A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma

Conditions

• Lymphoma, Follicular

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab (MPDL3280A) [TECENTRIQ] — DRUG
  Atezolizumab will be administered at a flat dose of 840 mg on Days 1 and 15 of Cycles 2 to 6, given in 28-day cycles as induction treatment and 840 mg on Days 1 and 2 of each month, given as maintenance treatment.
• Lenalidomide — DRUG
  Lenalidomide will be administered orally once daily on Days 1 to 21 of Cycles 1 to 6 (28-day cycles) during induction treatment and on Days 1 to 21 of each month during maintenance treatment. Lenalidomide will be administered at a dose of 15 or 20 mg (dose may be de-escalated to 10 mg) during induction treatment and at 10 mg during maintenance treatment. During the expansion phase, lenalidomide will be administered at the RP2D during induction treatment and at 10 mg during maintenance treatment.
• Obinutuzumab — DRUG
  Obinutuzumab will be administered by intravenous infusion at an absolute (flat) dose of 1000 mg on Days 1, 8, and 15 of the first cycle and on Day 1 of each subsequent cycle during induction treatment, and on Day 1 of every other month (i.e., every 2 months) during maintenance treatment.

Study Details

This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of induction treatment consisting of atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who achieve a complete response (CR), a partial response (PR), or stable disease at end of induction.

Key Dates

Start date

Dec 31, 2015

Status verified

Apr 2022

Primary completion

Oct 23, 2018

Completion

Oct 7, 2020

Study Design

Enrollment

38 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Atezolizumab-G-lena 15mg
  Participants were administered obinutuzumab, Atezolizumab, and 15 mg of Lenalidomide.
• Experimental: Atezolizumab-G-lena 20mg
  Participants were administered obinutuzumab, Atezolizumab, and 20 mg of Lenalidomide.

Primary Outcome Measure

Percentage of Participants Achieving Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria [ Time Frame: 6 months (up to clinical cut-off date (CCOD) of 23 October 2018) ]

Locations (5)

Find similar trials in Birmingham, AL

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