Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies

This study is ongoing, but not recruiting participants.
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
First received: January 9, 2013
Last updated: February 1, 2016
Last verified: February 2016
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Peripheral T-Cell Lymphoma
Hodgkin's Lymphoma
Drug: TGR-1202
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies

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: 28 days (1 cycle of therapy) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202

Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TGR-1202
TGR-1202 Daily Oral Dose
Drug: TGR-1202
TGR-1202 Daily Oral Dose


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Refractory to or relapsed after at least 1 prior treatment regimen;
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2;
  • At least 18 years of age.

Exclusion Criteria:

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks);
  • Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months;
  • Known hepatitis B virus, hepatitis C virus or HIV infection;
  • Previous therapy with GS-1101 (CAL-101), IPI-145 or any drug that specifically inhibits the PI3K or mTOR pathway;
  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: NCT01767766

United States, Florida
TG Therapeutics Trial Site
Sarasota, Florida, United States, 34232
United States, New Jersey
TG Therapeutics Trial Site
Hackensack, New Jersey, United States, 07601
United States, New York
TG Therapeutics Trial Site
New York, New York, United States, 10019
United States, North Carolina
TG Therapeutics Trial Site
Durham, North Carolina, United States, 27710
United States, Ohio
TG Therapeutics Trial Site
Cincinnati, Ohio, United States, 45242
United States, Tennessee
TG Therapeutics Trial Site
Nashville, Tennessee, United States, 37203
United States, Wisconsin
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
TG Therapeutics, Inc.
SCRI Development Innovations, LLC
Study Chair: Howard Burris, MD, FACP SCRI Development Innovations, LLC
  More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01767766     History of Changes
Other Study ID Numbers: TGR-1202-101 (HEMREF 31) 
Study First Received: January 9, 2013
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 26, 2016