A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

November 29, 2013

Primary Completion Date

December 19, 2018

Study Completion Date

December 19, 2018

Conditions
Lymphoma, Non Hodgkin
Interventions
DRUG

Cyclophosphamide

Cyclophosphamide will be administered at 750 milligrams per square meter (mg/m\^2) IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.

DRUG

Doxorubicin

Doxorubicin will be administered at 50 mg/m\^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.

DRUG

Obinutuzumab

Obinutuzumab will be administered at 1000 milligrams (mg) IV on Cycle 1 Days 1, 8, and 15 and on Day 1 of Cycles 3-8.

DRUG

Polatuzumab Vedotin

Polatuzumab vedotin will be administered at escalating doses (at a starting dose of 1 mg/kg) IV every 3 weeks, for 6 or 8 cycles.

DRUG

Prednisolone

Prednisolone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles. Prednisone at 100 mg orally from Day -7 to Day -1 may be given at the discretion of the treating investigator physician.

DRUG

Prednisone

Prednisone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles. Prednisone at 100 mg orally from Day -7 to Day -1 may be given at the discretion of the treating investigator physician.

DRUG

Rituximab

Rituximab will be administered at 375 mg/m\^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.

Trial Locations (11)

24014

Blue Ridge Cancer Care, Roanoke

35233

The University of Alabama at Birmingham, Birmingham

59037

Hopital Claude Huriez - CHU Lille; Service des maladies du sang, Lille

63110

Washington University; Pediatrics, St Louis

69495

Centre Hospitalier Lyon Sud; Hematolgie, Pierre-Bénite

76038

Centre Henri Becquerel; Hematologie, Rouen

85234

Banner MD Anderson Cancer Center, Greeley

94010

Hopital Henri Mondor, Unite Hemopathies lymphoides, Créteil

97210

Northwest Cancer Specialists, Portland

97239

Oregon Health and Science University, Portland

97477

Willamette Valley Clinical Studies; Cancer Institute, Springfield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY

NCT01992653 - A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma | Biotech Hunter | Biotech Hunter