NCT01723657|CompletedPhase 2
Loading search results
Sponsor study identifier
interventional
862
1 country
21
Study Start
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)The AML-03 regimen investigates the addition of G-CSF priming to both induction and consolidation chemotherapies administrated in the previous AML-99 trial (NCT01716793) refines risk-stratification based on biological characterization also the AML-03 trial incorporates novel approaches for hematopoietic stem cell transplantation: such as Mylotarg™ "in vivo purging" in autografts, extends unrelated volunteers donors for allotransplants in high-risk patients, and introduces reduced intensity conditioning in patients with elder age (more than 50 years old). The aims of these modifications are to analyse eficacy and toxicity of this induction and consolidation therapy and to analyse the disease free survival in patients who achieved complete response following a risk adjusted therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
March 2012
Actual (reported)March 2012
Actual (reported)October 31, 2012
Actual (reported)November 8, 2012
Actual (reported)Complete remission rate (CRR)
Analyze the efficacy and toxicity of IDICE-G (idarubicin, intermediate doses of ara-C and etoposide) and G-CSF to achieve complete remission.
2 months.
Disease free survival (DFS).
Analyze the disease free suvival of patients in remission, with a therapeutic strategy adjusted to the prognostic factors. Mortality in remission after chemotherapy and/or peripheral blood stem cell tranplantation.
4 years.
Toxicity in patients over 60 years old.
4 years.
Evaluation of minimal residual disease (MRD) by flow cytometry and/or molecular markers during and after treatment.
4 years.
Feasibility of post-remission treatment in patients with 60 or more years old.
4 years.
Ara-C, G-CSF, Autologous peripheral blood stem cell transplantation, Allogeneic matched related or unrelated donor transplant, G-CSF Priming, CD34+ selection, Myeloablative or reduced intensity conditioning, Mylotarg purging before autologous PBSC transplantation.
* Intermediate dose during induction phase to remission. * High dose during consolidation phase in patients with favorable cytogenetics and leukocyte index below 20.
* In patients with favorable cytogenetics with a Leukocyte index above 20. * Patients with normal karyotype, and one cycle of chemotherapy to achieve complete remission, without adverse molecular and/or minimal residual disease (MRD) characteristics, regardless availability of a matched donor.
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Centro Medico Teknon
Barcelona, Barcelona, 08022, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036, Spain
ICO Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, Barcelona, 08907, Spain
Jorge Sierra, MD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Salut Brunet, MD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
862 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2012
First Posted
November 8, 2012
Study Start
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)
-Patients without favorable/intermediate characteristics.
* Administration at induction phase to remission, days 0 to 7. G-CSF will not be initiated if the leukocyte count is over 30x10e9/L at diagnosis or will be interrupted if the leukocyte count during treatmen arises 30x10e9/L. * Administration at consolidation phase, days 4 to 6 (3 doses). G-CSF will be interrupted if the leukocyte count during treatment arises 30x10e9/L.
-Patients with adverse prognosis with allogeneic peripheral blood stem cell (PBSC)tranplantation, CD34+ cell selection of the inoculum was performed.
Patients without favorable/intermediate characteristics and without matched related donor.
Contact the study team to confirm eligibility.
Hospital A Coruña
A Coruña, Coruña, 15006, Spain
Hopital Universitari de Girona Dr. Josep Trueta
Girona, Girona, 17007, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Lleida, 25006, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, 29010, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Mallorca, 07198, Spain
Hospital Universitari Son Dureta
Palma de Mallorca, Mallorca, Spain
Hospital General Universitario de Murcia
Murcia, Murcia, 30008, Spain
Hospital Universitario Virgen del Rocio
Seville, Sevilla, 41014, Spain
Hospital Universitari Joan XXIII
Tarragona, Tarragona, 43007, Spain
Hospital Verge de la Cinta
Tortosa, Tarragona, 43517, Spain
Mutua de Terrassa
Terrassa, Terrassa, 08225, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Hospital Universitario Rio Hortega
Valladolid, Valladolid, 41010, Spain
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)Last Updated
November 8, 2012
Record last verified: 2012-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: