Chronic Myeloid Leukemia study: ELVN-001
Official title A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
ClinicalTrials.gov ID: NCT05304377
What this study is testing
What is ELVN-001?
ELVN-001 is an investigational oral medicine being studied as a potential treatment for chronic myeloid 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
- This study aims to check if the drug is safe and to find the best dose to use in future studies.
- Who it's for
- People with chronic myeloid leukemia who have stopped responding to, or cannot tolerate, current standard treatments.
- What's involved
- Participants will receive the study drug and undergo regular medical tests to monitor their health and how their body handles the medication.
- Time commitment
- The source text does not specify the total duration or the number of required visits.
- 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 CML in chronic phase, with or without T315I mutation.
- US: The patient has failed or is intolerant to at least one prior second-generation tyrosine kinase inhibitor (TKI) or asciminib.
- ECOG performance status of 0 to 2.
- 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.
- QTc \>470 ms.
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
- The Bronx, New York, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Adelaide, Australia
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Toronto, Ontario, Canada
- Amiens, France
- Bordeaux, France
- Lille, France
- Limoges, France
- Lyon, France
- Aachen, Germany
- Berlin, Germany
- Frankfurt, Germany
- Homburg, Germany
- Jena, Germany
- Mannheim, Germany
+ 18 more site(s).
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, but 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?
This study is enrolling now at New York, New York, United States; The Bronx, New York, United States; Portland, Oregon, United States; Houston, Texas, United States; Adelaide, Australia; Ghent, Belgium and 32 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.