments prior to study entry: treatment with mosunetuzumab or other CD20/CD3-directed bispecific antibodies; allogenic stem cell transplant
  • Participants who have received any of the following treatments, whether investigational or approved, within the respective time periods prior to initiation of study treatment: radiotherapy within 2 weeks prior to the first dose of study treatment; autologous stem cell transplant within 100 days prior to first study treatment; CAR T-cell therapy within 30 days before first study treatment; use of monoclonal antibodies or antibody-drug conjugates within 4 weeks prior to first study treatment; systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of study treatment; any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment; other prior cancer immunotherapy not explicitly defined by the protocol is to be discussed with the medical monitor to determine eligibility
  • Received a live, attenuated vaccine within 4 weeks before the first dose of study treatment, or in whom it is anticipated that such a vaccine will be required during the study period or within 5 months after the final dose of study treatment
  • Transformation of CLL to aggressive non-Hodgkin's lymphoma (NHL)
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • Contraindication to tocilizumab
  • History of prior malignancy except for conditions defined by the protocol
  • Participants with infections requiring intravenous (IV) treatment with antibiotics or hospitalization within the last 4 weeks prior to enrollment or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment
  • Evidence of any significant concomitant disease that could affect compliance with the protocol or interpretation of results
  • Recent major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: BO43243 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Australia,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05091424
Other Study ID Numbers  ICMJE BO43243
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP