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Completed

NCT Number: NCT02535286

Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

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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 Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Richter Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TG Therapeutics Investigational Trial Site, New York, 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 diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
  • 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 14 days
  • Known hepatitis B virus, hepatitis C virus or HIV infection
  • Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)

Treatment and study plan

Umbralisib

Drug

A once daily oral agent

Other names: TGR-1202

Ublituximab

Biological

IV anti-CD20 monoclonal antibody

Other names: TG-1101

TG-1501

Biological

IV immunotherapy for cancer

Primary outcomes

  1. Determine Acceptable Adverse Events That Are Related to Treatment

    Time frame: 6 months 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

    The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Collaborators

  • Memorial Sloan Kettering Cancer Center

Registry information

Official study title

Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2015
Registry last updated
Oct 20, 2022

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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