EICHOR
● Completed
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
Condition: Newly Diagnosed Secondary or High Risk AML · Sponsor: PETHEMA Foundation
About this study
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 f…
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (12)
| Institut Català D'Oncologia-Hospital Germans Trias I Pujol | Badalona, Spain | — |
| Institut Català D'Oncologia - Hospital Duran I Reynals | Bellvitge, Spain | — |
| Hospital San Pedro de Alcántara | Cáceres, Spain | — |
| Hospital Universitario Reina Sofía | Córdoba, Spain | — |
| Hospital Universitario de Gran Canaria Dr. Negrín | Las Palmas, Spain | — |
| Hospital Universitario Lucus Augusti | Lugo, Spain | — |
| Hospital Ramón Y Cajal | Madrid, Spain | — |
| Hospital Universitario 12 de Octubre | Madrid, Spain | — |
| Hospital Universitario Central de Asturias | Oviedo, Spain | — |
| Hospital General Del H.U. Virgen Del Rocío | Seville, Spain | — |
| Hospital Clínico Universitario de Valencia | Valencia, Spain | — |
| Hospital Universitario Y Politécnico La Fe | Valencia, Spain | — |
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Source record: clinicaltrials.gov/study/NCT04230239