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Study to Assess the Efficacy and Safety of Umbralisib in Patients With Non-Follicular Indolent Non-Hodgkin's Lymphoma

This study is currently recruiting participants.
Verified November 2017 by TG Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03364231
First Posted: December 6, 2017
Last Update Posted: December 6, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
TG Therapeutics, Inc.
  Purpose
This research study will evaluate the safety and efficacy of a study drug called Umbralisib (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia and Marginal Zone Lymphoma that has come back or that has not responded to standard treatment.

Condition Intervention Phase
Marginal Zone Lymphoma Waldenstrom Macroglobulinemia Drug: Umbralisib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Assess the Efficacy and Safety of TGR-1202 (Umbralisib) Monotherapy in Patients With Non-Follicular Indolent Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by TG Therapeutics, Inc.:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Every 12 weeks, up to 2 years ]

Secondary Outcome Measures:
  • Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression, assessed up through 2 years ]

Estimated Enrollment: 40
Actual Study Start Date: November 30, 2017
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Umbralisib
Umbralisib oral daily dose
Drug: Umbralisib
Oral Daily Dose
Other Name: TGR-1202

  Eligibility

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Marginal Zone Lymphoma or Waldenstroms Macroglobulinemia
  • Relapsed or refractory after at least one prior treatment regimen
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
  • Prior autologous stem cell transplant within 6 months of study entry
  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): NCT03364231


Contacts
Contact: TG Therapeutics Clinical Support Team 212-554-4279 clinicalsupport@tgtxinc.com

Locations
United States, District of Columbia
TG Therapeutics Investigational Trial Site Recruiting
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
Study Chair: Bruce Cheson, MD Lombardi Comprehensive Cancer Center
  More Information

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03364231     History of Changes
Other Study ID Numbers: TGR-1202-202
First Submitted: November 30, 2017
First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders