2023-507498-16-00CompletedPhase 1/2
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
A Phase I/II Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Patients with Diffuse Large B-Cell Lymphoma following First-Line Immunochemotherapy and as Monotherapy or In Combination With Polatuzumab Vedotin in Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Jul 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 27 Feb 2024
- Start date
- 2 Jul 2019
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Diffuse large B-cell lymphoma
- EU CT number
- 2023-507498-16-00
- EudraCT number
- 2018-001127-40
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 39
- 10 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- For All Cohorts Prior treatment with mosunetuzumab
- 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
Other illness
- For All Cohorts History of confirmed progressive multifocal leukoencephalopathy (PML)
- Cohort C Current Grade >1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
Other
- For All Cohorts Transformed lymphoma, CNS lymphoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Completed |
| Hospital San Pedro De Alcántara | Cáceres | Spain | Completed |
| Institut Catala D'oncologia | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Completed |
| Hospital Universitario Virgen De La Macarena | Sevilla | Spain | Completed |
| Pratia S.A. | Cracow | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Completed |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli | Lublin | Poland | Completed |
| Szpital Wojewodzki W Opolu Sp. z o.o. | Opole | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.