A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

• Status: Active, not recruiting
• Trial end date: 2022-02-23
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and lenalidomide in participants with relapsed or refractory (R/R) follicular lymphoma (FL) and rituximab in combination with polatuzumab vedotin and lenalidomide in participants with R/R diffuse large B-cell lymphoma (DLBCL), followed by post-induction treatment with obinutuzumab in combination with lenalidomide in participants with FL who achieve a complete response (CR), partial response (PR), or stable disease (SD) at end of induction (EOI) and post-induction treatment with rituximab plus lenalidomide in participants with DLBCL who achieve a CR or PR at EOI.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal; Immunoconjugates; Lenalidomide; Obinutuzumab; Rituximab; Thalidomide

Criteria

Inclusion Criteria:

• Age greater than or equal to (>/=) 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

• For obinutuzumab in combination with polatuzumab vedotin and lenalidomide (G + Pola + Len) treatment group: R/R FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator

• For rituximab in combination with polatuzumab vedotin and lenalidomide (R + Pola + Len) treatment group: R/R DLBCL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody in patients who are not eligible for autologous stem-cell transplantation or who have experienced disease progression following treatment with high-dose chemotherapy plus autologous stem-cell transplantation

• Histologically documented CD20-positive B-cell lymphoma as determined by the local laboratory

• fluorodeoxyglucose (FDG)-avid lymphoma (i.e., positron emission tomography (PET)-positive lymphoma)

• At least one bi-dimensionally measurable lesion

• Agreement to remain abstinent or use adequate contraception, among women or men of childbearing potential

Exclusion Criteria:

• Grade 3b follicular lymphoma

• History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)

• Known CD20-negative status at relapse or progression

• Central nervous system (CNS) lymphoma or leptomeningeal infiltration

• Prior allogeneic stem-cell transplantation (SCT), or autologous SCT within 100 days prior to Day 1 of Cycle 1

• Current use of systemic immunosuppressant(s), or prior anti-cancer therapy to include:

lenalidomide, fludarabine, or alemtuzumab within 12 months; radioimmunoconjugate within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1

• Active infection

• Positive for human immunodeficiency virus (HIV) or hepatitis B or C

• Receipt of a live virus vaccine within 28 days prior to Day 1 of Cycle 1

• Poor hematologic, renal, or hepatic function

• Pregnant or lactating women

• Life expectancy less than (<) 3 months