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

NCT02006485 | Completed Phase 1 DMC

• 1 other identifier: UTX-TGR-103
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Chronic Lymphocytic Leukemia; Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose acceptable for participants

  To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

  28 days (1 cycle of therapy)

Secondary Outcomes (1)

• Overall Response Rate

  Up to 1 year

Study Arms (3)

Ublituximab + TGR-1202

EXPERIMENTAL

Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose

Drug: Ublituximab + TGR-1202

Ublituximab + TGR-1202 + ibrutinib

EXPERIMENTAL

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

Drug: Ublituximab + TGR-1202 + ibrutinib

Ublituximab + TGR-1202 + bendamustine

EXPERIMENTAL

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

Drug: Ublituximab + TGR-1202 + bendamustine

Interventions

Ublituximab + TGR-1202 DRUG

Ublituximab IV infusion TGR-1202 oral daily dose

Ublituximab + TGR-1202

Ublituximab + TGR-1202 + ibrutinib DRUG

Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose

Also known as: Imbruvica

Ublituximab + TGR-1202 + ibrutinib

Ublituximab + TGR-1202 + bendamustine DRUG

Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion

Also known as: Treanda

Ublituximab + TGR-1202 + bendamustine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair
• Refractory to or relapsed after at least 1 prior treatment regimen
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

You may not qualify if:

• Any major surgery, chemotherapy or immunotherapy within the last 21 days
• Known hepatitis B virus, hepatitis C virus or HIV infection
• Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months
• Primary central nervous system lymphoma or known intracranial involvement

Sponsors & Collaborators

• TG Therapeutics, Inc.: lead

Study Sites (6)

TG Therapeutics Investigational Trial Site

Huntsville, Alabama, 35805, United States

Location

TG Therapeutics Investigational Trial Site

Jonesboro, Arkansas, 72401, United States

Location

TG Therapeutics Investigational Trial Site

Duarte, California, 91010, United States

Location

TG Therapeutics Investigational Trial Site

Atlanta, Georgia, 30322, United States

Location

TG Therapeutics Investigational Trial Site

Omaha, Nebraska, 68198, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Lunning M, Vose J, Nastoupil L, Fowler N, Burger JA, Wierda WG, Schreeder MT, Siddiqi T, Flowers CR, Cohen JB, Sportelli P, Miskin HP, Weiss MS, O'Brien S. Ublituximab and umbralisib in relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. Blood. 2019 Nov 21;134(21):1811-1820. doi: 10.1182/blood.2019002118.

  PMID: 31558467 DERIVED

• Nastoupil LJ, Lunning MA, Vose JM, Schreeder MT, Siddiqi T, Flowers CR, Cohen JB, Burger JA, Wierda WG, O'Brien S, Sportelli P, Miskin HP, Purdom MA, Weiss MS, Fowler NH. Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukaemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial. Lancet Haematol. 2019 Feb;6(2):e100-e109. doi: 10.1016/S2352-3026(18)30216-3.

  PMID: 30709431 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin

Interventions

ublituximab; umbralisib; ibrutinib; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nathan Fowler, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

• Susan O'Brien, MD

  University of California Irvine Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Study Start: December 13, 2013
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-11

Locations

US (6)