Phase 2
Completed N=114
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)
Source: ClinicalTrials.gov NCT02600897 ↗Enrolled (actual)
114
Serious AEs
52.2%
Results posted
Dec 2023
Primary outcomePrimary: Percentage of Participants With Dose-Limiting Toxicities (DLTs) — 0.0; 50.0; 0.0; 0.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Dose-Limiting Toxicities (DLTs) |
0.0; 50.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Percentage of Participants With Complete Response (CR) at End of Induction (EOI), Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography (PET) and Computed Tomography (CT) Scans |
66.7; 0.0; 60.0; 38.5 | — |
| SECONDARY Percentage of Participants With CR at EOI, Determined by the Investigator on the Basis of PET-CT Scans |
66.7; 0.0; 60.0; 33.3 | — |
| SECONDARY Percentage of Participants With CR at EOI, Determined by the IRC on the Basis of CT Scans Alone |
16.7; 0.0; 31.4; 12.5 | — |
| SECONDARY Percentage of Participants With CR at EOI, Determined by Investigator on the Basis of CT Scans Alone |
16.7; 0.0; 29.7; 28.1 | — |
| SECONDARY Percentage of Participants With Objective Response (OR) at EOI, Determined by the IRC on the Basis of PET-CT Scans |
100.0; 10.0; 72.50; 46.20 | — |
| SECONDARY Percentage of Participants With Objective Response at EOI, Determined by Investigator on the Basis of PET-CT Scans |
100.0; 10.0; 80.0; 46.20 | — |
| SECONDARY Percentage of Participants With Objective Response at EOI, Determined by the IRC on the Basis of CT Scans Alone |
100.0; 12.5; 91.4; 53.1 | — |
| SECONDARY Percentage of Participants With Objective Response, Determined by the Investigator on the Basis of CT Scans Alone |
100.0; 11.1; 89.2; 59.4 | — |
| SECONDARY Percentage of Participants With Best Response of CR or PR, Determined by the Investigator on the Basis of CT Scans Alone |
100.0; 50.0; 90.0; 79.5 | — |
| SECONDARY Observed Serum Obinutuzumab Concentration |
NA; NA; NA; NA; NA; 394 | — |
| SECONDARY Observed Serum Rituximab Concentration |
NA; NA; NA; NA; 151; 203 | — |
| SECONDARY Serum Concentration of Polatuzumab Vedotin Analyte: Total Antibody |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Plasma Concentration of Polatuzumab Vedotin Analyte: Antibody-conjugated MMAE (acMMAE) |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Observed Plasma Lenalidomide Concentration |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Number of Participants With Human Anti-human Antibodies (HAHAs) to Obinutuzumab |
0; 0; 0; 0; 3; 0 | — |
| SECONDARY Number of Participants With Human Anti-chimeric Antibodies (HACAs) to Rituximab |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Anti-therapeutic Antibodies (ATAs) to Polatuzumab Vedotin |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to (>/=) 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- For obinutuzumab in combination with polatuzumab vedotin and lenalidomide (G + Pola + Len) treatment group: R/R FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator
- For rituximab in combination with polatuzumab vedotin and lenalidomide (R + Pola + Len) treatment group: R/R DLBCL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody in patients who are not eligible for autologous stem-cell transplantation or who have experienced disease progression following treatment with high-dose chemotherapy plus autologous stem-cell transplantation
- Histologically documented CD20-positive B-cell lymphoma as determined by the local laboratory
- fluorodeoxyglucose (FDG)-avid lymphoma (i.e., positron emission tomography (PET)-positive lymphoma)
- At least one bi-dimensionally measurable lesion
- Agreement to remain abstinent or use adequate contraception, among women or men of childbearing potential
Exclusion Criteria
- Grade 3b follicular lymphoma
- History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)
- Known CD20-negative status at relapse or progression
- Central nervous system (CNS) lymphoma or leptomeningeal infiltration
- Prior allogeneic stem-cell transplantation (SCT), or autologous SCT within 100 days prior to Day 1 of Cycle 1
- Current use of systemic immunosuppressant(s), or prior anti-cancer therapy to include: lenalidomide, fludarabine, or alemtuzumab within 12 months; radioimmunoconjugate within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
- Active infection
- Positive for human immunodeficiency virus (HIV) or hepatitis B or C
- Receipt of a live virus vaccine within 28 days prior to Day 1 of Cycle 1
- Poor hematologic, renal, or hepatic function
- Pregnant or lactating women
- Life expectancy less than (<) 3 months
Data sourced from ClinicalTrials.gov (NCT02600897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.