Treatment of Chronic Myeloid Leukemia with ELVN-001 in Japanese Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and tolerability of ELVN-001, a new treatment for chronic myeloid leukemia (CML), in Japanese patients who have not responded to or cannot tolerate at least two prior tyrosine kinase inhibitors (TKIs). It is a first-in-human, dose escalation study aimed at determining the recommended dose for further evaluation. The study will also assess the pharmacokinetics and anti-CML activity of ELVN-001, particularly in patients with or without the T315I mutation. The findings will inform future development of this treatment for adults with CML.

Why it matters

Who can join: the full rules

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 ≥ 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.

Where it's running

• Akita University Hospital
  Akita, Akita, Japan Recruiting
• Aiiku Hospital
  Sapporo, Hokkaido, Japan Recruiting
• The University of Osaka Hospital
  Suita-shi, Osaka, Japan Recruiting
• Tokyo Medical University Hospital
  Shinjuku-ku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Yuzo Tomonaga
• Email: ClinicalTrialInformation@cmic.co.jp
• Phone: +81-3-6779-8000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Vididencel in CML-CP Patients with MRD

  This study tests whether the cell therapy vididencel can be given safely to adults with chronic myeloid leukemia in chronic phase who still have measurable residual disease despite long-term TKI therapy.

  Recruiting Phase 1 Mendus · Bergen · NCT07651878

• Post-transplant cyclophosphamide strategies to prevent graft-versus-host disease after mismatched unrelated donor stem cell transplant

  This platform tests whether adding different drug combinations with post-transplant cyclophosphamide prevents graft‑versus‑host disease better than the standard regimen for adults getting mismatched unrelated donor peripheral blood stem cell transplants for blood cancers.

  Recruiting at 13 sites Phase 2 Center for International Blood and Marrow Transplant Research · Birmingham, Alabama and 12 other locations · NCT06859424

• Treatment of Chronic Myeloid Leukemia with Olverembatinib

  This study is testing if a new drug called olverembatinib can help people with chronic myeloid leukemia feel better compared to an existing treatment, and it looks at two groups of patients based on a specific genetic mutation.

  Recruiting at 135 sites Phase 3 Ascentage Pharma Group Inc. · Birmingham, Alabama and 162 other locations · NCT06423911

• Potential of asciminib in early chronic‑phase CML

  This trial will see if asciminib alone, or asciminib plus nilotinib, helps adults newly diagnosed with chronic‑phase, BCR‑ABL–positive CML reach deep molecular responses and remain off treatment.

  Recruiting at 11 sites Phase 2 Gruppo Italiano Malattie EMatologiche dell'Adulto · Barcelona and 10 other locations · NCT06409936

• Efficacy and safety of Radotinib for chronic myeloid leukemia patients who failed previous treatments

  This study is testing if Radotinib can help people with chronic myeloid leukemia who haven't had success with other treatments feel better and stay safe while using it.

  Recruiting at 16 sites Phase 3 Il-Yang Pharm. Co., Ltd. · Barnaul and 17 other locations · NCT03459534

• Access and distribution of unlicensed cryopreserved cord blood units

  This study is testing how well unlicensed frozen cord blood units work for helping both kids and adults with blood cancers recover after a transplant.

  Recruiting at 113 sites Center for International Blood and Marrow Transplant Research · Birmingham, Alabama and 141 other locations · NCT01351545

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.