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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

GLOW 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.Check my eligibility

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.See study design

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.

GLOW Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 65 years old or older.

GLOW Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

Complete Response Rate (CRR)

Duration of Response (DOR)

Minimal Residual Disease (MRD) Negative Rate

+11 more

Other outcome measures

Overall Response Rate (ORR) (Subsequent Therapy Phase)

GLOW 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 3

~1880

Venetoclax

2019

Completed Phase 3

~1990

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,097 Total Patients Enrolled

Pharmacyclics LLC.Industry Sponsor

113 Previous Clinical Trials

13,609 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,694 Total Patients Enrolled

Media Library

Chlorambucil (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03462719 — Phase 3

Chronic B-Cell Leukemia Research Study Groups: Treatment Arm B: Chlorambucil and Obinutuzumab (G-Clb), Treatment Arm A: Ibrutinib and Venetoclax (I+VEN)

Chronic B-Cell Leukemia Clinical Trial 2023: Chlorambucil Highlights & Side Effects. Trial Name: NCT03462719 — Phase 3

Chlorambucil (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03462719 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

After a patient has undergone initial therapy, how effective is Ibrutinib in preventing disease progression?

"Given that this is a Phase 3 trial - meaning that there is both efficacy and safety data from multiple rounds of testing - our team has rated the safety of Ibrutinib (as Subsequent Therapy) as a 3."

Answered by AI

Are there still spots open for volunteers in this clinical trial?

"Unfortunately, this particular clinical trial is not looking for new participants as of October 5th, 2022, as per clinicaltrials.gov. This study was initially posted on April 17th, 2018. Although this particular trial has completed recruitment, there are 1,982 other trials that are actively recruiting."

Answered by AI

Is ibrutinib a common treatment in follow-up care?

"As of now, there are 418 Ibrutinib (as Subsequent Therapy) studies in progress with 55 of them in Phase 3. With many of the Ibrutinib (as Subsequent Therapy) trials nearing their end in Edmonton, Alberta, there are a total of 13,287 locations running clinical trials for Ibrutinib (as Subsequent Therapy)."

Answered by AI

What has ibrutinib been most successful in treating?

"Ibrutinib (as Subsequent Therapy) is often given to patients that suffer from indolent lymphoma. It is also an effective treatment for malt lymphoma, hodgkin disease, and waldenstrom macroglobulinemia."

Answered by AI

What are the Principal Investigators hoping to learn from this research?

"The primary outcome being measured in this study is Progression-Free Survival (PFS), which will be followed over the course of Up to 2 years 10 months. Additionally, this trial will observe secondary outcomes including Time to Worsening Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30) and Complete Response Rate (CRR). EORTC QLQ-C30 is a 30 item scale that covers 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. The primary outcome being measured in this study is Pro"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

2018. "A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03462719.

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