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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

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%
Alanine aminotransferase increased
25%
Asthenia
25%
Anaemia
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
~1490

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,064 Previous Clinical Trials
1,319,185 Total Patients Enrolled
TG Therapeutics, Inc.Industry Sponsor
38 Previous Clinical Trials
6,864 Total Patients Enrolled
John Allan, MDPrincipal InvestigatorWeill Medical College of Cornell University
~0 spots leftby Jul 2025
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