Clinical trial

A Phase 2 Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

Name

UTX-TGR-208

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.

Trial arms

Trial start

2019-08-05

Estimated PCD

2022-05-22

Trial end

2022-05-22

Status

Terminated

Phase

Early phase I

Treatment

Ublituximab

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

Arms:

ublituximab + umbralisib + acalabrutinib, ublituximab + umbralisib + ibrutinib, ublituximab + umbralisib + venetoclax

Other names:

TG-1101

Umbralisib

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

Arms:

ublituximab + umbralisib + acalabrutinib, ublituximab + umbralisib + ibrutinib, ublituximab + umbralisib + venetoclax

Other names:

TGR-1202

Ibrutinib

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

Arms:

ublituximab + umbralisib + ibrutinib

Other names:

Imbruvica

Venetoclax

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

Arms:

ublituximab + umbralisib + venetoclax

Other names:

Venclexta

Acalabrutinib Oral Capsule

Kinase inhibitor, capsule form, to be taken orally

Arms:

ublituximab + umbralisib + acalabrutinib

Other names:

Calquence

Size

Primary endpoint

Rate of Undetected Minimal Residual Disease (U-MRD)

Up to approximately 23 months

Eligibility criteria

Inclusion Criteria: * Participants with Chronic Lymphocytic Leukemia (CLL) who have been on treatment for at least 6 months * Minimal Residual Disease positive at screening * Adequate organ system function as specified in the protocol * Ability to follow protocol procedures. Exclusion Criteria: * Participants receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1. * Participants with a known histological transformation * Active Hepatitis B or Hepatitis C.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 41, 'type': 'ACTUAL'}}

Updated at

2023-07-24

1 organization

5 products

1 indication

Product

Ublituximab

Indication

Chronic Lymphocytic Leukemia

Product

Product

Product

Product

Organization