What side effects are associated with this type of intervention?

Common treatments for chronic myeloid leukemia (CML), especially those targeting the T315I mutation, include tyrosine kinase inhibitors (TKIs) such as imatinib, dasatinib, and newer agents like ponatinib. Known side effects of these treatments can include hematologic toxicities (e.g., anemia, thrombocytopenia, neutropenia), gastrointestinal issues (e.g., nausea, diarrhea), fluid retention, muscle cramps, and fatigue. Additionally, targeted therapies may cause skin reactions, including rashes and alopecia, as well as cardiovascular events in some cases. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for chronic myeloid leukemia (CML), particularly targeting patients with the T315I mutation. Ponatinib (Iclusig) is a notable example, specifically designed to inhibit the BCR-ABL protein with the T315I mutation. Other TKIs like imatinib (Gleevec), dasatinib (Sprycel), and nilotinib (Tasigna) are also approved for CML but may not be effective against the T315I mutation. For broader leukemia treatment, drugs such as decitabine and azacitidine are used, especially in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

What other types of research exist?

Promising alternatives to ELVN-001 for treating chronic myeloid leukemia with the T315I mutation include ponatinib, a third-generation tyrosine kinase inhibitor (TKI) specifically designed to target the T315I mutation. Additionally, asciminib, a STAMP inhibitor, has shown efficacy in patients with CML, including those with the T315I mutation. Both therapies have demonstrated significant clinical benefits and are considered viable options for patients in 2024.

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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called ELVN-001 for safety and effectiveness in patients with chronic myeloid leukemia who have not had success with other treatments. The drug aims to reduce cancer markers in the blood to better control the disease.

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.

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).

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any cancer or CML medication in the last 7 days or 5 half-lives, whichever is longer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Phase 1a and 1b: area under the curve

Phase 1a and 1b: maximum concentration

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for leukemia, particularly chronic myeloid leukemia (CML) with specific mutations like T315I, include tyrosine kinase inhibitors (TKIs) and targeted therapies. TKIs, such as imatinib, dasatinib, and newer agents like ponatinib, work by inhibiting the BCR-ABL tyrosine kinase, which is produced by the Philadelphia chromosome abnormality in CML. This inhibition prevents the proliferation of leukemic cells. For mutations like T315I, which confer resistance to many TKIs, newer agents like ponatinib or investigational drugs like ELVN-001 are designed to overcome this resistance by binding to the kinase domain in a way that is not affected by the mutation. These targeted therapies are crucial for leukemia patients as they offer more effective treatment options with potentially fewer side effects compared to traditional chemotherapy, improving outcomes and quality of life.

Role of epigenetic in leukemia: From mechanism to therapy.FLT3 inhibitors in the treatment of acute myeloid leukemia: current status and future perspectives.Molecular targeting in acute myeloid leukemia.