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CompletedNCT02164006Updated Oct 2, 2019

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

A Phase 1 interventional study of TGR-1202 + brentuximab vedotin in Hodgkin's Lymphoma, sponsored by TG Therapeutics, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-02.

Sponsored by TG Therapeutics, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Hodgkin's Lymphoma

Keywords

  • Hodgkin's
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 16 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

TG Therapeutics, Inc. is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • 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

Interventions

  • DrugTGR-1202 + brentuximab vedotin

    TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin

    Also known as: brentuximab vedotin: Adcetris

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose acceptable for participants

    To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

    Time frame: 21 days (1 cycle of therapy)

Secondary outcomes

  1. Overall Response Rate

    To assess the overall response rate (ORR) of TGR-1202 in combination with brentuximab vedotin in patients with Hodgkin's lymphoma

    Time frame: Up to 1 year

Other outcomes

  1. Duration of Response

    To evaluate the duration of response of TGR-1202 in combination with brentuximab vedotin

    Time frame: Up to 1 year

07

Study locations

4 sites
  • TG Therapeutics Investigational Trial Site
    Duarte, California 91010, United States
  • TG Therapeutics Investigational Trial Site
    San Diego, California 92093, United States
  • TG Therapeutics Investigational Trial Site
    Sarasota, Florida 34232, United States
  • TG Therapeutics Investigational Trial Site
    Detroit, Michigan 48201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02164006
Lead sponsor
TG Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jun 16, 2014
Start date
Jun 11, 2014
Primary completion
May 2016
Completion
May 2016
Last update
Oct 2, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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