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)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

March 24, 2016

Primary Completion Date

December 15, 2021

Study Completion Date

December 15, 2021

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

Lenalidomide

All participants will receive lenalidomide oral capsules at doses of 10, 15, or 20 milligrams (mg) on Days 1 to 21 of each 28-day cycle for up to 6 Cycles in dose escalation phase followed by post-induction treatment at a dose of 10 mg once daily on Days 1 to 21 of each subsequent 28-day cycle. Post-induction lenalidomide may continue for up to 12 months until disease progression or unacceptable toxicity for participants with R/R FL and up to 6 months until disease progression or unacceptable toxicity for participants with R/R DLBCL.

DRUG

Obinutuzumab

Participants will receive a fixed dose of obinutuzumab, 1000 mg via intravenous (IV) infusion to be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 followed by post-induction treatment at a dose of 1000 mg via IV infusion on Day 1 of every other month for up to 24 months until disease progression or unacceptable toxicity.

DRUG

Polatuzumab Vedotin

Participants with R/R FL will receive polatuzumab vedotin via IV infusion at doses of 1.4 or 1.8 milligrams per kilogram (mg/kg) on Day 1 of each 28-day cycle for up to 6 months during induction treatment. Participants wit R/R DLBCL will receive polatuzumab vedotin via IV infusion at dose 1.8 mg/kg on Day 1 of each 28-day cycle for up to 6 months during induction treatment.

DRUG

Rituximab

Participants will receive a fixed dose of rituximab, 375 mg/m\^2 via intravenous (IV) infusion to be given on Days 1 of Cycle 1 to 6 followed by post-induction treatment at a dose of 375 mg/m\^2 via IV infusion on Day 1 of every other month for up to 6 months, until disease progression or unacceptable toxicity.

Trial Locations (28)

10016

NYU School of Medicine, New York

28007

Hospital Gregorio Marañon, Madrid

28031

H. Universitario Leonor, Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz., Madrid

29010

Hospital Clínico Málaga, Málaga

30060

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Marietta

31008

Complejo Hospitalario de Navarra, Pamplona

31620

Clínica Universidad de Navarra, Pamplona

48201

Barbara Ann Karmanos Cancer Institute, Detroit

63110

Washington University; Wash Uni. Sch. Of Med, St Louis

65212

University of Missouri/Ellis Fischel, Columbia

75063

Rocky Mountain Cancer Centers, LLP, Irving

Texas Oncology-Tyler, Irving

78240

Texas Oncology San Antonio Medical Center, San Antonio

08908

Insititut Catala D'Oncologia, L'Hospitalet de Llobregat

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clínic. Barcelona, Barcelona

08041

Hospital Santa Creu i Sant Pau, Barcelona

Unknown

Hospital La Fe, Valencia

LS9 7TF

St James University Hospital, Leeds

LE1 5WW

University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary, Leicester

L7 8XP

Royal Liverpool University Hospital, Liverpool

EC1M 6BQ

Barts Hospital; Institute of Cancer, London

W1G 6AD

Sarah Cannon Research Institute, London

ME16 9QQ

Maidstone & Tonbridge Wells Hospital; Kent Oncology Center, Maidstone

NG5 1PB

Nottingham University Hospitals NHS Trust - City Hospital, Nottingham

RM7 0AG

Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital, Romford

WV10 0QP

The Royal Wolverhampton Hospitals NHS Trust; Department of Haematology, Wolverhampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02600897 - 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) | Biotech Hunter | Biotech Hunter