← Back to Search

Monoclonal Antibodies

Umbralisib for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Led By John Allan, MD
Research Sponsored by Weill Medical College of Cornell University
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 1 year and 4 months
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to see if it is effective and safe in treating patients with CLL who have progressed after treatment with a BTK inhibitor or a BCL-2 inhibitor.

Eligible Conditions
  • Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year and 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year and 4 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
Efficacy of Umbralisib in Combination With Ublituximab (U2) as Measured by Overall Response Rate (ORR) in Patients With CLL Who Have Progressed on a BTKi or BCL-2 Inhibitor
Secondary outcome measures
Complete Remission Rate as Measured by the Number of Subjects Who Achieve Complete Response as Their Best Response
Duration of Response
Safety of Umbralisib in Combination With Ublituximab (U2) as Measured by the Percentage of Subjects Who Experience 1 or More Adverse Events

Side effects data

From 2022 Phase 2 trial • 21 Patients • NCT03364231
50%
Diarrhoea
50%
Nausea
38%
Dizziness
25%
Anaemia
25%
Asthenia
25%
Alanine aminotransferase increased
25%
Aspartate aminotransferase increased
25%
Fatigue
25%
Oedema peripheral
25%
Hypertension
25%
Oropharyngeal pain
25%
Decreased apetite
25%
Abdominal distension
25%
Abdominal pain
25%
Back pain
13%
Feeling abnormal
13%
Dysgeusia
13%
Colitis
13%
Hypercholesterolaemia
13%
Migraine
13%
Hypermagnesaemia
13%
Hypokalaemia
13%
Hyperglycemia
13%
Dyspneoa
13%
Tachycardia
13%
Vomiting
13%
Contusion
13%
Pyrexia
13%
Throat irritation
13%
Blood alkaline phosphatase increased
13%
Seasonal allergy
13%
Gout
13%
Hypernatraemia
13%
Urinary incontinence
13%
Upper airway cough syndrome
13%
Accidental overdose
13%
Blood creatinine increased
13%
Rash macular
13%
Headache
13%
Fall
13%
Hyperuricemia
13%
Foot fracture
13%
Intervertebral disc degeneration
13%
Annular elastolytic giant cell granuloma
13%
Cough
13%
Early satiety
13%
Hypomagnesaemia
13%
Arthralgia
13%
Pruritis
13%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
MZL: Umbralisib
WM: Umbralisib

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B Post BCL-2 TherapyExperimental Treatment2 Interventions
Patients who progress after BCL-2 containing regimens Patients who progress on a regimen containing both a BTKi and a BCL-2 inhibitor
Group II: Cohort A Post BTKi TherapyExperimental Treatment2 Interventions
Patients who progress after a BTKi containing regimen
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

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,527 Total Patients Enrolled
TG Therapeutics, Inc.Industry Sponsor
36 Previous Clinical Trials
5,630 Total Patients Enrolled
John Allan, MDPrincipal InvestigatorWeill Medical College of Cornell University

Frequently Asked Questions

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

What potential risks exist for people using Umbralisib?

"Umbralisib's safety has been partially established in clinical trials, thus it was given an assessment of 2. However, efficacy is yet to be proven."

Answered by AI

In what medical situations is Umbralisib most effective?

"Umbralisib is the go-to medication for treating follicular lymphoma. Other conditions that this drug can ameliorate include recurrent or refractory B-cell non-Hodgkin's Lymphoma, which has responded to at least 3 prior lines of systemic therapy and rituximab."

Answered by AI

How many volunteers are enrolled in this medical experiment?

"Affirmative, clinicaltrials.gov conveys that this medical study is presently enrolling participants. It was first listed on February 10th 2021 and has recently been updated on March 29th 2022. 24 subjects are needed from a single site to complete the trial."

Answered by AI

Could you offer any insight into the earlier studies conducted with Umbralisib?

"At present, there are 16 Umbralisib studies that have commenced with 3 trials in its final phase. Although most of these research projects take place in Louisville, Kentucky, 326 locations worldwide have enrolled patients for the trial."

Answered by AI

Has a similar medical experiment been performed previously?

"To date, Umbralisib has been examined in 16 clinical trials spread across 15 countries and 139 cities. The initial study was held seven years ago in 2014 under the sponsorship of TG Therapeutics, Inc. This phase 1 trial included 45 patients which successfully concluded their evaluation period. Subsequently, numerous other studies have commenced since then."

Answered by AI

Are there currently any opportunities to join this medical experiment?

"According to the clinicaltrials.gov website, this trial is recruiting participants as of March 29th 2022. The study was initially posted on February 10th 2021 and continues to accept new patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy
2021. "Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04149821.
~0 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top