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Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/ Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma
EU CTIS ID: 2023-507498-16-00
What this study is testing
Cohort A To evaluate: ● A preliminary assessment of anti-tumor activity of mosunetuzumab (IV) in patients with best response of stable disease (SD) or partial response (PR) following first-line therapy for DLBCL ● Safety, tolerability, pharmacokinetics (PK) of mosunetuzumab intravenous (IV) in patients previously treated with first-line immunochemotherapy for DLBCL, including determination of the recommended dose for consolidation therapy Cohort B To evaluate: ● A preliminary assessment of anti-tumor activity of mosunetuzumab IV in elderly/unfit patients with previously untreated DLBCL ● Safety, tolerability, PK of mosunetuzumab IV in elderly/unfit patients with previously untreated DLBCL Cohort C: To evaluate: ● An assessment of overall anti-tumor activity of mosunetuzumab subcutaneous (SC) in combination with polatuzumab vedotin IV in elderly/unfit patients with previously untreated DLBCL ● Safety, tolerability, PK of mosunetuzumab SC in combination with polatuzumab vedotin IV in elderly/unfit patients with previously untreated DLBCL ● PK of polatuzumab vedotin IV when administered in combination with mosunetuzumab SC in elderly/unfit patients with previously untreated DLBCL
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For All Cohorts At least one bi-dimensionally measurable nodal (>1.5cm) lesion or extranodal (>1.0 Cm) lesion
- For All Cohorts Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2. Exception (Cohort C only): in South Korea, patients 80 years or older with ECOG >=2, will not be eligible
- Cohort A One prior therapy with any systemic anthracycline based chemoimmunotherapy containing regimen for previously untreated DLBCL and Best response of SD or PR to prior systemic chemoimmunotherapy at the end of the induction treatment in accordance with the Lugano 2014 criteria
- Cohort C Age >= 80 years or Patients who are 65−79 years of age, and considered ineligible for chemoimmunotherapy (R CHOP) at least one of the following: Impairment in >= 2 ADL component and/or Impairment in >= 2 instrumental ADL (IADL) component and/or CIRS-G score of at least 1 comorbidity with a severity score of 3-4 (not including lymphoma and hematologic deficiencies due to lymphoma) or a score of 2 in >=8 comorbidities
- Cohorts B and C Patients with an initial ECOG performance status of 3 may be considered during screening if the performance status is DLBCL-related and if pre-phase treatment during the screening phase results in an improvement of ECOG performance status to <=2 prior to enrollment
- Cohort B ≥ 80 years of age, or 60-79 years of age and unfit for full-dose chemotherapy because of poor performance status, impairments in ADL or instrumental activities of daily living (IADL), or other comorbidities
You likely can't join if
- For All Cohorts Transformed lymphoma, CNS lymphoma
- For All Cohorts Prior treatment with mosunetuzumab
- For All Cohorts History of confirmed progressive multifocal leukoencephalopathy (PML)
- Cohort A Prior anti-lymphoma treatment with chemotherapy, immunotherapy, or biologic therapy within 4 weeks prior to C1D1
- Cohorts B and C Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy Exception: patients in Cohort B who are treated with vincristine and prednisone as part of pre-phase treatment or patients in Cohort C who are treated with prednisone as part of pre-phase treatment
- Cohort C Current Grade >1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
- Taiwan
- Korea, Republic of
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States; Taiwan; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.