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 (LAMVYX)
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|ClinicalTrials.gov Identifier: NCT04230239|
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Newly Diagnosed Secondary or High Risk AML||Drug: CPX-351||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
This protocol corresponds to a prospective, multicenter, open-label, phase II study to assess efficacy of CPX-351 in elderly patients (60 to 75 years of age) with newly diagnosed high risk AML. In the context of this protocol, a treatment cycle is defined as the first day of study drug administration (Day 1) up to and including the day before the first day of the treatment cycle immediately afterwards. The treatment cycles will begin after Day 42 but no later than Day 80, counting from Day 1 of the treatment cycle immediately before.
Treatment cycles may be administered while the patient is hospitalized. Patients will receive a maximum of 4 treatment cycles (up to 2 inductions and 2 consolidations) and 6 maintenance cycles. Clinical conditions in the care of patients with acute leukemia require the need for flexibility. However, deviations from the study treatment defined in this section must be prospectively discussed with the coordinator.
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Multicentre, Open Label 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|
|Actual Study Start Date :||December 26, 2019|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||December 2022|
CPX-351 has IV administration Vyxeos contains 2.2 mg/mL and 5 mg/mL powder for concentrate for solution for infusion of Daunorubicin and cytarabine.
Each vial contains 44 mg of daunorubicin and 100 mg of cytarabine. After reconstitution, the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine
- To evaluate the CR/CRi rate after induction with CPX-351 [ Time Frame: After 1 or 2 cycles of induction (between 12 and 16 weeks approximately) ]The primary endpoint of the study is to evaluate the CR/CRi rate after induction with CPX-351. The responses for CR, CRi, PR, therapeutic failure, and disease recurrence are defined for this study based on the revised recommendations of the International Working Group for response criteria.
- Incidence of Treatment-Adverse Events (Safety and Tolerability) of the CPX-351 induction regimen. [ Time Frame: The induction cycles (up to 2 cycles) will have a mean estimated duration of 6 weeks per cycle. Safety/toxicity assessments will be done in day 1, 8, 15, 22, 29 and 36 of the induction cycles. ]Incidence and description of adverse events occurred during induction regimen.
- To evaluate the effect of priming with G-CSF with the CPX-351 regimen [ Time Frame: Priming with G-CSF will be done in the induction cycles (up to 2 cycles) and in the consolidation cycles (up to 2 cycles) that will have an an estimated duration of 6 weeks per cycle. ]Differences of leukocytes values (x10^9/L) from baseline values, will be checked in order to know the effect of priming with G-CSF
- Incidence of Treatment-Adverse Events (Safety and Tolerability) of the CPX-351 consolidation regimen [ Time Frame: Safety/toxicity assessments will be done in day 1, 8, 15, 22, 29 and 36 of the consolidation cycles ]Incidence and description of adverse events occurred during consolidation regimen.
- Incidence of Treatment-Adverse Events (Safety and Tolerability) of the CPX-351 maintenance regimen [ Time Frame: Safety/toxicity assessments will be done every 2 weeks during the manteinance cycles (24 to 40 weeks of maintenance). ]Incidence and description of adverse events occurred during maintenance regimen.
- Overall survival [ Time Frame: Estimated 1, 2 and 3 year OS ]
- Event-free, disease-free, and relapse free survival (RFS), as well as on the duration of remission and cumulative incidence of relapse [ Time Frame: 1, 2 and 3 years ]
- Incidence of hematologic and non-hematologic adverse events occurred during the study. [ Time Frame: At 9 months, which is approximately the estimated mean treatment time. ]Incidence and description of hematologic and non-hematologic adverse events occurred during the study.
- To evaluate the impact on the quality of life, using the European Quality of Life-5 Dimensions (EQ5D) form, in patients treated with CPX-351 [ Time Frame: The cycles will have a mean estimated duration of 6 weeks and Quality of life questionnaire following EQ-5D will be performed at screening, after induction (day 36), after consolidation 2 ( day 36 of cycle 3) and/or prior to allo-SCT ]European Quality of Life-5 Dimensions (EQ-5D)
- To evaluate the impact on the use of medical resources during induction and consolidation phase. [ Time Frame: The cycles will have a mean estimated duration of 6 weeks and patients may have up to 2 cycles of induction and up to 2 cycles of consolidation. ]Frequencies and descriptions of medical resources (antibiotics, transfusions, etc)
- To evaluate the quality of CR (by study of minimal residual disease percentages in the bone marrow using multiparametric flow cytometry) [ Time Frame: After first cycle of induction (6 weeks) and after consolidation 1 (cycle 2: 6 weeks after consolidation 1 onset) only in patients achieving CR/CRi after consolidation 1 ]
- To evaluate early mortality (first 60 days) in patients initially treated with CPX-351 [ Time Frame: Day 60 ]
- To compare the results with a matched-paired historical cohort of the PETHEMA registry [ Time Frame: Once the study is completed ( an average of 30 months through study completion) ]Comparison of the different results between patients included in the CPX-351 trial and a retrospective cohort of patients with similarities characteristics at diagnosis (paired analysis). For this purposes, data will be obtained from the retrospective control cohort of the PETHEMA Epidemiologic Registry of Adult AML. Patients will be matched by age (≤65 vs >65, secondary AML vs therapy-related AML vs high-risk according to 2017ELN).
- To assess the rate of allo-SCT [ Time Frame: After consolidation 1 (aprox 12 weeks) or after consolidation 2 (aprox 18 weeks) ]
- To evaluate 100 day mortality after allo-SCT [ Time Frame: 100 day after allo-SCT ]
- To assess compliance of the maintenance schedule [ Time Frame: After maintenance (aprox 36 weeks) ]Measure the number and percentage of patients that start maintenance cycles, and how many discontinues during the manteinance phase or complete all manteinance according to protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230239
|Contact: Olga García Calduch||0034 email@example.com|
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|Contact: Susana Vives Polo|
|Institut Català D'Oncologia - Hospital Duran I Reynals||Not yet recruiting|
|Contact: Montserrat Arnan Sangerman|
|Hospital San Pedro de Alcántara||Not yet recruiting|
|Contact: Juan Miguel Bergua Burgués|
|Hospital Universitario Reina Sofía||Not yet recruiting|
|Contact: Josefina Serrano López|
|Hospital Universitario de Gran Canaria Dr. Negrín||Not yet recruiting|
|Las Palmas, Spain|
|Contact: Carlos Rodríguez Medina|
|Hospital Universitario Lucus Augusti||Not yet recruiting|
|Contact: Maria Esperanza Lavilla Rubira|
|Hospital Ramón Y Cajal||Not yet recruiting|
|Contact: Pilar Herrera Puente|
|Hospital Universitario 12 de Octubre||Not yet recruiting|
|Contact: Pilar Martínez Sánchez|
|Hospital Universitario Central de Asturias||Not yet recruiting|
|Contact: Teresa Bernal del Castillo|
|Hospital General Del H.U. Virgen Del Rocío||Not yet recruiting|
|Contact: José Antonio Pérez Simón|
|Hospital Clínico Universitario de Valencia||Not yet recruiting|
|Contact: Mar Tormo Díaz|
|Hospital Universitario Y Politécnico La Fe||Recruiting|
|Contact: Rebeca Rodríguez Veiga|
|Principal Investigator:||Pau Montesinos Fernández, PhD||Hospital Universitario La Fe|
|Principal Investigator:||José Antonio Pérez Simón, PhD||Hospitales Universitarios Virgen del Rocío|
|Study Chair:||Carmen López-Carrero García||Fundación Pethema|