Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

Part of paid clinical trials in Chicago, Illinois.

Sponsor
TG Therapeutics, Inc.
Study ID
NCT03379051
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    BCL-2 Inhibitor
  • Umbralisib — DRUG
    PI3K-Delta Inhibitor
  • Ublituximab — BIOLOGICAL
    Glycoengineered Anti-CD20 mAb
  • Lenalidomide — DRUG
    Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties

Study Details

Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL

Key Dates

Start date
Mar 27, 2018
Status verified
Aug 2022
Primary completion
May 26, 2022
Completion
Jun 16, 2022

Study Design

Enrollment
78 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ublituximab + Umbralisib + Venetoclax
    Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
  • Experimental: Ublituximab + Umbralisib + Lenalidomide
    Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days

Primary Outcome Measure

Determine Acceptable Adverse Events That Are Related to Treatment [ Time Frame: 12 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
TG Therapeutics Investigational Trial SiteChicagoIllinois60611-
TG Therapeutics Investigational Trial SiteRochesterNew York14642-
TG Therapeutics Investigational Trial SiteClevelandOhio44195-

Find similar trials in Chicago, IL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
TG Therapeutics Investigational Trial Site· Chicago, ILTG Therapeutics Investigational Trial Site· Rochester, NYTG Therapeutics Investigational Trial Site· Cleveland, OH

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