Efficacy and Toxicity of Increasing Doses of Idarubicin, Cytarabine and G-CSF in Acute Myeloid Leukemia
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Di Novo Acute Myeloid Leukemia |
Drug: Idarubicin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
- Rate of complete remissions (CR) [ Time Frame: From 28 up to 56 days after first induction ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: Yes ]Hematologic toxicity Gastrointestinal and liver toxicity Cardiac Toxicity Fever and infection Pulmonary complications Duration of hospitalization Mortality and causes of death induction.
- Duration of hospitalization [ Time Frame: From the inclusion until 9 months after inclusion. ] [ Designated as safety issue: No ]Number of days in which the patient is hospitalized.
- 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 ] [ Designated as safety issue: Yes ]Causes of death, mortality related treatment, mortality in induction.
- Relapse at 6 months [ Time Frame: 6 months from complete remission, expected to be within 9 months from inclusion. ] [ Designated as safety issue: No ]Rate of patients that have relapsed within 6 months after complete remission.
- Survival at 9 months from diagnosis [ Time Frame: 9 months after diagnoses ] [ Designated as safety issue: No ]Rate of patients alive at 9 months after diagnosis.
| Estimated Enrollment: | 45 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01700413
| Contact: Salut Brunet, MD | + 34 93 434 44 12 | investigacion@mfar.net | |
| Contact: Federico Nepote, PhD | + 34 93 434 44 12 | federico.nepote@mfar.net |
| Spain | |
| Hospital Universitari Germans Trias I Pujol de Badalona | Recruiting |
| Badalona, Spain, 08916 | |
| Contact: Susana Vives, MD +34934344412 investigacion@mfar.net | |
| Principal Investigator: Susana Vives, MD | |
| Hospital Clinic I Provincial de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Jordi Esteve, MD +34934344412 investigacion@mfar.net | |
| Principal Investigator: Jordi Esteve, MD | |
| Hospital de La Santa Creu I Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Salut Brunet, MD +34934344412 investigacion@mfar.net | |
| Principal Investigator: Salut Brunet, MD | |
| Hospitals Vall D'Hebron | Not yet recruiting |
| Barcelona, Spain, 08035 | |
| Contact: Olga Salamero, MD +34934344412 investigacion@mfar.net | |
| Principal Investigator: Olga Salamero, MD | |
| Hospital Clínico Universitario de Valencia | Recruiting |
| Valencia, Spain, 46010 | |
| Contact: Mar Tormo, MD +34934344412 investigacion@mfar.net | |
| Principal Investigator: Mar Tormo, MD | |
| Study Chair: | Salut Brunet, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
More Information
No publications provided
| Responsible Party: | Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias |
| ClinicalTrials.gov Identifier: | NCT01700413 History of Changes |
| Other Study ID Numbers: | IIBSP-CSF-2011-141 |
| Study First Received: | October 1, 2012 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines Spain: Ethics Committee |
Keywords provided by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias:
|
acute myeloid leukemia CETLAM Idarubicin |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Cytarabine Idarubicin Anti-Infective Agents Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic |
Antineoplastic Agents Antiviral Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on February 25, 2015