AML Treatment in Untreated Adult Patients
LAM99P
1 other identifier
interventional
N/A
1 country
36
Brief Summary
The present therapy intends to be an homogeneous treatment for AML patients based on a pretreatment with hydroxiurea plus an induction therapy with the standard arm with Daunorubicine as according to EORTC-GIMEMA AML10 study. The post-remissional treatment is based on transplant with HLA compatible donor is foreseen for all patients and autologous transplant for those without HLA compatible donor available.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 1998
Longer than P75 for not_applicable
36 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
November 1, 1998
CompletedFirst Submitted
Initial submission to the registry
March 19, 2007
CompletedFirst Posted
Study publicly available on registry
March 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedNovember 17, 2017
November 1, 2017
19.6 years
March 19, 2007
November 14, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- AML "de novo" with bone marrow blasts \<=30%
- Performance status: 0-3
- FAB subtype: all except M3
- Written informed consent
You may not qualify if:
- age \<15 years and \>= 61 years
- pretreated AML with chemiotherapy (except Idrossiurea) or radiotherapy or corticosteroids for more than 7 days.
- diagnosis of acute promyelocitic leukemia (M3)
- Performance status = 4
- Uncontrolled infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Prof. Mozzana
Gallarate, Italy
Dr. De Blasio
Latina, Italy
Prof. Nalli
Lodi, Italy
Prof. Bordigon
Milan, Italy
Dr Miraglia
Napoli, Italy
Dr. Mettivier
Napoli, Italy
Dr.ssa Mastrullo
Napoli, Italy
Prof. Pane
Napoli, Italy
Prof. D'Arco
Nocera Inferiore, Italy
Dr Avanzi
Novara, Italy
Dr. Gabbas
Nuoro, Italy
Prof. Saglio
Orbassano, Italy
Dr Mirto
Palermo, Italy
Prof. Citarrella
Palermo, Italy
Prof. Mariani
Palermo, Italy
Prof. Rizzoli
Parma, Italy
Pr. Mecucci
Perugia, Italy
Prof. Falini
Perugia, Italy
Prof. Martelli
Perugia, Italy
Dr. Fioritoni
Pescara, Italy
Pr. Petrini
Pisa, Italy
Dr. Ricciuti
Potenza, Italy
Dr. Nobile
Reggio Calabria, Italy
Dr. Andriani
Roma, Italy
Dr. Majolino
Roma, Italy
Pr. Amadori
Roma, Italy
Pr. Annino
Roma, Italy
Pr. Leone
Roma, Italy
Pr. Lo Coco
Roma, Italy
Dr. Santoro
Rozzano, Italy
Pr. Carella
San Giovanni Rotondo, Italy
Pr. Longinotti
Sassari, Italy
Dr Epis
Sondalo, Italy
Dr. Russo
Taormina, Italy
Dr Mazza
Taranto, Italy
Pr. Boccadoro
Torino, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franco MANDELLI, Pr.
Gruppo Italiano Malattie EMatologiche dell'Adulto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 19, 2007
First Posted
March 20, 2007
Study Start
November 1, 1998
Primary Completion
June 1, 2018
Study Completion
July 1, 2018
Last Updated
November 17, 2017
Record last verified: 2017-11