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ELVN-001 for Chronic Myelogenous Leukemia (CML Trial)

Phase 1

Recruiting

Research Sponsored by Enliven Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0 to 2

CML patients who have failed or are intolerant to available active therapies for their CML

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

CML Trial Summary

This trial is testing a new drug for people with leukemia who have mutations that make other treatments ineffective. The goal is to find a safe dose of the new drug to use in future studies.

Who is the study for?

This trial is for adults with chronic myeloid leukemia who have not responded well to, or cannot tolerate, current treatments. Participants should be relatively active (ECOG status 0-2) and have good blood, liver, and kidney function. Those with a recent history of cancer treatment or abnormal heart rhythm (QTc >470 ms) are excluded.Check my eligibility

What is being tested?

The study is testing ELVN-001's safety and the right dose for people with chronic myeloid leukemia, including those with T315I mutations who haven't had success with tyrosine kinase inhibitors (TKIs).See study design

What are the potential side effects?

While specific side effects of ELVN-001 aren't listed here, common ones in such trials include fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies, liver issues and potential allergic reactions.

CML Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself and am up and about more than 50% of my waking hours.

Select...

I have CML and cannot tolerate or haven't responded to current treatments.

CML Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1a: Incidence of adverse events (AEs)

Phase 1a: Incidence of clinically significant ECG abnormalities

Phase 1a: Incidence of clinically significant laboratory abnormalities

+4 more

Secondary outcome measures

Phase 1a and 1b: Molecular response (MR)

Phase 1a and 1b: area under the curve

Phase 1a and 1b: maximum concentration

+4 more

CML Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 1b expansion arm in T315I mutated CMLExperimental Treatment1 Intervention

ELVN-001 administered at the recommended dose for CML with T315I mutation

Group II: Phase 1b Dose Expansion at recommended dose level 2Experimental Treatment1 Intervention

ELVN-001 administered at a different recommended dose in CML without T315I mutations

Group III: Phase 1b Dose Expansion at recommended dose level 1Experimental Treatment1 Intervention

ELVN-001 administered at the recommended dose in CML without T315I mutations

Group IV: Phase 1a Dose EscalationExperimental Treatment1 Intervention

ELVN-001 administered in 3+3 dose escalation

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Enliven TherapeuticsLead Sponsor

2 Previous Clinical Trials

433 Total Patients Enrolled

Media Library

ELVN-001 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05304377 — Phase 1

Leukemia Research Study Groups: Phase 1b expansion arm in T315I mutated CML, Phase 1a Dose Escalation, Phase 1b Dose Expansion at recommended dose level 1, Phase 1b Dose Expansion at recommended dose level 2

Leukemia Clinical Trial 2023: ELVN-001 Highlights & Side Effects. Trial Name: NCT05304377 — Phase 1

ELVN-001 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05304377 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant capacity of this clinical trial?

"In order to conduct this research, 120 eligible participants must be recruited. Enliven Therapeutics is running the trial in a number of locations including Memorial Sloan Kettering Cancer Center (New york) and The University of Texas MD Anderson Cancer Center (Houston)."

Answered by AI

Is recruitment for this research endeavor still open?

"According to the records on clinicaltrials.gov, this trial is actively searching for participants, having been first posted in May 2022 and updated most recently in November of that year."

Answered by AI

What aims does this investigation seek to achieve?

"Per Enliven Therapeutics, the main outcome to be gauged over a 28 day period is Phase 1a: Occurrences of dose limiting toxicities. Additionally, they aim to observe secondary outcomes such as Phase 1a and 1b: minimum concentration (PK parameter based on drug concentration at steady state), Phase 1a and 1b: time of maximum concentration (PK parameter determining peak blood concentrations), and Phase 1a and 1b: area under the curve (PK parameter measuring drug levels in blood)."

Answered by AI

What risks and hazards might come with usage of ELVN-001?

"Due to the limited clinical data available, ELVN-001 has been rated a 1 on our safety scale of one to three. This is reflective of this being a Phase 1 trial and thus having minimal evidence supporting its efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05304377.