Di Novo Acute Myeloid Leukemia Clinical Trial
Official title:
Treatment of di Novo Acute Myeloid Leukemia With the Combination of Increasing Doses of Idarubicin, Cytarabine and Sensitization (Priming) With G-CSF. A Phase II Prospective Study of Toxicity and Efficacy.
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | April 2015 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitari Germans Trias I Pujol de Badalona | Badalona | |
| Spain | Hospital Clinic I Provincial de Barcelona | Barcelona | |
| Spain | Hospital de La Santa Creu I Sant Pau | Barcelona | |
| Spain | Hospitals Vall D'Hebron | Barcelona | |
| Spain | Hospital Clínico Universitario de Valencia | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Ministry of Health, Spain |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of complete remissions (CR) | 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. | From 28 up to 56 days after first induction | No |
| Secondary | Rate of patients with adverse events as a measure of safety and tolerability | Hematologic toxicity Gastrointestinal and liver toxicity Cardiac Toxicity Fever and infection Pulmonary complications Duration of hospitalization Mortality and causes of death induction. | Weekly during treatment, and on months 3 and 6 after complete response | Yes |
| Secondary | Duration of hospitalization | Number of days in which the patient is hospitalized. | From the inclusion until 9 months after inclusion. | No |
| Secondary | Mortality (as rate) related to study treatment | Causes of death, mortality related treatment, mortality in induction. | Weekly during treatment, 3 months after complete remission, 6 months after complete remission and 9 months after complete remission | Yes |
| Secondary | Relapse at 6 months | Rate of patients that have relapsed within 6 months after complete remission. | 6 months from complete remission, expected to be within 9 months from inclusion. | No |
| Secondary | Survival at 9 months from diagnosis | Rate of patients alive at 9 months after diagnosis. | 9 months after diagnoses | No |