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Monoclonal Antibodies

Ublituximab for Chronic Lymphocytic Leukemia (ULTRA-V Trial)

Q: What are some of the conditions that Ublituximab has been shown to help?

<p>Lymphomas such as <a href="https://www.withpower.com/clinical-trials/follicular-lymphoma">follicular lymphoma</a>, small lymphocytic lymphoma, and others can be helped with ublituximab.</p>

Phase 2 & 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 up to 43.2 months

Awards & highlights

ULTRA-V Trial Summary

This trial is studying the combination of ublituximab, umbralisib, and venetoclax to see how well it works compared to ublituximab and umbralisib in treating patients with CLL.

Eligible Conditions

Chronic Lymphocytic Leukemia
Lymphoma

ULTRA-V Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 43.2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 43.2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 43.2 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

Phase 2: Complete Response (CR) Rate as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Criteria

Phase 2: Overall Response Rate (ORR) Per iwCLL 2018 Criteria

Phase 3: Progression-Free Survival (PFS) Per iwCLL 2018 Criteria

Secondary outcome measures

Minimal Residual Disease (MRD) Negativity Rate

Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)

Phase 2: Duration of Response (DOR) Per iwCLL 2018 Criteria

+4 more

ULTRA-V Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V)Experimental Treatment3 Interventions

Participants were administered ublituximab, 150 mg, IV infusion on Day 1, 750 mg on Day 2, 900 mg on Days 8 and 15 of Cycle 1, followed by 900 mg on Day 1 of Cycles 2-6, 9,12, and 15; umbralisib, 800 mg, oral tablet, QD through Cycles 1-15; venetoclax, oral tablet, QD, 20 mg on Days 1-7, 50 mg on Days 8-14, 100 mg on Days 15-21, 200 mg on Days 22-28 of Cycle 4, followed by 400 mg on Days 1-28 of Cycles 5-15 (1 Cycle = 28 days).

Group II: Phase 3: Ublituximab + Umbralisib (U2)Experimental Treatment2 Interventions

Participants were administered ublituximab, 150 mg, IV infusion on Day 1, 750 mg on Day 2, 900 mg on Days 8 and 15 of Cycle 1, followed by 900 mg on Day 1 of Cycles 2-6, then every three cycles along with umbralisib, 800 mg, oral tablet, QD (1 Cycle = 28 days) from Cycle 1 until disease progression, unacceptable toxicity, or withdrawal from the study.

Group III: Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V)Experimental Treatment3 Interventions

Participants were administered ublituximab, 150 milligrams (mg), intravenous (IV) infusion on Day 1, 750 mg on Day 2, 900 mg on Days 8 and 15 of Cycle 1, followed by 900 mg on Day 1 of Cycles 2-6; umbralisib, 800 mg, oral tablet, once daily (QD) through Cycles 1-24; venetoclax, oral tablet, QD, 20 mg on Days 1-7, 50 mg on Days 8-14, 100 mg on Days 15-21, 200 mg on Days 22-28 of Cycle 4, followed by 400 mg on Days 1-28 of Cycles 5-24. MRD positive participants were administered umbralisib, 800 mg, oral tablet, QD, on Days 1-28 from Cycle 25 onwards (1 Cycle = 28 days), until disease progression, unacceptable toxicity, or withdrawal from the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Umbralisib

2015

Completed Phase 2

~60

Ublituximab

2017

Completed Phase 3

~2090

Venetoclax

2019

Completed Phase 3

~1990

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

TG Therapeutics, Inc.Lead Sponsor

36 Previous Clinical Trials

5,360 Total Patients Enrolled

Frequently Asked Questions

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

Is this trial being conducted at different locations within the state?

"This study is currently enrolling patients at 48 different clinical sites. Some of these locations include Nashville, Huntsville and Niles. There are also 48 other sites where you may be able to enroll. To limit travel, please select the site that is closest to your location."

Answered by AI

Can you provide some context for this Ublituximab research?

"Ublituximab was first researched in 2014 at M D Anderson Cancer Center. As of now, there are a total of 67 completed trials. There are also 240 active trials, a large portion of which are taking place in Nashville, Tennessee."

Answered by AI

What are some of the conditions that Ublituximab has been shown to help?

"Lymphomas such as follicular lymphoma, small lymphocytic lymphoma, and others can be helped with ublituximab."

Answered by AI

How many individuals are presently enrolled in this study?

"This particular clinical trial is not looking for new patients to enroll at the moment. The study was first made public on May 16th, 2019 and was last updated on October 19th, 2020. For those who are interested in other studies, there are 1574 clinical trials related to small lymphocytic lymphoma and 240 trials involving Ublituximab that are actively recruiting patients."

Answered by AI

Are there any more spots left for people who want to join this experiment?

"According to the information available on clinicaltrials.gov, this particular clinical trial is not recruiting patients at the moment. The trial was first posted on May 16th, 2019 and was updated as recently as October 19th, 2020. There are, however, 1814 other studies that are actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)

2019. "Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03801525.