Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy

TG Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Umbralisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02742090

TGR-1202-201-CLL

Details and patient eligibility

About

The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
• Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
• Presence of measurable disease

Exclusion criteria

• Progression on prior BTK or PI3K delta inhibitor
• Prior treatment with TGR-1202
• Richter's transformation or CLL transformation to aggressive lymphoma

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Umbralisib

Experimental group

Description:

Participants received 800 milligrams (mg) of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months.

Treatment:

Drug: Umbralisib