Clinical trial

A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Polatuzumab Vedotin and Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Name

GO29834

Description

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.

Trial arms

Trial start

2016-03-24

Estimated PCD

2021-12-15

Trial end

2021-12-15

Status

Completed

Phase

Early phase I

Treatment

Lenalidomide

All participants will receive lenalidomide oral capsules at doses of 10, 15, or 20 milligrams (mg) on Days 1 to 21 of each 28-day cycle for up to 6 Cycles in dose escalation phase followed by post-induction treatment at a dose of 10 mg once daily on Days 1 to 21 of each subsequent 28-day cycle. Post-induction lenalidomide may continue for up to 12 months until disease progression or unacceptable toxicity for participants with R/R FL and up to 6 months until disease progression or unacceptable toxicity for participants with R/R DLBCL.

Arms:

Dose-escalation Cohort: DLBCL, Dose-escalation Cohort: FL, Expansion Cohort: DLBCL, Expansion Cohort: FL

Obinutuzumab

Participants will receive a fixed dose of obinutuzumab, 1000 mg via intravenous (IV) infusion to be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 followed by post-induction treatment at a dose of 1000 mg via IV infusion on Day 1 of every other month for up to 24 months until disease progression or unacceptable toxicity.

Arms:

Dose-escalation Cohort: FL, Expansion Cohort: FL

Polatuzumab Vedotin

Participants with R/R FL will receive polatuzumab vedotin via IV infusion at doses of 1.4 or 1.8 milligrams per kilogram (mg/kg) on Day 1 of each 28-day cycle for up to 6 months during induction treatment. Participants wit R/R DLBCL will receive polatuzumab vedotin via IV infusion at dose 1.8 mg/kg on Day 1 of each 28-day cycle for up to 6 months during induction treatment.

Arms:

Dose-escalation Cohort: DLBCL, Dose-escalation Cohort: FL

Rituximab

Participants will receive a fixed dose of rituximab, 375 mg/m\^2 via intravenous (IV) infusion to be given on Days 1 of Cycle 1 to 6 followed by post-induction treatment at a dose of 375 mg/m\^2 via IV infusion on Day 1 of every other month for up to 6 months, until disease progression or unacceptable toxicity.

Arms:

Dose-escalation Cohort: DLBCL, Expansion Cohort: DLBCL

Size

114

Primary endpoint

Percentage of Participants With Dose-Limiting Toxicities (DLTs)

Day 1 of Cycle 1 to Day 1 of Cycle 2 (1 cycle = 28 days) in dose-escalation phase

Percentage of Participants With Adverse Events (AEs)

From study start up to end of study (Up to a maximum of 69 months)

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

6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 114, 'type': 'ACTUAL'}}

Updated at

2023-12-26

1 organization

4 products

2 indications

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