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Parent Study Arm B for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Research Sponsored by TG Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 78 months
Awards & highlights

Study Summary

This study is evaluating whether a new drug combination can improve the survival of people with cancer.

Eligible Conditions
  • Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 78 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 78 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR) Rate Per iwCLL Criteria
Duration of Response (DOR)
Overall Response Rate (ORR) as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria
+1 more
Secondary outcome measures
Minimal Residual Disease (MRD) Negativity Rate
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Parent Study Arm DExperimental Treatment2 Interventions
Participants from Arm D of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Group II: Parent Study Arm CExperimental Treatment2 Interventions
Participants from Arm C of the parent trial (UTX-TGR-304) received ublituximab, 900 mg, IV, on Day 1 of Cycles 1-6 (cycle length=28 days), and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Group III: Parent Study Arm BExperimental Treatment2 Interventions
Participants from Arm B of the parent trial (UTX-TGR-304) received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ublituximab
2017
Completed Phase 3
~2090
Umbralisib
2015
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

TG Therapeutics, Inc.Lead Sponsor
36 Previous Clinical Trials
5,521 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304
2016. "A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02656303.
~13 spots leftby Apr 2025
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