Ibrutinib + Venetoclax vs Chlorambucil + Obinutuzumab for Chronic B-Cell Leukemia
(GLOW Trial)

Recruiting in Palo Alto (17 mi)

+109 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).

Eligibility Criteria

This trial is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who need treatment and have not had previous anti-leukemic therapy. Participants should be over 65, or 18-64 with certain health conditions, and able to perform daily activities with minimal help.

Inclusion Criteria

Adult participants who are 18 to 64 years old and have at least 1 of the following: CIRS score > 6, CrCl estimated < 70 mL/min using Cockcroft-Gault equation, Diagnosis of CLL or SLL meeting iwCLL criteria, Measurable nodal disease by CT, ECOG PS Grade <= 2, Active CLL/SLL requiring treatment per iwCLL criteria

I am 65 years old or older.

Exclusion Criteria

I have received treatment for CLL or SLL before.

My cancer has a specific genetic change (del17p or TP53 mutation).

I have not had major surgery in the last 4 weeks.

+2 more

Participant Groups

The study compares two treatments: Ibrutinib plus Venetoclax versus Chlorambucil plus Obinutuzumab in patients with CLL/SLL. It aims to see which combination is better at stopping the disease from progressing without getting worse.

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Arm A: Ibrutinib and Venetoclax (I+VEN)Experimental Treatment3 Interventions

Participants will initially receive ibrutinib (420 mg \[milligrams\]/day) for 3 cycles. Venetoclax dose ramp up (from 20 to 400 mg over 5 weeks) will begin at Cycle 4 and the combination of ibrutinib and venetoclax will be given for 12 cycles (each cycle is equivalent to 28 days). Participants who subsequently develop progressive disease may enter to Subsequent Therapy Phase to receive single-agent ibrutinib until disease progression or unacceptable toxicity.

Group II: Treatment Arm B: Chlorambucil and Obinutuzumab (G-Clb)Active Control3 Interventions

Participants will receive chlorambucil and obinutuzumab (G-Clb) for 6 cycles. Participants will receive obinutuzumab, 1000 mg intravenously (IV) on Days 1, 8 and 15 of Cycle 1, and on Day 1 of Cycles 2 to 6 and chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight, on Days 1 and 15 of Cycles 1 to 6. Participants who subsequently develop progressive disease may enter to Subsequent Therapy Phase to receive single-agent ibrutinib until disease progression or unacceptable toxicity.