Chronic Lymphocytic Leukemia Clinical Trial
Phase I/II, FIH, Dose Escalation Trial of TL-895 and Expansion of TL-895 Monotherapy and Combination Therapy With Navtemadlin in Tx-NaÃ¯ve and R/R CLL/SLL Subjects
The purpose of this research study is to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies who failed at least 1 but no more than 3 prior therapies. Part 1 of this study is no longer enrolling participants.
Arms 1 & 2 of Part 2 of this study will test different doses of TL-895 in participants with R/R leukemia-cll/" >CLL or SLL who have failed at least 1 prior therapy. Arms 1 & 2 of Part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. If someone participates in arms 1 or 2 of Part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day. Arms 3 and 4 of Part 2 of this study will test the 150mg and 100mg BID dose of TL-895, respectively in treatment naÃ¯ve participants with CLL/SLL. Every participant in this study will receive TL-895.
Relapsed/refractory CLL or relapsed/refractory SLL (Arms 1, 2, 5, and 7)
Treatment naÃ¯ve CLL or SLL (Arm 3, 4, and 6)
ECOG performance status of â‰¤ 2
Adequate hematologic, hepatic, and renal functions
Prior treatment with any BTK or PI3K inhibitors
History of major organ transplant
Women who are pregnant or breastfeeding
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There are 15 Locations for this study
Columbus Ohio, 43210, United States
Germantown Tennessee, 38138, United States
Debrecen , 4002, Hungary
Eger , 3300, Hungary
Bologna , 40138, Italy
Skorzewo PoznaÅ„, 60-18, Poland
Krakow , 30-51, Poland
Lublin , 20-09, Poland
Opole , 46-02, Poland
ToruÅ„ , 87-10, Poland
Saint Petersburg , 19702, Russian Federation
Yaroslavl , 15002, Russian Federation
Kharkiv , 61000, Ukraine
Kyiv , 03110, Ukraine
Mykolaiv , 54058, Ukraine
London , , United Kingdom
Plymouth , , United Kingdom
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