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NCT05304377RecruitingPhase 1

A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia

Source: ClinicalTrials.gov · Last updated 1 Apr 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
250 (estimated)
First submitted
15 Mar 2022
Start date
22 May 2022
Primary completion date
Dec 2027
Lead sponsor
Enliven Therapeutics
NCT number
NCT05304377
EU CT number
2023-503335-18-00
EudraCT number
2022-000052-11

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 250
  • From 22 May 2022 to the primary completion date, Dec 2027
  • 42 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.

Other illness

  • 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.

Lab values

  • QTc \>470 ms.

Who the study is looking for

  • 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. Rest of World: The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML (country-specific criteria may vary).
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
University Health Network UHN Princess Margaret Cancer Centre
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TorontoCanadaRecruiting
Universitaetsklinikum Aachen AöR
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AachenGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Universitaet Des Saarlandes
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HomburgGermanyRecruiting
Universitaetsklinikum Jena KöR
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JenaGermanyRecruiting
Universitat Heidelberg
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MannheimGermanyRecruiting
Rostock University Medical Center
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RostockGermanyRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Centre Hospitalier Et Universitaire de Limoges
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LimogesFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,
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GlasgowUnited KingdomRecruiting
Hammersmith Hospital, Imperial College Healthcare NHS Trust
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LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust
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ManchesterUnited KingdomRecruiting
Semmelweis University
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Budapest VIIIHungaryRecruiting
University of Pecs
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PécsHungaryRecruiting
Hadassah medical Center
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JerusalemIsraelRecruiting
The Galilee Medical Center
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NahariyaIsraelRecruiting
Rabin Medical Center
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Petah TikvaIsraelRecruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyRecruiting
Keimyung University Dongsan Hospital
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DaeguSouth KoreaWithdrawn
Uijeongbu Eulji Medical Center
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Gyeonggi-doSouth KoreaRecruiting
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaWithdrawn
Chonbuk National University Hospital
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JeonjuSouth KoreaWithdrawn
Samsung Medical Center
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SeoulSouth KoreaWithdrawn
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsRecruiting
Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ
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Nowy SaczPolandRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandRecruiting
Instytut Hematologii I Transfuzjologii
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WarsawPolandRecruiting
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Oregon Health & Science University-Knight Cardiovascular Institute
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PortlandUnited StatesRecruiting
Montefiore Medical Center
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The BronxUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.