Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab in participants with relapsed or refractory (R/R) leukemia-cll/" >chronic lymphocytic leukemia (CLL).

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Eligibility Criteria

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)

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

56

Study ID:

NCT05091424

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 15 Locations for this study

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Memorial Sloan-Kettering Cancer Center; Hematology/Oncology
New York New York, 10065, United States
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Woolloongabba Queensland, 4102, Australia
Monash Medical Centre; Haematology
Melbourne Victoria, 3168, Australia
Peter MacCallum Cancer Center
North Melbourne Victoria, 3051, Australia
CHU DE CLERMONT FERRAND; Service de Thérapie Cellulaire et d'Hématologie clinique adultes
Clermont-Ferrand , 63003, France
IUCT Oncopole; Hematologie
Toulouse , 31059, France
Uniklinik Koln; Klinik I fur Innere Medizin
Köln , 50937, Germany
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
Ulm , 89081, Germany
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia Lombardia, 25123, Italy
Osp. San Raffaele; Dip. Di Oncoematologia
Milano Lombardia, 20132, Italy
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia
Milano Lombardia, 20162, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Sant'Andrea Delle Fratte (PG) Umbria, 06132, Italy
Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia
Barcelona , 08025, Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona , 08035, Spain
Churchill Hospital; Department of Oncology
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

56

Study ID:

NCT05091424

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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