NCT04230239: LAMVYX

Clinical Trial to Assess the Efficacy and Toxicity of Induction and Consolidation With CPX-351 for Patients Aged 60 to 75 Years With Secondary or High-risk Acute Myeloid Leukemia

Completed Phase 2 Last updated 8 September 2022

What this trial tests

Phase 2 trial testing CPX-351 in Newly Diagnosed Secondary or High Risk AML in 59 participants. Completed in 11 August 2021.

Timeline

26 December 2019

Primary endpoint
30 April 2021

11 August 2021

Quick facts

Lead sponsor	PETHEMA Foundation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	59
Start date	26 December 2019
Primary completion	30 April 2021
Estimated completion	11 August 2021
Sites	12 locations across Spain

Drugs / interventions tested

• CPX-351 (cpx-351) — full drug profile →

Conditions studied

• Newly Diagnosed Secondary or High Risk AML — all drugs for Newly Diagnosed Secondary or High Risk AML →

Sponsor

PETHEMA Foundation

Who can join

Adults 60 to 75, any sex, with Newly Diagnosed Secondary or High Risk AML. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This protocol corresponds to a prospective, multicentre, open label, phase II study designed to evaluate the efficacy of CPX-351 in elderly patients with secondary or high-risk AML. The clinical trial is divided into pre-treatment, treatment (induction and consolidation cycles) and follow-up periods and consists of a single arm group. Patients will be enrolled at diagnosis to follow the treatment arm. After that will start induction chemotherapy with CPX-351 regimen (14 days maximum screening period). Once a patient have been evaluated for response and recovered from major complications, he/she will start second course (consolidation 1), unless the bone marrow and peripheral blood assessment is showing less than a complete response, then a second induction may be offered. If a CR or CRi is obtained after the second induction course, patients will start the third course after a rest and recovery period. Patients aged between 60 and 65 years old are recommended to undergo an allo-SCT after first consolidation if they are considered fit for this procedure and they have a full matched related or unrelated donor. Patients aged between 65 and 70 years old can be proposed for an allo-SCT in CR/CRi if they have a composite HSCT co-morbidity index /age less than 4 and a suitable fully matched related donor. In patients over 70 years old, an allo-SCT in first CR should be avoided although the decision should be taken on an individual basis. Patients with CR/CRi who are not considered for an allo-SCT, will follow 6 maintenance cycles with modified courses of CPX-351 schedule. Patients showing unacceptable toxicity along all therapeutic phases that, in consideration of the investigator, will be prematurely discontinued. All patients will be followed-up for survival. The study will be analyzed on an intention to treat basis. Bone marrow and response assessments will be done after each induction and consolidation course, and every 3 months during the first 12 months after starting maintenance therapy. Patients will be followed-up for a minimum period of 1 year after the enrolment of the last patient. Additionally, after the end of the trial, patients will be followed-up for 2 years in order to verify survival and the evolution of the disease. Study design allows a maximum of 59 patients.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Networking for advanced molecular diagnosis in acute myeloid leukemia patients is possible: the PETHEMA NGS-AML project
   Sargas C, Ayala R, Chillón MC, Larráyoz MJ, et al · · 2021 · cited 32× · PMID 33179471 · DOI 10.3324/haematol.2020.263806
2. A phase 2, multicenter, clinical trial of CPX-351 in older patients with secondary or high-risk acute myeloid leukemia: PETHEMA-LAMVYX.
   Rodríguez-Arbolí E, Rodríguez-Veiga R, Soria-Saldise E, Bergua JM, et al · · 2025 · cited 3× · PMID 39476204 · DOI 10.1002/cncr.35618
3. The Clinical Safety and Efficacy of Cytarabine and Daunorubicin Liposome (CPX-351) in Acute Myeloid Leukemia Patients: A Systematic Review.
   Alzahrani AM, Alnuhait MA, Alqahtani T. · · 2025 · cited 2× · PMID 40348597 · DOI 10.1002/cnr2.70199