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



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:March 8, 2019
End Date:June 22, 2022
Contact:Reference Study ID Number: GO40515 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

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).


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 in 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
We found this trial at
9
sites
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Gilbert, Arizona 85234
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3855 Health Sciences Drive
La Jolla, California 92093
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335R Prairie Avenue
Providence, Rhode Island 02905
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Scottsdale, Arizona 85259
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Westwood, Kansas 66205
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