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

Status
Approved-not yet active
Cancer Type
Lymphoma
Trial Phase
Phase I
Eligibility
18+, Male and Female
Study Type
NCD ID
NCT02600897
Protocol IDs
NCT02600897 (primary)
2015-001999-22
GO29834
Study Sponsor
Hoffmann-La Roche

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 FL or DLBCL. Participants with FL who achieve complete response (CR), partial response (PR), or stable disease (SD) at the end of induction therapy will receive post-induction treatment with obinutuzumab and lenalidomide, and participants with DLBCL who achieve CR or PR at the end of induction will also be eligible for post-induction treatment.

Objectives

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 ]
Same as current
Complete list of historical versions of study NCT02600897 on ClinicalTrials.gov Archive Site
  • 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 ]
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

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
Georgia CORE

 

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