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NCT03677154CompletedPhase 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 Immunotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Source: ClinicalTrials.gov · Last updated 21 Aug 2025

Brief summary (registry, in English)

This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy in participants with a best response of stable disease or partial response, or in elderly/unfit participants with previously untreated DLBCL, or subcutaneous mosunetuzumab in combination with polatuzumab vedotin IV in elderly/unfit participants with previously untreated DLBCL.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
188 (actual)
First submitted
11 Sept 2018
Start date
May 2019
Primary completion date
Aug 2025
Lead sponsor
Hoffmann-La Roche
NCT number
NCT03677154

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 188
  • From May 2019 to the primary completion date, Aug 2025
  • 32 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with mosunetuzumab
  • Prior stem cell transplant (autologous and allogeneic)
  • Positive SARS-CoV-2 antigen or PCR test within 30 days prior to Cycle 1 Day 1
  • Prior solid organ transplantation
  • Prior treatment with radiotherapy within 2 weeks prior to Cycle 1, Day 1 (C1D1)
  • \- Prior anti-lymphoma treatment with chemotherapy, immunotherapy, or biologic therapy 4 weeks prior to C1D1
  • \- Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy

Other illness

  • History of confirmed progressive multifocal leukoencephalopathy (PML)
  • Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV)
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Clinically significant history of liver disease
  • Significant cardiovascular disease
  • \- Current Grade \>1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease

Other

  • Participants who meet any of the following criteria will be excluded from study entry:
  • Transformed lymphoma
  • CNS lymphoma
  • Participants in Cohort A who meet the following criteria will be excluded from study entry:
  • Exclusion Criterion Specific to Cohorts B and C
  • Participants in Cohorts B and C who meet the following criterion will be excluded from study entry:
  • Participants in Cohort C who meet the following criteria will be excluded from study entry:

Who the study is looking for

  • At least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest diameter
  • Adequate hematologic function
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2; with the exception of South Korea, where participants 80 years or older with ECOG \>/= 2 will not be eligible
  • Participants in Cohort A must also meet the following criteria for study entry:
  • Histologically confirmed DLBCL according to World Health Organization (WHO) 2016 expected to express the cluster of differentiation-20 (CD20) antigen
  • One prior therapy with any systemic anthracycline-based chemoimmunotherapy containing regimen for previously untreated DLBCL
  • Best response of SD or PR to prior systemic chemoimmunotherapy at the end of induction treatment in accordance with the Lugano 2014 criteria
  • Participants in Cohorts B and C must also meet the following criteria for study entry:
  • Previously untreated, histologically confirmed, DLBCL according to WHO 2016 classification
  • Age \>/= 80 years, or
  • Age 65-79 years and considered ineligible for chemoimmuotherapy (R-CHOP) with at least one of the following: Impairment in at least two activity of daily living (ADL) components as defined in the protocol; impairment in at least two instrumental ADL components as defined in the protocol; cumulative illness rating scale - geriactic (CIRS-G) score of at least one cormorbidity with a severity score of 3-4 (not including lymphoma and hematologic deficiencies due to lymphoma) or a score of 2 in \>/= 8 comorbidities; impairment in cardiac function, renal function, liver function, or other comorbidities such that the participant is unfit for full-dose immunochemotherapy, such as rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)
  • Participants 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 (not more than 100 mg/day up to 7 days prior to Cycle 1 Day 1) results in an improvement of ECOG performance status to \</= 2 prior to enrollment

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario Vall d'Hebron
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BarcelonaSpainUnknown status
Institut Català d'Oncologia Hospitalet
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BarcelonaSpainUnknown status
Hospital San Pedro De Alcántara
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CáceresSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital General Universitario Gregorio Marañón
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MadridSpainUnknown status
Hospital Universitario Virgen Macarena
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SevilleSpainUnknown status
Soroka Medical Center
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BeershebaIsraelUnknown status
Carmel Medical Center
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HaifaIsraelUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Hadassah Ein-Karem
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JerusalemIsraelUnknown status
Meir Medical Center
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Kfar SabaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Keimyung University Dongsan Hospital
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DaeguSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital Yonsei University
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Yeouido St. Mary's Hospital
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SeoulSouth KoreaUnknown status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandUnknown status
Pratia MCM Krakow
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KrakowPolandUnknown status
Centrum Onkologii Ziemi Lubelskiej im. w. Jana z Dukli
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LublinPolandUnknown status
Szpital Wojewodzki w Opolu
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OpolePolandUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
University of Maryland Medical Center
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BaltimoreUnited StatesUnknown status
University of Alabama at Birmingham School of Medicine
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BirminghamUnited StatesUnknown status
Texas Oncology - Baylor Charles A. Sammons Cancer Center
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DallasUnited StatesUnknown status
Duke University
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DurhamUnited StatesUnknown status
Fort Wayne Medical Institute
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Fort WayneUnited StatesUnknown status
Fox Chase Cancer Center
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PhiladelphiaUnited StatesUnknown status
Rhode Island Hospital
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ProvidenceUnited StatesUnknown status
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
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Santa MonicaUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.