BridgeMD
New treatment option for CML (Chronic Myelogenous Leukemia)
Official title ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
ClinicalTrials.gov ID: NCT06787144
What this study is testing
What is ELVN-001?
ELVN-001 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cml (chronic myelogenous leukemia).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- QTc \>470 ms.
The study team makes the final eligibility decision.
Where it's taking place
- Akita, Akita, Japan
- Sapporo, Hokkaido, Japan
- Suita-shi, Osaka, Japan
- Shinjuku-ku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Akita, Akita, Japan; Sapporo, Hokkaido, Japan; Suita-shi, Osaka, Japan; Shinjuku-ku, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.