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

TG Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Umbralisib; Drug: Acalabrutinib Oral Capsule; Drug: Ibrutinib; Drug: Ublituximab; Drug: Venetoclax

Study type: Interventional

Funder types: Industry

Identifiers

NCT04016805

UTX-TGR-208

Details and patient eligibility

About

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.

Full description

This is a Phase 2 open label, two treatment cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with CLL, who fail to achieve MRD negativity, after a minimum 6-month treatment with ibrutinib, alacabrutinib or venetoclax.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

ublituximab + umbralisib + ibrutinib

Experimental group

Description:

Participants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; ibrutinib oral tablet daily (1 Cycle = 28 days).

Treatment:

Drug: Ibrutinib

Drug: Umbralisib

Drug: Ublituximab

ublituximab + umbralisib + venetoclax

Experimental group

Description:

Participants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; venetoclax oral tablet daily (1 Cycle = 28 days).

Treatment:

Drug: Umbralisib

Drug: Ublituximab

Drug: Venetoclax

ublituximab + umbralisib + acalabrutinib

Experimental group

Description:

Participants were administered with ublituximab, 900 milligrams (mg), intravenous (IV) infusion once every cycle through cycle 6, then every three cycles upto 24 cycles; umbralisib, 800 mg, oral tablet, daily through Cycles 1-24; acalabrutinib oral capsule every 12 hours (1 Cycle = 28 days).

Treatment:

Drug: Umbralisib

Drug: Ublituximab

Drug: Acalabrutinib Oral Capsule