ELVN-001 for Chronic Myelogenous Leukemia
(CML Trial)
Recruiting in Palo Alto (17 mi)
+28 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Enliven Therapeutics
Must not be taking: Anti-cancer, Anti-CML
Disqualifiers: Pancreatitis, QTc >470 ms, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you stop taking any anti-cancer or anti-CML medications at least 7 days before starting the study drug, or longer if the medication stays in your body for a while (5 half-lives).
What data supports the effectiveness of the drug ELVN-001 for chronic myelogenous leukemia?
The research highlights the success of tyrosine kinase inhibitors (TKIs) like imatinib, nilotinib, and dasatinib in improving survival rates for chronic myelogenous leukemia (CML). These drugs target the BCR-ABL protein, which is involved in CML, suggesting that similar mechanisms might support the effectiveness of ELVN-001 if it functions in a comparable way.
12345Eligibility Criteria
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.Inclusion Criteria
I can care for myself and am up and about more than 50% of my waking hours.
I have CML and cannot tolerate or haven't responded to current treatments.
My blood, liver, and kidney functions are all within normal ranges.
Exclusion Criteria
I haven't taken any cancer or CML medication in the last 7 days or 5 half-lives, whichever is longer.
QTc >470 ms
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
ELVN-001 administered in 3+3 dose escalation to determine the recommended dose for expansion
4 weeks
Dose Expansion
ELVN-001 administered at the recommended dose in CML with and without T315I mutations
up to 3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Participant Groups
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).
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Health Network (UHN) - Princess Margaret Cancer CentreToronto, Canada
Memorial Sloan Kettering Cancer CenterNew York, NY
The University of Texas MD Anderson Cancer CenterHouston, TX
Oregon Health & Science University-Knight Cardiovascular InstitutePortland, OR
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Who Is Running the Clinical Trial?
Enliven TherapeuticsLead Sponsor
References
Efficacy of escalated imatinib combined with cytarabine in newly diagnosed patients with chronic myeloid leukemia. [2022]In order to improve the molecular response rate and prevent resistance to treatment, combination therapy with different dosages of imatinib and cytarabine was studied in newly diagnosed patients with chronic myeloid leukemia in the HOVON-51 study.
Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet. [2023]To review and update the European LeukemiaNet (ELN) recommendations for the management of chronic myeloid leukemia with imatinib and second-generation tyrosine kinase inhibitors (TKIs), including monitoring, response definition, and first- and second-line therapy.
Monitoring response to tyrosine kinase inhibitor therapy, mutational analysis, and new treatment options in chronic myelogenous leukemia. [2019]Unlike in other leukemias, survival rates have climbed dramatically in early-phase chronic myelogenous leukemia (CML). This improvement in long-term prognosis is primarily the result of the tyrosine kinase inhibitor (TKI) imatinib and its second-generation cousins nilotinib and dasatinib. In his presentation at the NCCN 18th Annual Conference, Dr. Jerald P. Radich reviewed the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) recommendations for monitoring response to treatment with the TKIs, which center on complete cytogenetic response, and the role of mutational analysis for guiding treatment decisions in the setting of imatinib resistance. He also offered a brief mention of 2 new agents recently approved for resistant CML--ponatinib and bosutinib.
Sequential therapy in chronic myelogenous leukemia: where do emerging therapies fit within current treatment regimens? [2017]Chronic myelogenous leukemia (CML) is a slowly progressing malignancy that most often includes a clonal genetic aberration (the Philadelphia chromosome) that results in the BCR-ABL fusion protein, a constitutively activated tyrosine kinase. The management of CML was revolutionized more than a decade ago with the introduction of imatinib, a targeted inhibitor of the BCR-ABL protein. Imatinib has improved outcome and increased survival, but a substantial number of patients will develop resistance or intolerance to therapy. The second-generation tyrosine kinase inhibitors nilotinib and dasatinib are now approved in both the first-line and second-line settings. More recently, ponatinib and bosutinib were approved for resistant or refractory disease. This expansion to the treatment armamentarium has raised questions regarding the best selection and sequencing of agents. Clinical trials are now beginning to address these issues and others. The many treatment options in CML can offer patients improved outcomes, greater quality of life, and increased survival.
Contemporary insights into the pathogenesis and treatment of chronic myeloproliferative neoplasms. [2019]This review is based on the deliberations at the 5th John Goldman Colloquium held in Estoril on 2nd October 2015 and the 9th post-ASH International Workshop on chronic myeloid leukemia (CML) and BCR-ABL1-negative myeloproliferative neoplasms (MPN) which took place on the 10th-11th December 2014, immediately following the 56th American Society of Hematology Annual Meeting. It has been updated since and summarizes the most recent advances in the biology and therapy of these diseases, in particular updates of genetics of MPN, novel insights from mouse MPN models, targeting CML stem cells and its niche; clinical advances include updates on JAK2 inhibitors and other therapeutic approaches to BCR-ABL1-negative MPNs, the use of alpha interferons, updates on tyrosine kinase inhibitors (TKI) randomized trials in CML, TKI cessation studies, and optimal monitoring strategies.