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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01767766
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : August 23, 2021
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : January 7, 2013
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: TGR-1202
TGR-1202 Daily Oral Dose
Drug: TGR-1202
TGR-1202 Daily Oral Dose

Primary Outcome Measures :
  1. Maximum Tolerated Dose acceptable for participants [ Time Frame: 28 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) in patients with hematologic malignancies treated with TGR-1202

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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;

Information from the National Library of Medicine

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 identifier (NCT number): NCT01767766

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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
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Study Chair: Howard Burris, MD, FACP SCRI Development Innovations, LLC
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: TG Therapeutics, Inc. Identifier: NCT01767766    
Other Study ID Numbers: TGR-1202-101 (HEMREF 31)
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, T-Cell, Peripheral
Hematologic Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, B-Cell
Lymphoma, T-Cell
Neoplasms by Site
Hematologic Diseases