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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

NCT04016805 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-07-24

Study results available
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Summary

Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.

Conditions

Interventions

DRUG

Ublituximab

* recombinant chimeric anti-CD20 monoclonal antibody * administered as an IV infusion

DRUG

Umbralisib

* Phosphoinositide-3-kinase (PI3K) delta inhibitor * Tablet form, to taken orally on a daily basis

DRUG

Ibrutinib

* Bruton Tyrosine Kinase (BTK) inhibitor * Tablet form, to taken orally on a daily basis

DRUG

Venetoclax

* BCL-2 inhibitor * Tablet form, to be taken orally

DRUG

Acalabrutinib Oral Capsule

Kinase inhibitor, capsule form, to be taken orally

Sponsors & Collaborators

  • TG Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-05
Primary Completion
2022-05-22
Completion
2022-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04016805 on ClinicalTrials.gov