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

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ClinicalTrials.gov Identifier: NCT03364231
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Marginal Zone Lymphoma Waldenstrom Macroglobulinemia Drug: Umbralisib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Experimental: Umbralisib
Umbralisib oral daily dose
Drug: Umbralisib
Oral Daily Dose
Other Name: TGR-1202




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

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


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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
United States, Massachusetts
TG Therapeutics Investigational Trial Site Recruiting
Boston, Massachusetts, United States, 02215
United States, New Jersey
TG Therapeutics Investigational Trial Site Recruiting
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
Study Chair: Bruce Cheson, MD Lombardi Comprehensive Cancer Center

Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03364231     History of Changes
Other Study ID Numbers: TGR-1202-202
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: November 1, 2018
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