A Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Therapy in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma Who Are Unable to Tolerate Full-Dose Chemotherapy
Status: | Recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/10/2019 |
Start Date: | March 15, 2019 |
End Date: | October 3, 2023 |
Contact: | Reference Study ID Number: GO40554 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global.rochegenentechtrials@roche.com |
Phone: | 888-662-6728 (U.S. and Canada) |
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 Therapy in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma Who Are Unable to Tolerate Full-Dose Chemotherapy
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 partial response, or in participants with previously
untreated DLBCL who are unable to tolerate full-dose, first-line immunochemotherapy.
mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy
in participants with a best response of partial response, or in participants with previously
untreated DLBCL who are unable to tolerate full-dose, first-line immunochemotherapy.
Inclusion Criteria for All Cohorts
- 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
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
- Best response of PR to prior systemic chemotherapy at the end of induction treatment
in accordance with Lugano 2014 Response Criteria
Inclusion Criteria Specific to Cohort B
Participants in Cohort B must also meet the following criteria for study entry:
- Previously untreated, histologically confirmed, DLBCL according to WHO 2016
classification
Exclusion Criteria for All Cohorts
Participants who meet any of the following criteria will be excluded from study entry:
- Transformed 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)
- 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
Exclusion Criteria Specific to Cohort A
Participants in Cohort A who meet the following criteria will be excluded from study entry:
- Prior treatment with chemotherapy, immunotherapy, or biologic therapy 4 weeks prior to
C1D1
Exclusion Criterion Specific to Cohort B
Participants in Cohort B who meet the following criterion will be excluded from study
entry:
- Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy
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