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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
TG Therapeutics, Inc.
Study ID
NCT04016805
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ublituximab — DRUG
    * recombinant chimeric anti-CD20 monoclonal antibody * administered as an IV infusion
  • Umbralisib — DRUG
    * Phosphoinositide-3-kinase (PI3K) delta inhibitor * Tablet form, to taken orally on a daily basis
  • Ibrutinib — DRUG
    * Bruton Tyrosine Kinase (BTK) inhibitor * Tablet form, to taken orally on a daily basis
  • Venetoclax — DRUG
    * BCL-2 inhibitor * Tablet form, to be taken orally
  • Acalabrutinib Oral Capsule — DRUG
    Kinase inhibitor, capsule form, to be taken orally

Study Details

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.

Key Dates

Start date
Aug 5, 2019
Status verified
Jul 2023
Primary completion
May 22, 2022
Completion
May 22, 2022

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ublituximab + umbralisib + ibrutinib
    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).
  • Experimental: ublituximab + umbralisib + venetoclax
    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).
  • Experimental: ublituximab + umbralisib + acalabrutinib
    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).

Primary Outcome Measure

Rate of Undetected Minimal Residual Disease (U-MRD) [ Time Frame: Up to approximately 23 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
TG Therapeutics Investigational Trial SiteBostonMassachusetts02114-
TG Therapeutics Investigational Trial SiteHackensackNew Jersey07601-
TG Therapeutics Investigational Trial SiteNew YorkNew York10065-

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