This trial is active, not recruiting.

Condition hodgkin's lymphoma
Treatment tgr-1202 + brentuximab vedotin
Phase phase 1
Targets PI3K, CD30
Sponsor TG Therapeutics, Inc.
Start date June 2014
End date July 2016
Trial size 14 participants
Trial identifier NCT02164006, TGR-BV-107


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin
tgr-1202 + brentuximab vedotin brentuximab vedotin: Adcetris
TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin

Primary Outcomes

Maximum Tolerated Dose acceptable for participants
time frame: 21 days (1 cycle of therapy)

Secondary Outcomes

Overall Response Rate
time frame: Up to 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by TG Therapeutics, Inc..
Location data was received from the National Cancer Institute and was last updated in March 2016.