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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) or small lymphocytic lymphoma (SLL). 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 three 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Participants with R/R CLL/SLL after two prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab subcutaneous (SC) monotherapy |
|
| Arm B | Experimental | Participants with R/R CLL/SLL after two or more 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 up to the first three cycles of mosunetuzumab SC |
|
| Arm C (non-US participants only) | Experimental | Participants with R/R CLL/SLL after two or more prior lines of therapy and who have had prior exposure to BTKi and/or venetoclax will receive mosunetuzumab SC with venetoclax during dose escalation phase. Participants with R/R CLL/SLL after at least one prior line of therapy must have prior exposure to BTKi and/or venetoclax and >12 months since last venetoclax exposure will receive mosunetuzumab SC with venetoclax during the dose expansion phase. During the dose expansion phase, a control cohort receiving the standard-of-care regimen of rituximab plus venetoclax has been added (this arm is open only to participants outside of the US). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mosunetuzumab | Drug | Participants will receive subcutaneous (SC) mosunetuzumab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Dose-Limiting Toxicities (DLTs) | Up to approximately 12 months (Arms A and B) or 24 months (Arm C) | |
| Objective Response Rate (ORR) During Dose Expansion Phase | Up to 8-12 weeks after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) During Dose Escalation Phase | Up to 8-12 weeks after the last dose of study drug | |
| Progression-Free Survival (PFS) | 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 (Arms A and B) or 24 months (Arm C)) |
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Inclusion Criteria:
Inclusion Criteria Specific to Arm B:
Inclusion Criteria Specific to Arm C:
Exclusion Criteria:
Exclusion Criteria Specific to Arm C:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BO43243 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55902 | United States | |
| Memorial Sloan-Kettering Cancer Center |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Tocilizumab | Drug | Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events. |
|
| Venetoclax | Drug | Participants will receive daily oral venetoclax. |
|
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| Rituximab | Drug | Participants will receive IV rituximab as per protocol. |
|
| Overall Survival (OS) | From the first dose of study drug to death from any cause (up to approximately 12 months (Arms A and B) or 24 months (Arm C)) |
| Event-Free Survival (EFS) | 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 (Arms A and B) or 24 months (Arm C)) |
| Complete Response (CR) Rate | Up to 8-12 weeks after the last dose of study drug |
| Duration of Response (DOR) | 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 (Arms A and B) or 24 months (Arm C)) |
| Duration of Complete Response (DOCR) | From the first occurrence of a documented complete response to disease progression by iwCLL 2018 criteria or death from any cause (up to approximately 12 months (Arms A and B) or 24 months (Arm C)) |
| Percentage of Participants with Adverse Events (AEs) | Up to approximately 12 months (Arms A and B) or 24 months (Arm C) |
| Maximum Serum Concentration (Cmax) of Mosunetuzumab SC | Up to approximately 12 months (Arms A and B) or 24 months (Arm C) |
| Minimum Serum Concentration (Cmin) of Mosunetuzumab SC | Up to approximately 12 months (Arms A and B) or 24 months (Arm C) |
| Time to Maximum Concentration (Tmax) of Mosunetuzumab SC | Up to approximately 12 months (Arms A and B) or 24 months (Arm C) |
| Maximum Serum Concentration (Cmax) of BTKi or Venetoclax | Up to approximately 12 months (Arms A and B) or 24 months (Arm C) |
| Minimum Serum Concentration (Cmin) of BTKi or Venetoclax | Up to approximately 12 months (Arms A and B) or 24 months (Arm C) |
| Time to Maximum Concentration (Tmax) of BTKi or Venetoclax | Up to approximately 12 months (Arms A and B) or 24 months (Arm C) |
| Incidence of Anti-Drug Antibodies (ADAs) | Baseline through end of study (up to approximately 12 months for Arms A and B, or 24 months for Arm C) |
| Withdrawn |
| New York |
| New York |
| 10065 |
| United States |
| The James Cancer Hospital and Solove Research Institute | Recruiting | Columbus | Ohio | 43210 | United States |
| Uni of Texas - Md Anderson Cancer Center | Withdrawn | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute at The University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
| Princess Alexandra Hospital Woolloongabba | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
| Peter MacCallum Cancer Center | Completed | East Melbourne | Victoria | 3002 | Australia |
| Monash Medical Centre | Recruiting | Melbourne | Victoria | 3168 | Australia |
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
| Southern Medical University Nanfang Hospital | Recruiting | Guangzhou | 510515 | China |
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
| Tianjin Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | 301600 | China |
| Chu de Clermont Ferrand | Withdrawn | Clermont-Ferrand | 63003 | France |
| IUCT Oncopole | Withdrawn | Toulouse | 31059 | France |
| Universitätsklinikum Augsburg | Recruiting | Augsburg | 86156 | Germany |
| Uniklinik Koln | Withdrawn | Cologne | 50937 | Germany |
| Universitätsklinikum Ulm | Active, not recruiting | Ulm | 89081 | Germany |
| A.O. Spedali Civili Di Brescia-P.O. Spedali Civili | Recruiting | Brescia | Lombardy | 25123 | Italy |
| Osp. San Raffaele | Recruiting | Milan | Lombardy | 20132 | Italy |
| Asst Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | Lombardy | 20162 | Italy |
| Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia | Recruiting | Sant'Andrea Delle Fratte (PG) | Umbria | 06132 | Italy |
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gda?sk | 80-214 | Poland |
| PRATIA MCM Kraków | Recruiting | Krakow | 30-727 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Recruiting | Wroc?aw | 50-367 | Poland |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Seoul St Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
| Yeouido St. Mary's Hospital | Recruiting | Seoul | 07345 | South Korea |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08025 | Spain |
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Christie Hospital NHS Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
| Churchill Hospital | Recruiting | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
| C579720 | venetoclax |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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