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AML Treatment in Untreated Adult Patients (LAM99P)

Primary Purpose

Leukemia, Myelocytic, Acute

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Identification of appropriate therapies according to risks factors
Daunorubicine
Transplant
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Leukemia, Myelocytic, Acute focused on measuring AML, adult, Hydroxyurea, Transplant, Toevaluate biological characteristics at diagnosis., To identify genetic alterations with prognostic relevance., To follow up cases monitoring minimal disease during remission., To evaluate pretreatment therapy in terms of response rate and toxicity., Disease free survival., Overal survival.

Eligibility Criteria

15 Years - 61 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AML "de novo" with bone marrow blasts <=30%
  • Performance status: 0-3
  • FAB subtype: all except M3
  • Written informed consent

Exclusion Criteria:

  • 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

Sites / Locations

  • Prof. MozzanaRecruiting
  • Dr. De BlasioRecruiting
  • Prof. NalliRecruiting
  • Prof. BordigonRecruiting
  • Dr MiragliaRecruiting
  • Dr. MettivierRecruiting
  • Dr.ssa MastrulloRecruiting
  • Prof. PaneRecruiting
  • Prof. D'ArcoRecruiting
  • Dr AvanziRecruiting
  • Dr. GabbasRecruiting
  • Prof. SaglioRecruiting
  • Dr MirtoRecruiting
  • Prof. CitarrellaRecruiting
  • Prof. MarianiRecruiting
  • Prof. RizzoliRecruiting
  • Pr. MecucciRecruiting
  • Prof. FaliniRecruiting
  • Prof. MartelliRecruiting
  • Dr. FioritoniRecruiting
  • Pr. PetriniRecruiting
  • Dr. RicciutiRecruiting
  • Dr. NobileRecruiting
  • Dr. AndrianiRecruiting
  • Dr. MajolinoRecruiting
  • Pr. AmadoriRecruiting
  • Pr. AnninoRecruiting
  • Pr. LeoneRecruiting
  • Pr. Lo CocoRecruiting
  • Dr. SantoroRecruiting
  • Pr. CarellaRecruiting
  • Pr. LonginottiRecruiting
  • Dr EpisRecruiting
  • Dr. RussoRecruiting
  • Dr MazzaRecruiting
  • Pr. BoccadoroRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 19, 2007
Last Updated
November 14, 2017
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT00449319
Brief Title
AML Treatment in Untreated Adult Patients
Acronym
LAM99P
Official Title
AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1998 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
GIMEMA treatment for adult (15-60 yrs) AML patients included a 3-drug induction cycle with DNR (50 mg/m2 d 1, 3, 5), cytarabine (100 mg/m2 d1-10), etoposide (100 mg/m2 d1-5) followed by an intensive consolidation with cytarabine (500 mg/m2/q12 hrs d1-d6) and the same anthracycline as in induction on d 4-6. Following consolidation, eligible pts (age <45 or 55 yrs) with a HLA compatible sibling had to be allografted, the others, had to be autografted with autologous peripheral stem cell (PSC) collected during recovery from consolidation. BM and PB samples at diagnosis were centralized according to a national GIMEMA original study planned with the aim to accurately evaluate biological characteristics at diagnosis and to identify genetic alterations with prognostic relevance and to follow up cases monitoring minimal disease during remission. To allow the adequate collection and sending of samples before starting intensive chemotherapy, all patients received a 5-day pretreatment consisting of hydroxiurea (HU) at the dosage of 2 g/m2/day, also effective for "debulkying" of disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelocytic, Acute
Keywords
AML, adult, Hydroxyurea, Transplant, Toevaluate biological characteristics at diagnosis., To identify genetic alterations with prognostic relevance., To follow up cases monitoring minimal disease during remission., To evaluate pretreatment therapy in terms of response rate and toxicity., Disease free survival., Overal survival.

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Identification of appropriate therapies according to risks factors
Intervention Type
Drug
Intervention Name(s)
Daunorubicine
Intervention Type
Procedure
Intervention Name(s)
Transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AML "de novo" with bone marrow blasts <=30% Performance status: 0-3 FAB subtype: all except M3 Written informed consent Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco VIGNETTI, Dr
Phone
+39 06 441639831
Email
m.vignetti@gimema.it
First Name & Middle Initial & Last Name or Official Title & Degree
Paola FAZI, Dr.
Phone
+39 06 441639830
Email
p.fazi@gimema.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco MANDELLI, Pr.
Organizational Affiliation
Gruppo Italiano Malattie EMatologiche dell'Adulto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Mozzana
City
Gallarate
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr. De Blasio
City
Latina
Country
Italy
Individual Site Status
Recruiting
Facility Name
Prof. Nalli
City
Lodi
Country
Italy
Individual Site Status
Recruiting
Facility Name
Prof. Bordigon
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr Miraglia
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr. Mettivier
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr.ssa Mastrullo
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Name
Prof. Pane
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Name
Prof. D'Arco
City
Nocera Inferiore
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr Avanzi
City
Novara
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr. Gabbas
City
Nuoro
Country
Italy
Individual Site Status
Recruiting
Facility Name
Prof. Saglio
City
Orbassano
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr Mirto
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Name
Prof. Citarrella
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Name
Prof. Mariani
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Name
Prof. Rizzoli
City
Parma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pr. Mecucci
City
Perugia
Country
Italy
Individual Site Status
Recruiting
Facility Name
Prof. Falini
City
Perugia
Country
Italy
Individual Site Status
Recruiting
Facility Name
Prof. Martelli
City
Perugia
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr. Fioritoni
City
Pescara
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pr. Petrini
City
Pisa
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr. Ricciuti
City
Potenza
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr. Nobile
City
Reggio Calabria
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr. Andriani
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr. Majolino
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pr. Amadori
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pr. Annino
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pr. Leone
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pr. Lo Coco
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr. Santoro
City
Rozzano
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pr. Carella
City
San Giovanni Rotondo
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pr. Longinotti
City
Sassari
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr Epis
City
Sondalo
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr. Russo
City
Taormina
Country
Italy
Individual Site Status
Recruiting
Facility Name
Dr Mazza
City
Taranto
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pr. Boccadoro
City
Torino
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

AML Treatment in Untreated Adult Patients

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