TerminatedPhase 2

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

Stopped: (Strategic/Business Decision)

United States51 participantsStarted 2016-04-21

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Progression-free Survival

Timeframe: From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)

Trial details

NCT IDNCT02742090

SponsorTG Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-10

Results submitted2024-06-07

View on ClinicalTrials.gov More Chronic Lymphocytic Leukemia trials