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

TG Therapeutics

Status and phase: Completed; Phase 2

Conditions: Waldenstrom Macroglobulinemia; Non Follicular Indolent Non-Hodgkin Lymphoma; Marginal Zone Lymphoma

Treatments: Drug: Umbralisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03364231

TGR-1202-202

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Marginal Zone Lymphoma (MZL): Umbralisib

Experimental group

Description:

Participants with non-follicular indolent non-Hodgkin's lymphoma (iNHL) with MZL as the histology type received umbralisib, 800 milligrams (mg), orally, once daily (QD), until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.

Treatment:

Drug: Umbralisib

Waldenstrom's Macroglobulinemia (WM): Umbralisib

Experimental group

Description:

Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.

Treatment:

Drug: Umbralisib