Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML)
1 other identifier
interventional
862
1 country
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2003
Longer than P75 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 31, 2012
CompletedFirst Posted
Study publicly available on registry
November 8, 2012
CompletedNovember 8, 2012
October 1, 2012
8.4 years
October 31, 2012
November 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Secondary Outcomes (3)
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.
Study Arms (1)
Risk-adapted postremission treatment.
OTHERAra-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.
Interventions
* 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.
-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.
Eligibility Criteria
You may qualify if:
- Patients with newly diagnosed AML, classified using OMS criteria.
- Patients with 70 years old or younger.
You may not qualify if:
- Patients previously treated for the AML with chemotherapy different from hidroxiurea.
- Acute promyelocytic leukemia with t(15;17).
- Cronic mieloid leukemia in blastic crisis.
- Leukemias that appear after other myeloproliferative processes.
- Leukemias that survive after myelodysplasic syndromes of more than 6 months of evolution.
- Presence of other neoplasic disease in activity.
- Secondary AML which appears after cured malignant disease (for instance, Hodgking disease), and those who are still exposed to alkilant agents or radiation.
- Abnormal renal and hepatic functions with creatinin and/or bilirrubine 2 times higher than the normal threshold, except when the alteration should be attributed to the leukemia.
- Patient with an ejection fraction below 40%, symptomatic cardiac deficiency or both.
- Patients with neurological or concomitant psychiatric disease.
- Positivity by HIV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge Sierra, MD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- STUDY CHAIR
Salut Brunet, MD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 31, 2012
First Posted
November 8, 2012
Study Start
October 1, 2003
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
November 8, 2012
Record last verified: 2012-10