Clinical trial NCT01700413: Efficacy and Toxicity of Increasing Doses of Idarubicin, Cytarabine and G-CSF in Acute Myeloid Leukemia
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Di Novo Acute Myeloid Leukemia
Keywords: acute
myeloid
leukemia
CETLAM
Idarubicin
Lead sponsor: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Spain
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2012-10-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of complete remissions (CR)
timeFrame: From 28 up to 56 days after first induction
Secondary outcomes:
measure: Rate of patients with adverse events as a measure of safety and tolerability
timeFrame: Weekly during treatment, and on months 3 and 6 after complete response
measure: Duration of hospitalization
timeFrame: From the inclusion until 9 months after inclusion.
measure: Mortality (as rate) related to study treatment
timeFrame: Weekly during treatment, 3 months after complete remission, 6 months after complete remission and 9 months after complete remission
measure: Relapse at 6 months
timeFrame: 6 months from complete remission, expected to be within 9 months from inclusion.
measure: Survival at 9 months from diagnosis
timeFrame: 9 months after diagnoses
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol de Badalona
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospitals Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Salut Brunet, MD
role: STUDY_CHAIR
References: