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

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ClinicalTrials.gov Identifier: NCT01700413
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : January 28, 2016
Sponsor:
Collaborators:
Ministry of Health, Spain
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by (Responsible Party):
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

Study Description
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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.


Condition or disease Intervention/treatment Phase
Di Novo Acute Myeloid Leukemia Drug: Idarubicin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : April 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Idarubicin
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700413


Locations
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Spain
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona, Spain, 08916
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08025
Hospitals Vall D'Hebron
Barcelona, Spain, 08035
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Ministry of Health, Spain
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Study Chair: Salut Brunet, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
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Responsible Party: Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
ClinicalTrials.gov Identifier: NCT01700413    
Other Study ID Numbers: IIBSP-CSF-2011-141
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Keywords provided by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias:
acute
myeloid
leukemia
CETLAM
Idarubicin
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Idarubicin
 Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action