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

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ClinicalTrials.gov Identifier: NCT02164006
Recruitment Status : Active, not recruiting
First Posted : June 16, 2014
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2014
Actual Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

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Arms and Interventions
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Arm Intervention/treatment
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


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164006


Locations
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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
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02164006     History of Changes
Other Study ID Numbers: TGR-BV-107
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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

Additional relevant MeSH terms:
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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