Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
TG Therapeutics, Inc.
Study ID
NCT02006485
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ublituximab + TGR-1202 — DRUG
    Ublituximab IV infusion TGR-1202 oral daily dose
  • Ublituximab + TGR-1202 + ibrutinib — DRUG
    Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose
  • Ublituximab + TGR-1202 + bendamustine — DRUG
    Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion

Study Details

The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies

Key Dates

Start date
Dec 13, 2013
Status verified
Nov 2019
Primary completion
Oct 31, 2019
Completion
Oct 31, 2019

Study Design

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

Arms

  • Experimental: Ublituximab + TGR-1202
    Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose
  • Experimental: Ublituximab + TGR-1202 + ibrutinib
    Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose ibrutinib oral daily dose
  • Experimental: Ublituximab + TGR-1202 + bendamustine
    Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Bendamustine at a fixed IV infusion on Days 1 \& 2

Primary Outcome Measure

Maximum Tolerated Dose acceptable for participants [ Time Frame: 28 days (1 cycle of therapy) ]

Locations (6)

FacilityCityStateZIPSite coordinators
TG Therapeutics Investigational Trial SiteHuntsvilleAlabama35805-
TG Therapeutics Investigational Trial SiteJonesboroArkansas72401-
TG Therapeutics Investigational Trial SiteDuarteCalifornia91010-
TG Therapeutics Investigational Trial SiteAtlantaGeorgia30322-
TG Therapeutics Investigational Trial SiteOmahaNebraska68198-
MD Anderson Cancer CenterHoustonTexas77030-

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