Non Hodgkin Lymphoma Clinical Trial
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
Summary
This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).
Eligibility Criteria
Inclusion Criteria for Phase Ib and Phase II Portions
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
Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
Adequate hematologic function
Inclusion Criteria for Phase Ib Portion
Participants must also meet the following criteria for study entry into the Phase Ib portion:
Histologically confirmed B-cell NHL according to the World Health Organization (WHO) 2016 classification expected to express the cluster of differentiation-20 (CD20) antigen
Relapsed or refractory (R/R) B-cell NHL after at least one prior systemic lymphoma therapy
Treatment with at least one prior CD20-directed therapy
Group B only: no prior treatment with polatuzumab vedotin
Inclusion Criteria for Phase II Portion
Participants must also meet the following criteria for study entry in the Phase II portion:
Previously untreated, histologically confirmed DLBCL according to WHO 2016 classification
International Prognostic Index (IPI) score of 2-5
Exclusion Criteria
Prior treatment with mosunetuzumab
Prior allogenic stem-cell transplant
Current Grade >1 peripheral neuropathy
Participants with 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
History of autoimmune disease
Current or past history of central nervous system (CNS) lymphoma
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
Significant cardiovascular disease or pulmonary disease
Clinically significant history of liver disease
Recent major surgery within 4 weeks before the start of C1D1, other than superficial lymph node biopsies for diagnosis
Exclusion Criteria for Phase Ib Portion
Participants who also meet any of the following criteria will be excluded from study entry in the Phase Ib portion:
Prior treatment with chemotherapy, immunotherapy, and biologic therapy 4 weeks prior to C1D1
Prior treatment with radiotherapy within 2 weeks prior to C1D1
Adverse events from prior anti-cancer therapy resolved to ≤Grade 1 (with the exception of alopecia and anorexia)
Prior treatment with >250 mg/m^2 doxorubicin (or equivalent anthracycline dose)
Exclusion Criteria for Phase II Portion
Participants who also meet any of the following criteria will be excluded from study entry in the Phase II portion:
Participants with transformed lymphoma
Prior therapy for B-cell NHL
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 40 Locations for this study
Birmingham Alabama, 35233, United States
La Jolla California, 92093, United States
Santa Monica California, 90404, United States
Greeley Colorado, 85234, United States
Washington District of Columbia, 20007, United States
Miami Florida, 33136, United States
Westwood Kansas, 66205, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Rochester Minnesota, 55905, United States
Providence Rhode Island, 02903, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Temple Texas, 76508, United States
Milwaukee Wisconsin, 53226, United States
Salzburg , 5020, Austria
Steyr , 4400, Austria
Wien , 1090, Austria
Wien , 1140, Austria
Creteil , 94010, France
Lyon , 69008, France
Paris , 75475, France
Saint Herblain , 44805, France
Villejuif , 94805, France
Gyeongsangnam-do , 50612, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Gliwice , 44-10, Poland
Kraków , 30-50, Poland
Slupsk , 76-20, Poland
Warsaw , 02-77, Poland
Wroc?aw , , Poland
Badalona Barcelona, 08916, Spain
Pamplona Navarra, 31008, Spain
Seville Sevilla, 41071, Spain
Barcelona , 08025, Spain
Caceres , 10003, Spain
Madrid , 28007, Spain
Madrid , 28014, Spain
Madrid , 28041, Spain
How clear is this clinincal trial information?