A Study to Evaluate 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

Phase 1

• Conditions: B-Cell Non-Hodgkin Lymphoma (B-cell NHL); MedDRA version: 20.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-001039-29-ES
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-18
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

Phase Ib and Phase II
- Age >= 18 years
- At least one bi-dimensionally measurable nodal lesion
- Life expectancy of at least 24 weeks
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- Left ventricular ejection fraction defined by multiple-gated acquisition scan or echocardiogram within the institutional limits of normal
- Adequate hematologic function
- Contraception use
Phase Ib
- Histologically confirmed B-cell NHL according to WHO 2016 classification
- 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
Phase II
- Previously untreated, histologically confirmed DLBCL according to WHO 2016 classification
- International Prognostic Index score of 2-5
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

- Pregnant or breastfeeding, or intending to become pregnant during the study
- Prior treatment with mosunetuzumab and prior stem-cell transplant
- Contraindication to receive full dose of any of the individual components
- Current Grade >1 peripheral neuropathy
- Received systemic immunosuppressive medications
- Current or past history of central nervous system (CNS) lymphoma
- Current or past history of CNS disease
- Prior radiotherapy to the mediastinal/pericardial region
- History of other malignancy
- Recent major surgery
Phase Ib
- Prior treatment with >250 mg/m2 doxorubicin (or equivalent anthracycline dose)
- Prior treatment with chemotherapy, immunotherapy, and biologic therapy within a specified period
- Prior treatment with radiotherapy within a specified period
- Adverse events from prior anti-cancer therapy resolved to <= Grade 1
Phase II
- Patients with transformed lymphoma
- Prior therapy for B-cell NHL

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified