Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML)
NCT ID: NCT01723657
Last Updated: 2012-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
862 participants
INTERVENTIONAL
2003-10-31
2012-03-31
Brief Summary
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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.
Detailed Description
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Consolidation therapy (as in AML-99 trial): mitoxantrone (12mg/m2/day, intravenous, days 4 to 6) and intermediate-dose cytarabine (500mg/m2/12h from day 1 to 6).
Risk-stratification according to cytogenetics, courses to CR and availability of an HLA-identical sibling:
* Patients in the favorable cytogenetics group \[t(8;21), inv(16) or t(16;16)\] and Leukocyte index \<20 at diagnosis (LI=white blood cell count (WBC) x (blasts in bone marrow/100) are treated with one course of high-dose cytarabine (3g/m2/12h, intravenous, days 1, 3 and 5), but in case of LI\>20 at diagnosis the intention is to perform an autologous peripheral blood stem cell (PBSC) transplantation.
* Patients in intermediate risk group, with normal karyotype, a single course of induction chemotherapy to achieve the CR, the absence of adverse molecular features (FLT3-ITD or MLL-PTD) and low minimal residual disease levels after consolidation (MRD\<0,1%) receive an autologous PBSC transplant, regardless of having an HLA-identical sibling.
* The remaining patients defined as high-risk patients are treated with an allogeneic stem cell transplantation. Depending on the age, if the patient has an HLA-identical sibling donor, up to age of 50 years old it is performed with conventional conditioning therapy and positive selection of CD34+, older patients receive a reduced intensity conditioning regimen.
* Very high risk patients without a sibling are allocated to unrelated donor (9-10/10). Patients with adverse cytogenetics and/or FLT3-ITD without an adequate donor received Mylotarg™ as "in vivo purging" followed by an autologous PBSC transplantation.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Risk-adapted postremission treatment.
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.
Ara-C
* Intermediate dose during induction phase to remission.
* High dose during consolidation phase in patients with favorable cytogenetics and leukocyte index below 20.
Autologous peripheral blood stem cell transplantation.
* 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.
Allogeneic matched related or unrelated donor transplant.
-Patients without favorable/intermediate characteristics.
G-CSF
* 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.
CD34+ selection.
-Patients with adverse prognosis with allogeneic peripheral blood stem cell (PBSC)tranplantation, CD34+ cell selection of the inoculum was performed.
Mylotarg purging before autologous PBSC transplantation
Patients without favorable/intermediate characteristics and without matched related donor.
Interventions
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Ara-C
* Intermediate dose during induction phase to remission.
* High dose during consolidation phase in patients with favorable cytogenetics and leukocyte index below 20.
Autologous peripheral blood stem cell transplantation.
* 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.
Allogeneic matched related or unrelated donor transplant.
-Patients without favorable/intermediate characteristics.
G-CSF
* 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.
CD34+ selection.
-Patients with adverse prognosis with allogeneic peripheral blood stem cell (PBSC)tranplantation, CD34+ cell selection of the inoculum was performed.
Mylotarg purging before autologous PBSC transplantation
Patients without favorable/intermediate characteristics and without matched related donor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with 70 years old or younger.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
OTHER
Responsible Party
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Principal Investigators
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Jorge Sierra, MD
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Salut Brunet, MD
Role: STUDY_CHAIR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Locations
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Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Centro Medico Teknon
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain
ICO Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, Barcelona, Spain
Hospital A Coruña
A Coruña, Coruña, Spain
Hopital Universitari de Girona Dr. Josep Trueta
Girona, Girona, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Lleida, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Mallorca, Spain
Hospital Universitari Son Dureta
Palma de Mallorca, Mallorca, Spain
Hospital General Universitario de Murcia
Murcia, Murcia, Spain
Hospital Universitario Virgen del Rocio
Seville, Sevilla, Spain
Hospital Universitari Joan XXIII
Tarragona, Tarragona, Spain
Hospital Verge de la Cinta
Tortosa, Tarragona, Spain
Mutua de Terrassa
Terrassa, Terrassa, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitario Rio Hortega
Valladolid, Valladolid, Spain
Countries
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Other Identifiers
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AML-03
Identifier Type: -
Identifier Source: org_study_id