Clinical trial

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

Name

TGR-1202-202

Description

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.

Trial arms

Trial start

2017-11-30

Estimated PCD

2022-02-15

Trial end

2022-02-15

Status

Completed

Phase

Early phase I

Treatment

Umbralisib

Oral Daily Dose

Arms:

Marginal Zone Lymphoma (MZL): Umbralisib, Waldenstrom's Macroglobulinemia (WM): Umbralisib

Other names:

TGR-1202

Size

Primary endpoint

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)

Every 3 cycles (1 Cycle = 28 days) from Day 1 Cycle 1 up to approximately 4.2 years

Duration of Response (DOR)

From the first demonstration of response to umbralisib till disease progression/death (up to approximately 4.2 years)

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 21, 'type': 'ACTUAL'}}

Updated at

2023-06-23

1 organization

Organization

TG Therapeutics