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

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.
 
ClinicalTrials.gov Identifier: NCT03364231
Recruitment Status : Active, not recruiting
First Posted : December 6, 2017
Last Update Posted : September 11, 2020
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 that has come back or that has not responded to standard treatment.

Condition or disease Intervention/treatment Phase
Waldenstrom Macroglobulinemia Drug: Umbralisib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
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 : November 1, 2020
Estimated Study Completion Date : February 1, 2021


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 ]


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

Inclusion Criteria:

  • Confirmed diagnosis of 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


Locations
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United States, District of Columbia
TG Therapeutics Investigational Trial Site
Washington, District of Columbia, United States, 20007
United States, Massachusetts
TG Therapeutics Investigational Trial Site
Boston, Massachusetts, United States, 02215
United States, New Jersey
TG Therapeutics Investigational Trial Site
Hackensack, New Jersey, United States, 07601
United States, New York
TG Therapeutics Investigational Trial Site
New York, New York, United States, 10065
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
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Study Chair: Bruce Cheson, MD Lombardi Comprehensive Cancer Center
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03364231    
Other Study ID Numbers: TGR-1202-202
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Lymphoma
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