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Tests treatment safety and results for Chronic Lymphocytic Leukemia or Small Lymphocytic...
Official title A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT05091424
What this study is testing
What is Mosunetuzumab?
Mosunetuzumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma.
Also referred to as Lunsumio.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Adequate liver function unless directly attributable to the participant's CLL
- Life expectancy \> 6 months
You likely can't join if
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab and tocilizumab...
- Participants who have received any of the following treatments prior to study entry: treatment with mosunetuzumab or other CD20/CD3-directed...
- Participants who have received any of the following treatments, whether investigational or approved, within the respective time periods prior to...
- 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...
- 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...
See the full eligibility 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...
- 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 Specific to Arm B:
- 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...
- Non-US participants only
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab and tocilizumab or within 30 days after the final dose of venetoclax (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...
- 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...
- 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...
- 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)
- Positive SARS-CoV-2 test within 7 days prior to enrollment Exclusion Criteria Specific to Arm C:
- Have received venetoclax therapy within 12 months prior to first study treatment administration
- Participants with known infection with HIV or human T-cell leukemia virus 1 (HTLV1)
- HIV testing will be performed in countries where mandatory testing by health authorities is required
- HTLV testing is required in participants from endemic countries
- Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
- Participants who have received the following: strong and moderate CYP3A inhibitors within 7 days prior to the initiation of study treatment; strong and moderate CYP3A inducers within 7 days prior to the initiation of...
- Have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug and throughout venetoclax administration
- Inability to swallow a large number of tablets
- Malabsorption syndrome or other condition that precludes enteral route of administration
- Known allergy to both xanthine oxidase inhibitors and rasburicase
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Woolloongabba, Queensland, Australia
- East Melbourne, Victoria, Australia
- Melbourne, Victoria, Australia
- Beijing, China
- Guangzhou, China
- Nanchang, China
- Tianjin, China
- Clermont-Ferrand, France
- Toulouse, France
- Augsburg, Germany
- Cologne, Germany
- Ulm, Germany
- Brescia, Lombardy, Italy
- Milan, Lombardy, Italy
- Sant'Andrea Delle Fratte (PG), Umbria, Italy
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; New York, New York, United States; Columbus, Ohio, United States; Houston, Texas, United States; Salt Lake City, Utah, United States; Woolloongabba, Queensland, Australia and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.