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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

133

Participants

Timeline

Start Date

March 9, 2016

Primary Completion Date

August 4, 2022

Study Completion Date

August 4, 2022

Conditions
Non-Hodgkin's Lymphoma
Interventions
DRUG

Obinutuzumab

Participants will receive a fixed dose of obinutuzumab, 1000 milligrams (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. Cycle length will be 21 days. For eligible participants, post-induction treatment may be given at a dose of 1000 mg via IV infusion on Day 1 of every other month (starting from Month 2) for up to 24 months, until disease progression or unacceptable toxicity.

DRUG

Rituximab

Participants will receive a fixed dose of rituximab, 375 milligrams per square meter (mg/m\^2) via IV infusion to be given on Day 1 of Cycles 1 to 6. Cycle length will be 21 days. For eligible participants, post-induction treatment may be given at a dose of 375 mg/m\^2 via IV infusion on Day 1 of every other month (starting from Month 2) for up to 8 months, until disease progression or unacceptable toxicity.

DRUG

Polatuzumab Vedotin

Participants will receive polatuzumab vedotin via IV infusion at doses of 1.4 or 1.8 milligrams per kilogram (mg/kg) (for FL), and 1.8 mg/kg (for DLBCL) on Day 1 of each 21-day cycle for up to 18 weeks during induction treatment. Polatuzumab vedotin will not be given during the post-induction period.

DRUG

Venetoclax

Participants will receive venetoclax film-coated tablets at doses of 200, 400, 600, or 800 mg (for FL), and 400, 600, or 800 mg (for DLBCL) on Days 1 to 21 of each 21-day cycle. Post-induction venetoclax may continue for up to 8 months, until disease progression or unacceptable toxicity.

Trial Locations (23)

2065

Royal North Shore Hospital; Haematology Department, St Leonards

2298

Calvary Mater Newcastle, Waratah

3051

Peter MacCallum Cancer Center, North Melbourne

4102

Princess Alexandra Hospital, Woolloongabba

5011

The Queen Elizabeth Hospital, Adelaide

7000

Royal Hobart Hospital, Hobart

10126

A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia, Turin

14263

Roswell Park Cancer Inst., Buffalo

19111

Fox Chase Cancer Center, Philadelphia

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

24127

Papa Giovanni Hospital XXIII, Bergamo

28100

SCDU Ematologia, Novara

30322

Emory Univ Winship Cancer Inst, Atlanta

33028

Memorial Healthcare System, Pembroke

40202

University of Louisville Hospital; The James Graham Brown Cancer Center, Louisville

47014

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola

47923

Ospedale Infermi U.O. Ematologia, Rimini

48121

UO Ematologia, Ospedale S.Maria delle Croci, Ravenna

76508

Scott and White, Temple

85719

University of Arizona Cancer Center, Tucson

06520

Yale Cancer Center, New Haven

48109-0934

University of Michigan, Ann Arbor

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02611323 - A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL) | Biotech Hunter | Biotech Hunter