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)

Active:	No
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT02600897
Trial Phases:	Phase I Phase II	Protocol IDs:	NCT02600897 (primary) 2015-001999-22 GO29834
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Hoffmann-La Roche
NCI Full Details:	http://clinicaltrials.gov/show/NCT02600897

Summary

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.

Objectives

Current Primary Outcome Measures ^ICMJE (submitted: November 5, 2015)	Percentage of participants with CR, determined by an independent review committee (IRC) on the basis of positron emission tomography (PET) and computed tomography (CT) scans [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT02600897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 5, 2015)	Percentage of participants with adverse events [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ] Percentage of participants with dose-limiting toxicities (DLTs) [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: Yes ] Percentage of participants with CR, determined by the investigator on the basis of PET and CT scans [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ] Percentage of participants with CR, determined by the investigator on the basis of CT scans alone [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ] Percentage of participants with objective response, determined by an IRC on the basis of PET and CT scans [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ] Percentage of participants with objective response, determined by the investigator on the basis of PET and CT scans [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ] Percentage of participants with objective response, determined by an IRC on the basis of CT scans alone [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ] Percentage of participants with objective response, determined by the investigator on the basis of CT scans alone [ Time Frame: Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks) ] [ Designated as safety issue: No ] Observed serum obinutuzumab concentration [ Time Frame: Pre-dose and/or 30 minutes post-dose on Day 1 of Cycles 1, 2, 4, and 6 during induction; pre-dose on Day 1 of Months 1, 7, 13, and/or 19 during the post-induction phase; then up to 2 years after last dose as available (maximum 5 years) ] [ Designated as safety issue: No ] Observed serum and plasma polatuzumab vedotin concentration [ Time Frame: Pre-dose and/or 30 minutes post-dose on Days 1, 8, and 15 of Cycle 1; pre-dose and/or 30 minutes post-dose on Day 1 of Cycles 2, 4, and 6 during induction; then up to 2 years after last dose as available (maximum 5 years) ] [ Designated as safety issue: No ] Observed plasma lenalidomide concentration [ Time Frame: Pre-dose and/or 0.5, 1, 2, 4, and 8 hours post-dose on Days 1 and 15 of Cycle 1 and on Day 1 of Cycle 6 (maximum 5 years) ] [ Designated as safety issue: No ] Percentage of participants with human anti-human antibodies (HAHAs) to obinutuzumab [ Time Frame: Pre-dose on Day 1 of Cycles 1 and 6 during induction; then up to 2 years after last dose as available (maximum 5 years) ] [ Designated as safety issue: No ] Percentage of participants with anti-therapeutic antibodies (ATAs) to polatuzumab vedotin [ Time Frame: Pre-dose on Day 1 of Cycles 1, 2, and 4 during induction; then up to 2 years after last dose as available (maximum 5 years) ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Austell
1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com

Doctors:

Sujatha Hariharan MD

Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen
200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton
157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD

Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville
100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com

Doctors:

Satyen R. Mehta MD

Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville
6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com

Doctors:

Navin P. Wadehra MD

Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper
1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com

Doctors:

Curtis R. Miles MD

Northwest Georgia Oncology Centers - Marietta
340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060
770-281-5131
www.ngoc.com

Northwest Georgia Oncology Centers - Paulding
144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Doctors:

Kathleen A. Long MD

Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica
705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

Doctors:

Randall E. Pierce MD

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