ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
About this study
The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
- Condition
- CML (Chronic Myelogenous Leukemia), Chronic Phase CML
- Tested
- ELVN-001
- Sponsor
- Enliven Therapeutics
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: CML (Chronic Myelogenous Leukemia), Chronic Phase CML
- BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
- ECOG performance status of 0 to 2.
- The patient was born in Japan and both parents and grandparents are Japanese.
- Adequate hematologic, hepatic and renal function.
- Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.
Exclusion 3
- Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
- History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.
- QTc \>470 ms.
Where
4 sites, 4 recruiting
Akita University Hospital
Akita, Akita, Japan
Aiiku Hospital
Sapporo, Hokkaido, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
The University of Osaka Hospital
Suita-shi, Osaka, Japan
Contact
-
Yuzo Tomonaga
+81-3-6779-8000 ClinicalTrialInformation@cmic.co.jp
Potential match only. Final eligibility is determined by the study team.