TGR-1202 (Umbralisib) in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL)
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|ClinicalTrials.gov Identifier: NCT04163718|
Recruitment Status : Suspended (Increased SAE Occurrence)
First Posted : November 15, 2019
Last Update Posted : July 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Umbralisib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study to Assess the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Parameters of Umbralisib in Treatment Naïve Patients With Chronic Lymphocytic Leukemia (CLL)|
|Actual Study Start Date :||November 12, 2019|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2023|
|Experimental: Treatment with Umbralisib||
800 mg Umbralisib will be self-administered on an outpatient basis. Umbralisib will be taken orally once daily within 30 minutes of a meal until removal from study. This treatment will be administered in 4 week (28-day) cycles.
Other Name: TGR-1202
- Overall Response Rate (Complete Response and Partial Response) [ Time Frame: Up to 24 months ]Overall Response Rate (ORR) of Umbralisib Treatment will be determined according to the criteria of the International Workshop on Chronic Lymphocytic Leukemia. ORR is defined as the percent of participants who achieve Complete Response (CR) or Partial Response (PR).
- Progression Free Survival (PFS) [ Time Frame: Up to 24 months ]Progression Free Survival (PFS) is defined as the interval from registration to the earlier of the first documentation of definitive disease progression or death from any cause.
- Number of Participants with Serious Adverse Events [ Time Frame: Up to 24 months ]Number of participants with adverse events after receiving one dose of Umbralisib..
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163718
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Javier Pinilla, MD, PhD||Moffitt Cancer Center|