Tenalisib has been evaluated as an investigational new drug in number of early clinical studies in patients with relapsed/refractory hematological malignancies and demonstrated acceptable safety and promising efficacy in these patients. Since these advanced relapsed/refractory patients have limited therapeutic options, it is reasonable to continue Tenalisib in responding patients post completion of their participation in previous clinical studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
BID Orally
University of California, Hellen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Division of Hematology, University of Colorado,
Denver, Colorado, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center
Treatment-related Adverse Events
To evaluate the safety and tolerability of Tenalisib as single agent. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 years
Time to Disease Progression
Number of patients with a time to progression. The time to progression is calculated from the day of enrollment in the study to disease progression or death due to any cause.
Time frame: 2 years
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Houston, Texas, United States
Ltd. M.Zodelava Hematology Centre
Tbilisi, Georgia
Medivest - Institute of Hematology and Transfusiology
Tbilisi, Georgia
Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.
Chorzów, Poland