NCT04016805 is a Phase 2 clinical trial of Ublituximab in Chronic Lymphocytic Leukemia, sponsored by TG Therapeutics, Inc..

Who is sponsoring NCT04016805?

NCT04016805 is sponsored by TG Therapeutics, Inc..

What drugs are being tested in NCT04016805?

Interventions in NCT04016805: Ublituximab, Umbralisib, Ibrutinib, Venetoclax, Acalabrutinib Oral Capsule.

What condition does NCT04016805 study?

NCT04016805 studies Chronic Lymphocytic Leukemia.

Is NCT04016805 still recruiting?

NCT04016805 is currently terminated. Last updated 24 July 2023.

Are results published for NCT04016805?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-07-24 · How we verify

NCT04016805

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Results posted Last updated 24 July 2023

What this trial tests

Phase 2 trial testing Ublituximab in Chronic Lymphocytic Leukemia in 41 participants. Terminated before completion.

Timeline

5 August 2019

Primary endpoint
22 May 2022

22 May 2022

Quick facts

Lead sponsor	TG Therapeutics, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	5 August 2019
Primary completion	22 May 2022
Estimated completion	22 May 2022
Sites	3 locations across United States

Drugs / interventions tested

Ublituximab
Umbralisib — full drug profile →
Ibrutinib (ibrutinib) — full drug profile →
Venetoclax (venetoclax) — full drug profile →
Acalabrutinib Oral Capsule

Conditions studied

Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →

Sponsor

TG Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Fc-Engineered Antibodies with Enhanced Fc-Effector Function for the Treatment of B-Cell Malignancies.
van der Horst HJ, Nijhof IS, Mutis T, Chamuleau MED. · · 2020 · cited 56× · PMID 33086644 · DOI 10.3390/cancers12103041
Managing toxicities of phosphatidylinositol-3-kinase (PI3K) inhibitors.
Hanlon A, Brander DM. · · 2020 · cited 49× · PMID 33275709 · DOI 10.1182/hematology.2020000119
Overcoming resistance to targeted therapies in chronic lymphocytic leukemia.
Skånland SS, Mato AR. · · 2021 · cited 42× · PMID 33570649 · DOI 10.1182/bloodadvances.2020003423
PI3K Inhibitors for the Treatment of Chronic Lymphocytic Leukemia: Current Status and Future Perspectives.
Hus I, Puła B, Robak T. · · 2022 · cited 34× · PMID 35326722 · DOI 10.3390/cancers14061571
PI3K/Akt Pathway: The Indestructible Role of a Vintage Target as a Support to the Most Recent Immunotherapeutic Approaches.
Caforio M, de Billy E, De Angelis B, Iacovelli S, et al · · 2021 · cited 29× · PMID 34439194 · DOI 10.3390/cancers13164040
Immunometabolism in cancer: basic mechanisms and new targeting strategy.
Su R, Shao Y, Huang M, Liu D, et al · · 2024 · cited 28× · PMID 38755125 · DOI 10.1038/s41420-024-02006-2
Integrated safety analysis of umbralisib, a dual PI3Kδ/CK1ε inhibitor, in relapsed/refractory lymphoid malignancies.
Davids MS, O'Connor OA, Jurczak W, Samaniego F, et al · · 2021 · cited 16× · PMID 34547767 · DOI 10.1182/bloodadvances.2021005132
Adding Umbralisib and Ublituximab (U2) to Ibrutinib in Patients with CLL: A Phase II Study of an MRD-Driven Approach.
Roeker LE, Feldman TA, Soumerai JD, Falco V, et al · · 2022 · cited 12× · PMID 35852793 · DOI 10.1158/1078-0432.ccr-22-0964

Verify or expand the search:

Other trials of Ublituximab

Trials testing the same drug.

NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis · Phase 2, PHASE3 · not yet recruiting
NCT06864936 — Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis · NA · not yet recruiting
NCT07503873 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection · Phase 2 · not yet recruiting
NCT07225361 — Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis · Phase 4 · recruiting
NCT06629428 — Effects of Ublituximab on Motor Functions in Multiple Sclerosis · EARLY_PHASE1 · recruiting

Other recruiting trials for Chronic Lymphocytic Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06863402 — Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype · Phase 2 · recruiting
NCT07218510 — Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Smal · Phase 2 · recruiting
NCT07288515 — Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus · recruiting
NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL · Phase 2 · recruiting

Other TG Therapeutics, Inc. trials

Trials by the same sponsor.

NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis · Phase 2, PHASE3 · not yet recruiting
NCT07503873 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection · Phase 2 · not yet recruiting
NCT07211633 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ub · Phase 3 · recruiting
NCT06680037 — A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders · Phase 1 · recruiting
NCT06433752 — A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Mult · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04016805 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by TG Therapeutics, Inc.
Last refreshed: 24 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04016805.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing