Efficacy and Toxicity of Increasing Doses of Idarubicin, Cytarabine and G-CSF in Acute Myeloid Leukemia

NCT01700413 | Completed Phase 2

• 1 other identifier: IIBSP-CSF-2011-141
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

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.

Conditions

Di Novo Acute Myeloid Leukemia

Keywords

acute; myeloid; leukemia; CETLAM; Idarubicin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• Duration of hospitalization

  From the inclusion until 9 months after inclusion.

• 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

• Relapse at 6 months

  6 months from complete remission, expected to be within 9 months from inclusion.

• Survival at 9 months from diagnosis

  9 months after diagnoses

Study Arms (1)

Idarubicin

EXPERIMENTAL

Cohort 1: Idarubicin 14 mg/m2 (day 1-3), Cytarabine 200 mg/m2 (Days 1-7), G-CSF 150 mcg/m2/day Cohort 2: Idarubicin 16 mg/m2 (day 1-3), Cytarabine 200 mg/m2 (Days 1-7), G-CSF 150 mcg/m2/day Cohort 3: Idarubicin 18 mg/m2 (day 1-3), Cytarabine 200 mg/m2 (Days 1-7), G-CSF 150 mcg/m2/day

Drug: Idarubicin

Interventions

Idarubicin DRUG

Idarubicin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias: lead
• Ministry of Health, Spain: collaborator
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator

Study Sites (5)

Hospital Universitari Germans Trias I Pujol de Badalona

Badalona, Badalona, 08916, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospitals Vall D'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Leukemia

Interventions

Idarubicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Salut Brunet, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 4, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

ES (5)