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โ† Trials
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ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants

RecruitingPhase 1Ages 18 Years - anyAllEnliven Therapeutics
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 โ‰ฅ 6 months prior to the first dose of ELVN-001. Exclusion Criteria: * 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.
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What it tests

  • ELVN-001
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Where

4 sites
Akita University Hospital
Akita, Japan
Aiiku Hospital
Sapporo, Japan
The University of Osaka Hospital
Suita-shi, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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