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Alkylating agents

TGR-1202 for Chronic Lymphocytic Leukemia (UNITY-CLL Trial)

Phase 3
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 every 12 weeks up to 2 years
Awards & highlights

UNITY-CLL Trial Summary

This trial is testing a new combination of drugs for CLL patients compared to the current standard of care.

Eligible Conditions
  • Chronic Lymphocytic Leukemia

UNITY-CLL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks up to 2 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
Secondary outcome measures
Overall Response Rate

UNITY-CLL Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Ublituximab + TGR-1202Experimental Treatment2 Interventions
Ublituximab: IV infusion dose on Days 1, 8 and 15 followed by maintenance infusions TGR-1202: Fixed oral daily dose
Group II: UblituximabExperimental Treatment1 Intervention
- Ublituximab: IV infusion dose on Days 1, 8 and 15 followed by maintenance infusions
Group III: TGR-1202Experimental Treatment1 Intervention
- TGR-1202: Fixed oral daily dose
Group IV: Obinutuzumab + ChlorambucilActive Control2 Interventions
Obinutuzumab: IV infusion dose on Days 1, 8 and 15 in Cycle 1 followed by Day 1 infusion in Cycles 2 - 6 Chlorambucil: Oral dose on Days 1 and 15 of Cycles 1 - 6
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TGR-1202
2015
Completed Phase 3
~810
Ublituximab
2017
Completed Phase 3
~2090

Find a Location

Who is running the clinical trial?

TG Therapeutics, Inc.Lead Sponsor
36 Previous Clinical Trials
5,028 Total Patients Enrolled

Frequently Asked Questions

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

Could you please provide a brief overview of other research done on Ublituximab?

"There are one hundred and twenty-three studies underway for Ublituximab; with 23 of those in the third stage of clinical trials. Although a majority of these trials take place in Boston, Massachusetts, there are 5292 locations running trials for this treatment globally."

Answered by AI

Can people still sign up for this experiment?

"No, this specific trial is not currently looking for candidates according to the latest update on clinicaltrials.gov from October 19th, 2022. This does not mean there are no other trials recruiting, in fact, there are 1698 medical studies presently accepting participants."

Answered by AI

What are some of the main indications for ublituximab?

"Lymphoma patients may respond well to ublituximab, which is also being trialed for its efficacy against indolent lymphoma, malt lymphoma, and hodgkin disease."

Answered by AI

Has this research been conducted before?

"Ublituximab's journey from research to drug approval spanned 7 years and began in 2012. That year, Janssen Research & Development, LLC sponsored the first study into Ublituximab which involved 232 participants. The next milestone for Ublituximab was Phase 3 drug approval which it received after its first study. As of today, there are 123 live studies being conducted with Ublituximab across 51 countries and 1019 cities"

Answered by AI

How many people are being recruited for this research project?

"Unfortunately, this particular trial has stopped recruiting patients. The study was first made available on November 19th, 2015 but the last update was on October 19th, 2022. There are other trials underway though – 1575 for leukemia and 123 specifically for Ublituximab."

Answered by AI

Are there any life-threatening risks associated with Ublituximab?

"Ublituximab has undergone Phase 3 trials, meaning that there is evidence of its efficacy and multiple rounds of data supporting its safety. Consequently, our team rates it a 3 in terms of safety."

Answered by AI

In how many medical facilities is this research being conducted?

"100 clinical trial sites are currently enrolling patients for this study. While some cities, such as Detroit, Camp Hill and Wauwatosa have multiple locations, other participating towns only have a single site. It may be beneficial to select the location nearest you in order to limit travel if you choose to participate."

Answered by AI
~64 spots leftby Apr 2025