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Ublituximab 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 approximately 34 months

Awards & highlights

Study Summary

This trial is looking at whether adding ublituximab and umbralisib to current treatment for CLL will improve the rate of MRD negativity.

Eligible Conditions

Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 34 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 34 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 34 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

Rate of Undetected Minimal Residual Disease (U-MRD)

Secondary outcome measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)

Overall Response Rate (ORR)

Trial Design

3Treatment groups

Experimental Treatment

Group I: ublituximab + umbralisib + venetoclaxExperimental Treatment3 Interventions

Participants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; venetoclax oral tablet daily (1 Cycle = 28 days).

Group II: ublituximab + umbralisib + ibrutinibExperimental Treatment3 Interventions

Group III: ublituximab + umbralisib + acalabrutinibExperimental Treatment3 Interventions

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

Ibrutinib

2014

Completed Phase 3

~1880

Venetoclax

2019

Completed Phase 3

~1990

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Who is running the clinical trial?

TG Therapeutics, Inc.Lead Sponsor

36 Previous Clinical Trials

5,590 Total Patients Enrolled

Frequently Asked Questions

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

What potential risks could arise from Ublituximab usage?

"As this examination is in its second phase, there are some safety-related findings yet to be any evidences of Ublituximab's efficacy. Thus our team at Power has rated it a 2 on the 1-3 scale."

Answered by AI

How many participants are currently engaged in this research project?

"Unfortunately, no more participants are being sought for this trial. It was initially listed on the 5th of August 2019 and its last update came on the 18th of November 2022. If you're looking for other medical studies, there are presently 1,520 clinical trials actively enrolling patients with chronic lymphocytic leukemia (CLL) and 415 trials utilizing Ublituximab that accept participants."

Answered by AI

Is the current recruitment phase of this trial still accepting participants?

"The information posted on clinicaltrials.gov confirms that recruitment for this trial is not in progress at present. Though the study was initially published 8/5/2019 and last updated 11/18/2022, there are a total of 1935 other trials presently enrolling patients."

Answered by AI

What conditions can Ublituximab be employed in order to help alleviate symptoms?

"Ublituximab is a popular therapeutic agent for lymphoma. It can also prove beneficial to those with mantle cell lymphoma, waldenstrom macroglobulinemia, and refractory follicular lymphoma who have had at least one prior therapy regimen."

Answered by AI

Have there been any other investigations conducted regarding Ublituximab?

"Ublituximab was first trialled in 2011 at the National Institutes of Health Clinical Centre, located on 9000 Rockville Pike. As of today, a staggering 180 studies have been concluded and 415 are still running across numerous locations; most prominently New york City."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

2019. "Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04016805.