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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

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



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



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



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



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



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



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



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

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