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)
Completed · Phase 1/Phase 2
Conditions studied: Relapsed or Refractory Follicular Lymphoma, Relapsed or Refractory Diffuse Large B-Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT02600897
- Run by
- Hoffmann-La Roche
- People needed
- 114
- Starts
- 2016-03-24
- Expected to finish
- 2021-12-15
- Last updated by the study team
- 2023-12-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital — Marietta, Georgia, United States
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
- University of Missouri/Ellis Fischel — Columbia, Missouri, United States
- Washington University; Wash Uni. Sch. Of Med — St Louis, Missouri, United States
- NYU School of Medicine — New York, New York, United States
- Rocky Mountain Cancer Centers, LLP — Irving, Texas, United States
- Texas Oncology-Tyler — Irving, Texas, United States
- Texas Oncology San Antonio Medical Center — San Antonio, Texas, United States
- Insititut Catala D'Oncologia — L'Hospitalet de Llobregat, Barcelona, Spain
- Hospital Clínico Málaga — Málaga, Malaga, Spain
- Complejo Hospitalario de Navarra — Pamplona, Navarre, Spain
- Clínica Universidad de Navarra — Pamplona, Navarre, Spain
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
- Hospital Clínic. Barcelona — Barcelona, Spain
- Hospital Santa Creu i Sant Pau — Barcelona, Spain
- Hospital Gregorio Marañon — Madrid, Spain
- H. Universitario Leonor — Madrid, Spain
- Hospital Universitario Fundacion Jimenez Diaz. — Madrid, Spain
- Hospital La Fe — Valencia, Spain
- St James University Hospital — Leeds, United Kingdom
- University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary — Leicester, United Kingdom
- Royal Liverpool University Hospital — Liverpool, United Kingdom
- Barts Hospital; Institute of Cancer — London, United Kingdom
- Sarah Cannon Research Institute — London, United Kingdom
- Maidstone & Tonbridge Wells Hospital; Kent Oncology Center — Maidstone, United Kingdom
Full record on ClinicalTrials.gov
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