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Clinical trial

A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 (Umbralisib) in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy

ID
Name
TGR-1202-201-CLL
Description
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).
Trial arms
Trial start
2016-04-21
Estimated PCD
2021-06-10
Trial end
2021-06-10
Status
Terminated
Phase
Early phase I
Treatment
Umbralisib
Umbralisib was administered as a tablet(s), orally once daily.
Arms:
Umbralisib
Other names:
TGR-1202
Size
51
Primary endpoint
Progression-free Survival
From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 51, 'type': 'ACTUAL'}}
Updated at
2024-07-02

1 organization

1 product

1 indication

Organization
TG Therapeutics
Product
Umbralisib
Indication
Chronic Lymphocytic Leukemia