Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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 stable disease or partial response, or in elderly/unfit participants with previously untreated DLBCL, or subcutaneous mosunetuzumab in combination with polatuzumab vedotin IV in elderly/unfit participants with previously untreated DLBCL.

Official Title

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

Keywords

Diffuse Large B-cell Lymphoma Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Mosunetuzumab Intravenous (IV) Mosunetuzumab Subcutaneous (SC) Polatuzumab Vedotin Tocilizumab

Eligibility

You can join if…

Open to people ages 18 years and up

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
  • 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 60-79 years and considered ineligible for chemoimmuotherapy (R-CHOP) with at least one of the following: Impairment in at least one activity of daily living as defined in the protocol; impairment in at least one instrumental activity of daily living as defined in the protocol; 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)

You CAN'T join if...

for All Cohorts

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)
  • History of hemophagocytic lymphohistiocytosis (HLH)
  • 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 Cohorts B and C

Participants in Cohorts B and C who meet the following criterion will be excluded from study entry:

  • Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy

Exclusion Criteria Specific to Cohort C

Participants in Cohort C who meet the following criteria will be excluded from study entry:

  • Current Grade >1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease

Locations

  • University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica accepting new patients
    Santa Monica California 90404-2023 United States
  • Providence Portland Medical Center not yet accepting patients
    Portland Oregon 97213 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03677154
Phase
Phase 1/2
Study Type
Interventional
Last Updated