A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Part of paid clinical trials in La Jolla, California.

Sponsor
Pharmacyclics LLC.
Study ID
NCT02264574
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib will be supplied as 140 mg hard gelatin capsules for oral (PO) administration.
  • Obinutuzumab — DRUG
    Obinutuzumab will be supplied as 1000 mg/40 mL solution in a single-use vial for intravenous (IV) administration
  • Chlorambucil — DRUG
    Chlorambucil will be supplied as 2 mg film-coated tablets for oral (PO) administration

Study Details

The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.

Key Dates

Start date
Oct 6, 2014
Status verified
Aug 2020
Primary completion
Mar 26, 2018
Completion
Sep 3, 2019

Study Design

Enrollment
229 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IBR + OB
    Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity. Intravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.
  • Experimental: CLB + OB
    Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity. Intravenous obinutuzumab given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.

Primary Outcome Measure

Primary Analysis: Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 30 [ Time Frame: Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]). ]

Locations (8)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 0241La JollaCalifornia--
Site Reference ID/Investigator# 0844Fort MyersFlorida--
Site Reference ID/Investigator# 0763West Palm BeachFlorida--
Site Reference ID/Investigator# 071LouisvilleKentucky--
Site Reference ID/Investigator# 0712Las VegasNevada--
Site Reference ID/Investigator# 0845CincinnatiOhio--
Site Reference ID/Investigator# 0868ChattanoogaTennessee--
Site Reference ID/Investigator# 0123NashvilleTennessee--

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