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Completed

NCT Number: NCT02006485

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TG Therapeutics Investigational Trial Site, Huntsville, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: Imbruvica

Ublituximab + TGR-1202 + bendamustine

Drug

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

Other names: Treanda

Primary outcomes

  1. Maximum Tolerated Dose acceptable for participants

    Time frame: 28 days (1 cycle of therapy)

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

Secondary outcomes

  1. Overall Response Rate

    Time frame: Up to 1 year

    To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with TGR-1202

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination With TGR-1202, a Novel PI3k Delta Inhibitor; and Ibrutinib or Bendamustine, in Patients With B-cell Malignancies.

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2013
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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