RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-05-22
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05304377

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.
  2. * The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML.
  3. * ECOG performance status of 0 to 2.
  4. * Adequate hematologic, hepatic and renal function.
  5. * Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.
  1. * Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
  2. * 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.
  3. * QTc \>470 ms.

Contacts and Locations

Study Contact

Study Contact
CONTACT
707-799-3272
ELVN-001-101@enliventherapeutics.com

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Oregon Health & Science University-Knight Cardiovascular Institute
Portland, Oregon, 97239
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Enliven Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-22
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-05-22
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • CML
  • Tyrosine kinase inhibitor
  • T315I
  • T315I mutant
  • BCR-ABL
  • ENABLE
  • active site inhibitor of BCR-ABL

Additional Relevant MeSH Terms

  • Chronic Myeloid Leukemia
  • Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
  • Cml