A study of pinatuzumab vedotin (DCDT2980S) combined with rituximab and polatuzumab vedotin (DCDS4501A) combined with rituximab or obinutuzumab in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma.

Phase 1

• Conditions: Follicular Non-Hodgkin’s Lymphoma (FL); Diffuse Large B-Cell Lymphoma (DLBCL); MedDRA version: 20.1 Level: LLT Classification code 10012857 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10012855 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) System Organ Class: 100000004864; MedDRA version: 20.1 Level: LLT Classification code 10012856 Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrent System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004377-84-DE
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-02
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

- Life expectancy of at least 12 weeks;
- Age > or = 18 years;
- History of histologically documented relapsed or refractory Grades 1-3a FL, or relapsed or refractory DLBCL;
- Must have at least one bi-dimensionally measurable lesion;
- Adequate hepatic, renal and cardiopulmonary function;
- For all men and women of childbearing potential use of adequate methods of contraception.
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 61
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 185

Exclusion Criteria

- Prior use of any monoclonal antibody, radioimmunoconjugate or antibody-drug conjugate within 4 weeks before Cycle 1 Day1;
- Treatment with radiotherapy, chemotherapy, immunotherapy, or an investigational anti-cancer agent within 2 weeks prior to Cycle 1 Day 1;
- Prior autologous stem cell transplant within 100 days prior to Cycle 1 Day 1;
- Prior allogeneic stem cell transplant;
- Eligibility for autologous stem cell transplant.

Study & Design

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