Clinical trial NCT03364231: Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia
Non Follicular Indolent Non-Hodgkin Lymphoma
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall Response Rate (ORR) as Assessed by Revised Response Criteria for Non- Hodgkin's Lymphoma (Lugano Classification) and Consensus-Based 6th International Workshop on Waldenstrom's Macroglobulinemia (IWWM)
timeFrame: Every 3 cycles (1 Cycle = 28 days) from Day 1 Cycle 1 up to approximately 4.2 years
measure: Duration of Response (DOR)
timeFrame: From the first demonstration of response to umbralisib till disease progression/death (up to approximately 4.2 years)
Secondary outcomes:
measure: Complete Response (CR) Rate
timeFrame: Every 3 cycles (1 Cycle = 28 days) from Day 1 Cycle 1 up to approximately 4.2 years
measure: Progression-Free Survival (PFS)
timeFrame: From date of randomization until the date of first documented progression (up to approximately 4.2 years)
measure: Time to Treatment Failure (TTF)
timeFrame: From first dose on Day 1 of Cycle 1 (28 days = 1 cycle) up to discontinuation of treatment (up to approximately 4.2 years)
measure: Number of Participants With at Least One Adverse Event (AE)
timeFrame: From first dose of study treatment up to end of study (up to approximately 4.2 years)
Other outcomes:
Locations:
city: Washington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: District of Columbia
city: Boston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Massachusetts
city: Hackensack
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: New York
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
Study officials:
affiliation: Lombardi Comprehensive Cancer Center
name: Bruce Cheson, MD
role: STUDY_CHAIR
References: