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Immunomodulator

Venetoclax for Chronic Lymphocytic Leukemia

Phase 1 & 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 12 months
Awards & highlights

Study Summary

This trial is testing the safety and efficacy of two different combinations of drugs to treat CLL/SLL and NHL.

Eligible Conditions
  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Determine Acceptable Adverse Events That Are Related to Treatment
Secondary outcome measures
Minimum Residual Disease (MRD)
Overall Response and Complete Remission Rate

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
White blood cell count decreased
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Electrocardiogram QT prolonged
11%
Blood creatinine increased
11%
Dermatitis
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ublituximab + Umbralisib + VenetoclaxExperimental Treatment3 Interventions
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
Group II: Ublituximab + Umbralisib + LenalidomideExperimental Treatment3 Interventions
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Umbralisib
2015
Completed Phase 2
~60
Venetoclax
2019
Completed Phase 3
~1990
Ublituximab
2017
Completed Phase 3
~2040

Find a Location

Who is running the clinical trial?

James P. Wilmot Cancer CenterOTHER
1 Previous Clinical Trials
30 Total Patients Enrolled
TG Therapeutics, Inc.Lead Sponsor
36 Previous Clinical Trials
5,553 Total Patients Enrolled
Paul Barr, MDStudy ChairWilmot Cancer Institute - University of Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
2018. "Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03379051.
~11 spots leftby Apr 2025
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