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

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ClinicalTrials.gov Identifier: NCT01767766

Recruitment Status : Completed

First Posted : January 14, 2013

Last Update Posted : September 4, 2019

Sponsor:

Collaborator:

SCRI Development Innovations, LLC

Information provided by (Responsible Party):

TG Therapeutics, Inc.

Study Description

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated 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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Chronic Lymphocytic Leukemia Hodgkin Lymphoma Peripheral T-cell Lymphoma

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

Information from the National Library of Medicine

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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:

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

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 ClinicalTrials.gov identifier (NCT number): NCT01767766

Locations

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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

Investigators

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Study Chair:	Howard Burris, MD, FACP	SCRI Development Innovations, LLC

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Burris HA 3rd, Flinn IW, Patel MR, Fenske TS, Deng C, Brander DM, Gutierrez M, Essell JH, Kuhn JG, Miskin HP, Sportelli P, Weiss MS, Vakkalanka S, Savona MR, O'Connor OA. Umbralisib, a novel PI3Kδ and casein kinase-1ε inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study. Lancet Oncol. 2018 Apr;19(4):486-496. doi: 10.1016/S1470-2045(18)30082-2. Epub 2018 Feb 20.

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Responsible Party:	TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT01767766
Other Study ID Numbers:	TGR-1202-101 (HEMREF 31)
First Posted:	January 14, 2013 Key Record Dates
Last Update Posted:	September 4, 2019
Last Verified:	September 2019

Additional relevant MeSH terms:

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Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Hematologic Neoplasms Lymphoma, T-Cell, Peripheral Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders	Immune System Diseases Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia Leukemia, B-Cell Lymphoma, T-Cell Neoplasms by Site Hematologic Diseases

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