Leukemia, Myelocytic, AcuteLAM99PNCT00449319
AML Treatment in Untreated Adult Patients
A study testing Identification of appropriate therapies according to risks factors, Daunorubicine and Transplant in people with Leukemia, Myelocytic, Acute, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 36 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 61 years
- Conditions the study is for
- Leukemia, Myelocytic, Acute
- What is being tested?
- Identification of appropriate therapies according to risks factors, Daunorubicine and Transplant
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 36 sitesItaly
- Study dates
- Nov 1998to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 61 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- AML "de novo" with bone marrow blasts <=30%
- Performance status: 0-3
- FAB subtype: all except M3
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Italy36 sites, 36 recruiting
- Recruiting
Prof. Mozzana
Gallarate
- Recruiting
Dr. De Blasio
Latina
- Recruiting
Prof. Nalli
Lodi
- Recruiting
Prof. Bordigon
Milan
- Recruiting
Dr Miraglia
Naples
- Recruiting
Dr. Mettivier
Naples
- Recruiting
Dr.ssa Mastrullo
Naples
- Recruiting
Prof. Pane
Naples
- Recruiting
Prof. D'Arco
Nocera Inferiore
- Recruiting
Dr Avanzi
Novara
- Recruiting
Dr. Gabbas
Nuoro
- Recruiting
Prof. Saglio
Orbassano
- Recruiting
Dr Mirto
Palermo
- Recruiting
Prof. Citarrella
Palermo
- Recruiting
Prof. Mariani
Palermo
- Recruiting
Prof. Rizzoli
Parma
- Recruiting
Pr. Mecucci
Perugia
- Recruiting
Prof. Falini
Perugia
- Recruiting
Prof. Martelli
Perugia
- Recruiting
Dr. Fioritoni
Pescara
- Recruiting
Pr. Petrini
Pisa
- Recruiting
Dr. Ricciuti
Potenza
- Recruiting
Dr. Nobile
Reggio Calabria
- Recruiting
Dr. Andriani
Roma
- Recruiting
Dr. Majolino
Roma
- Recruiting
Pr. Amadori
Roma
- Recruiting
Pr. Annino
Roma
- Recruiting
Pr. Leone
Roma
- Recruiting
Pr. Lo Coco
Roma
- Recruiting
Dr. Santoro
Rozzano
- Recruiting
Pr. Carella
San Giovanni Rotondo
- Recruiting
Pr. Longinotti
Sassari
- Recruiting
Dr Epis
Sondalo
- Recruiting
Dr. Russo
Taormina
- Recruiting
Dr Mazza
Taranto
- Recruiting
Pr. Boccadoro
Torino
About this study
Official title: AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10
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.
Read the 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.
- Conditions
- Leukemia, Myelocytic, Acute
- Being tested
- Identification of appropriate therapies according to risks factors, Daunorubicine, Transplant
- 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.
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of appropriate therapies according to risks factorsProcedure or surgery
DaunorubicineDrug
TransplantProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startNov 1998
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myelocytic, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Investigators
- Franco MANDELLI, Pr., Principal investigator, Gruppo Italiano Malattie EMatologiche dell'Adulto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449319
- Sponsor's protocol ID
- LAM99P
- Acronym
- LAM99P
- Status last verified
- Nov 2017
- First submitted
- 19 Mar 2007
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AML Treatment in Untreated Adult Patients According to EORTC-GIMEMA Protocols AML8 and AML10
- ClinicalTrials.gov ID
- NCT00449319
- Acronym / sponsor ID
- LAM99P / LAM99P
- Conditions
- 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.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Nov 1998 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 20 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- AML "de novo" with bone marrow blasts <=30%
- Performance status: 0-3
- FAB subtype: all except M3
- Written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification of appropriate therapies according to risks factors | Procedure or surgery | – |
| Daunorubicine | Drug | – |
| Transplant | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco MANDELLI, Pr. principal investigator
Gruppo Italiano Malattie EMatologiche dell'Adulto
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identification of appropriate therapies according to risks factors, Daunorubicine and Transplant in people with Leukemia, Myelocytic, Acute, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 36 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco VIGNETTI, Dr (+39 06 441639831, m.vignetti@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.