A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
Status: | Recruiting |
---|---|
Conditions: | Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/10/2019 |
Start Date: | September 25, 2018 |
End Date: | June 18, 2022 |
Contact: | Reference Study ID Number: GO40516 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global.rochegenentechtrials@roche.com |
Phone: | 888-662-6728 (U.S. and Canada) |
An Open-Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma
This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of
mosunetuzumab in combination with polatuzumab vedotin in participants with B-cell non-Hodgkin
lymphoma (NHL). It will consist of a dose finding portion and two randomized cohorts for
participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular
lymphoma (FL).
mosunetuzumab in combination with polatuzumab vedotin in participants with B-cell non-Hodgkin
lymphoma (NHL). It will consist of a dose finding portion and two randomized cohorts for
participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular
lymphoma (FL).
Key Inclusion Criteria:
- ECOG PS of 0, 1, or 2
- Histologically confirmed FL or DLBCL
- Must have received at least one prior systemic treatment regimen containing an
anti-CD20−directed therapy for DLBCL or FL
- Relapsed to prior regimen(s) after having a documented history of response (complete
response [CR], CR unconfirmed [CRu], or partial response [PR]) of >/= 6 months in
duration from completion of regimen(s); or, refractory to any prior regimen, defined
as no response to the prior therapy, or progression within 6 months of completion of
the last dose of therapy
- Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion,
defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally
measurable extranodal lesion, defined as > 1.0 cm in its longest dimension
- Adequate hematologic, renal, and hepatic function
Key Exclusion Criteria:
- Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies
- Prior treatment with polatuzumab vedotin
- Current > Grade 1 peripheral neuropathy
- Prior use of any monoclonal antibody, radioimmunoconjugate or antibody-drug conjugate
(ADC) within 4 weeks before first dose of study treatment
- Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer
agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug,
whichever is shorter, prior to first dose of study treatment
- Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
- Autologous stem-cell transplantation (SCT) within 100 days prior to first study
treatment administration
- Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days
before first study treatment administration
- Prior allogeneic SCT
- Prior solid organ transplantation
- Patients with history of confirmed progressive multifocal leukoencephalopathy (PML)
- Current or past history of central nervous system (CNS) lymphoma or CNS disease
- History of autoimmune disease
We found this trial at
3
sites
1601 Northwest 12th Avenue
Miami, Florida 33136
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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New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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