Clinical Trials List
2021-06-01 - 2026-02-01
Phase I/II
Recruiting6
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
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Sponsor
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Trial scale
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ting-An Lin 無
- Yao-Chung Liu 無
- Jyh-Pyng Gau 無
- Hao-Yuan Wang 無
- Po-Shen Ko 無
- Liang-Tsai Hsiao 無
- 李函叡 無
- Chia-Jen Liu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
injection
Injection
Active Ingredient
Mosunetuzumab
Mosunetuzumab
Tocilizumab
Polatuzumab Vedotin
Dosage Form
injection
Injection
Dosage
30 ml/vial
1 ml/vial
10 ml/vial
Vial
Endpoints
Trial Group A:
• To preliminarily evaluate the antitumor activity of mosunetuzumab IV in patients with a best response (PR) after first-line therapy for DLBCL.
Trial Group B:
• To preliminarily evaluate the antitumor activity of mosunetuzumab IV in older/unsuitable patients with previously untreated DLBCL.
Trial Group C: To evaluate the antitumor activity of mosunetuzumab SC versus polatuzumab vedotin IV in older/unsuitable patients with previously untreated DLBCL.
Inclution Criteria
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
Inclusion Criteria Specific to Cohort A
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
Inclusion Criteria Specific to Cohorts B and C
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
Exclusion Criteria
Participants who meet any of the following criteria will be excluded from study entry:
Transformed lymphoma
CNS lymphoma
Prior treatment with mosunetuzumab
Prior stem cell transplant (autologous and allogeneic)
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)
Positive SARS-CoV-2 antigen or PCR test within 30 days prior to Cycle 1 Day 1
Prior solid organ transplantation
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
Prior treatment with radiotherapy within 2 weeks prior to Cycle 1, Day 1 (C1D1)
Significant cardiovascular disease
The Estimated Number of Participants
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Taiwan
16 participants
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Global
189 participants
台灣臨床試驗主持人資料庫 TPIDB