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Alkylating Agent

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

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Adult participants who are >= 65 years old

Must not have

Prior anti-leukemic therapy for CLL or SLL

Presence of del17p or known TP53 mutation detected at a threshold of >10% VAF

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing two treatments for leukemia, one with ibrutinib and venetoclax, and the other with obinutuzumab and chlorambucil. The goal is to see which of these treatments results in better progression-free survival, as assessed by an independent review committee.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include diarrhea, bleeding problems, infections due to low white blood cell counts, fatigue, nausea, and potentially serious complications like tumor lysis syndrome where cancer cells break down quickly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received treatment for CLL or SLL before.

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

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I have brain involvement or suspected aggressive cancer transformation.

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I have a known bleeding disorder, like von Willebrand's or hemophilia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Complete Response Rate (CRR)

Duration of Response (DOR)

Minimal Residual Disease (MRD) Negative Rate

+11 more

Other study objectives

Overall Response Rate (ORR) (Subsequent Therapy Phase)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~2060

Venetoclax

2019

Completed Phase 3

~2240