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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)
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)

NCT02600897

CompletedPhase 1, Phase 2

Sponsor: Hoffmann-La Roche

Conditions: Relapsed or Refractory Follicular Lymphoma, Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Interventions: Lenalidomide, Obinutuzumab, Polatuzumab Vedotin, Rituximab

Countries: United States, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (28)
  • Marietta, Georgia, United States
  • Detroit, Michigan, United States
  • Columbia, Missouri, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • Irving, Texas, United States
  • Irving, Texas, United States
  • San Antonio, Texas, United States
  • L'Hospitalet de Llobregat, Barcelona, Spain
  • Málaga, Malaga, Spain
  • Pamplona, Navarre, Spain
  • Pamplona, Navarre, Spain
  • Barcelona, Spain
  • Barcelona, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Valencia, Spain
  • Leeds, United Kingdom
  • Leicester, United Kingdom
  • Liverpool, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • Maidstone, United Kingdom
  • Nottingham, United Kingdom
  • Romford, United Kingdom
  • Wolverhampton, United Kingdom