Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients

Last updated: October 1, 2019
Sponsor: TG Therapeutics, Inc.
Overall Status: Completed

Phase

1

Condition

Leukemia

Lymphoproliferative Disorders

Lymphoma

Treatment

N/A

Clinical Study ID

NCT02164006
TGR-BV-107
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with brentuximab vedotin in patients with hodgkin's lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of Hodgkin's Lymphoma

  • Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least twoprior multi-agent chemotherapy regimens in patients not candidates for ASCT

  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion

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. Patientswho had prior Allogeneic hematologic stem cell transplant are excluded

Study Design

Total Participants: 16
Study Start date:
June 11, 2014
Estimated Completion Date:
May 31, 2016

Connect with a study center

  • TG Therapeutics Investigational Trial Site

    Duarte, California 91010
    United States

    Site Not Available

  • TG Therapeutics Investigational Trial Site

    San Diego, California 92093
    United States

    Site Not Available

  • TG Therapeutics Investigational Trial Site

    Sarasota, Florida 34232
    United States

    Site Not Available

  • TG Therapeutics Investigational Trial Site

    Detroit, Michigan 48201
    United States

    Site Not Available

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