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NCT Number: NCT01700413

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

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.

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Key information

Conditions

Di Novo Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitari Germans Trias I Pujol de Badalona, Badalona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Idarubicin

Drug

Primary outcomes

  1. Rate of complete remissions (CR)

    Time frame: 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 outcomes

  1. Rate of patients with adverse events as a measure of safety and tolerability

    Time frame: 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.

  2. Duration of hospitalization

    Time frame: From the inclusion until 9 months after inclusion.

    Number of days in which the patient is hospitalized.

  3. Mortality (as rate) related to study treatment

    Time frame: 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.

  4. Relapse at 6 months

    Time frame: 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.

  5. Survival at 9 months from diagnosis

    Time frame: 9 months after diagnoses

    Rate of patients alive at 9 months after diagnosis.

Sponsors and collaborators

Lead sponsor

Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

Other

Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Ministry of Health, Spain

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Oct 4, 2012
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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