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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02164006
First received: June 12, 2014
Last updated: January 9, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Hodgkin's Lymphoma
Drug: TGR-1202 + brentuximab vedotin
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Brentuximab Vedotin in Combination With TGR-1202, a Novel PI3K Delta Inhibitor, in Patients With Hodgkins Lymphoma

Resource links provided by NLM:


Further study details as provided by TG Therapeutics, Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose acceptable for participants [ Time Frame: 21 days (1 cycle of therapy) ]
    To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities


Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Up to 1 year ]
    To assess the overall response rate (ORR) of TGR-1202 in combination with brentuximab vedotin in patients with Hodgkin's lymphoma


Other Outcome Measures:
  • Duration of Response [ Time Frame: Up to 1 year ]
    To evaluate the duration of response of TGR-1202 in combination with brentuximab vedotin


Estimated Enrollment: 14
Study Start Date: June 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TGR-1202 + brentuximab vedotin
TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin
Drug: TGR-1202 + brentuximab vedotin
TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin
Other Name: brentuximab vedotin: Adcetris

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Hodgkin's Lymphoma
  • Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT
  • 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. Patients who had prior Allogeneic hematologic stem cell transplant are excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02164006

Locations
United States, California
TG Therapeutics Investigational Trial Site
Duarte, California, United States, 91010
TG Therapeutics Investigational Trial Site
San Diego, California, United States, 92093
United States, Florida
TG Therapeutics Investigational Trial Site
Sarasota, Florida, United States, 34232
United States, Michigan
TG Therapeutics Investigational Trial Site
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
TG Therapeutics, Inc.
  More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02164006     History of Changes
Other Study ID Numbers: TGR-BV-107
Study First Received: June 12, 2014
Last Updated: January 9, 2017

Keywords provided by TG Therapeutics, Inc.:
Hodgkin's

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 22, 2017