Di Novo Acute Myeloid Leukemia
Conditions
Keywords
acute, myeloid, leukemia, CETLAM, Idarubicin
Brief summary
While several studies have been reported with increasing doses of daunorubicin in the first line treatment of Acute Myeloid Leukemia (AML), there is no similar experience with idarubicin as initial treatment of AML. As idarubicin is the most common treatment used for AML, it is needed to find the optimal dose for the combination of idarubicin, cytarabine and G\_CSF, to explore if this combination improves the outcomes of current treatments for AML. The aim of this dose-finding study is to find the optimal dose for the combination of idarubicin, cytarabine and G-CSF that could improve the response rate, reduce relapse and improve survival of patients with primary acute myeloid leukemia. This could be a significant advance in a field where treatment outcomes have stabilized in the last 15 years. This study will be the basis for further prospective, randomized, multicenter trial comparing idarubicin maximum tolerated dose, compared to standard treatment with idarubicin and cytarabine, including raising both arms in G-CSF. The dose of 12 mg/m2 will be administered as control arm in this future randomized study, which will investigate the benefit of enhanced dose identified as optimal in this phase II pilot study.
Interventions
DRUGIdarubicin
Sponsors
Ministry of Health, Spain
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Informed consent signature Patients with newly diagnosed AML, classified according to WHO criteria. Age more than or equal to 18 and less than or equal to 70 years.
Exclusion criteria
Patients previously treated with chemotherapy for their AML other than hydroxyurea. Acute promyelocytic leukemia with t (15; 17). Blast crisis of chronic myeloid leukemia. Leukemias that appear after other myeloproliferative neoplasms. Leukemias ensuing myelodysplastic syndromes after more than 6 months. Presence of other malignancies in activity. AML secondary to chemo-radiotherapy treatment for other malignancies. Abnormal renal and hepatic function, with creatinine value and / or bilirubin 2 times the normal limit value, except where the alterations are attributable to leukemia. Patients with markedly reduced ejection fraction (less than 45%), symptomatic heart failure, or both of the normal value of the center. Patients with serious concomitant psychiatric or neurological disease. HIV-positive. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete remissions (CR) | From 28 up to 56 days after first induction | Identify the highest dose of idarubicin in combination with cytarabine and G-CSF that produces a CR rate equal to or greater than 65% with tolerable toxicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with adverse events as a measure of safety and tolerability | Weekly during treatment, and on months 3 and 6 after complete response | Hematologic toxicity Gastrointestinal and liver toxicity Cardiac Toxicity Fever and infection Pulmonary complications Duration of hospitalization Mortality and causes of death induction. |
| Duration of hospitalization | From the inclusion until 9 months after inclusion. | Number of days in which the patient is hospitalized. |
| Mortality (as rate) related to study treatment | Weekly during treatment, 3 months after complete remission, 6 months after complete remission and 9 months after complete remission | Causes of death, mortality related treatment, mortality in induction. |
| Relapse at 6 months | 6 months from complete remission, expected to be within 9 months from inclusion. | Rate of patients that have relapsed within 6 months after complete remission. |
| Survival at 9 months from diagnosis | 9 months after diagnoses | Rate of patients alive at 9 months after diagnosis. |
Countries
Spain
Outcome results
None listed