Acute Myeloblastic LeukemiaALFA1200NCT01966497
Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia
An observational study of Acute Myeloblastic Leukemia and Aged Higher Than 60 Years Old, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of this observational survey is to estimate the incidence, the typology, and the evolution of patients with acute myelobalstic leukemia, aged more than 60 years old. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloblastic Leukemia, Aged Higher Than 60 Years Old
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Nov 2019
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospital admissions from the participating centres
Who may be able to join
- Aged 60 years or more
- With a morphologically proven diagnosis of AML according to WHO 2008 classification
- Not previously treated for AML
- Signed informed consent.
Who cannot join
- APL in the WHO classification.
- Ph1-positive AML or prior Ph1-positive disease
- AML evolving from a prior MPN in the WHO 2008 classification.
- Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
- ECOG Performance Status Score > 3
- Positive serology for HIV or HTLV1, or active viralinfection for HBV and HBC.
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- Severe uncontrolled infection at inclusion time.
- Psychiatric disease or an history of non-complianceto medical regimens or patients considered potentially unreliable.
- Absence of Health Care Insurance
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Avicenne
Bobigny, Île-de-France Region, 93
Claude Gardin, MD, claude.gardin@avc.aphp.fr
About this study
Official title: Observational Study of Patients Older Than 60 Years and With Acute Myeloblastic Leukemia Who Are Administered Standard Chemotherapy Based on Idarubicine-cytarabine
The main objective of this observational survey is to estimate the incidence, the typology, and the evolution of patients with acute myelobalstic leukemia, aged more than 60 years old. In this age group (aged more than 60y), three groups of patients with very different response rates and late outcome can be delineated with specific standard chemotherapy.
- Keywords
- AML
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Core study therapy | * idarubicin for both induction and consolidation courses * if Cr, two cycles of IDAC alone (1.5g/m2 per infusion every 12hours, on D1, 3 and 5 of each cycle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence of failures
failures include
- resistant disease defined according to the IWG AML response criteria
- hypoplastic marrow after D42 and absence of myeloidrecovery
- early relapse up to 9 months from CR : Either AML relapse as in the IWG classification or MDS relapse
Measured: 9 months
Secondary outcomes (4)
response rate
Measured: 9 months
relapse rate
Either AML relapse as in the IWG classification
- Or MDS relapse defined for this study as follows: (i) Persistent cytopenias, if unexplained by other cause, and (ii) myelodysplastic marrow with less than 20% marrow blasts in two samples taken 3 months apart
Measured: within 2 years after inclusion
overall survival
Measured: within 2 years after inclusion
adverse events
Measured: within 2 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966497
- Sponsor's protocol ID
- NI11020
- Acronym
- ALFA1200
- Status last verified
- Nov 2017
- First submitted
- 17 Oct 2013
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gardin C, Pautas C, Fournier E, Itzykson R, Lemasle E, Bourhis JH, Ades L, Marolleau JP, Malfuson JV, Gastaud L, Raffoux E, Lambert J, Braun T, Thomas X, Chantepie S, Cluzeau T, de Botton S, Berthon C, Boissel N, Duployez N, Terre C, Peffault de Latour R, Michallet M, Celli-Lebras K, Preudhomme C, Dombret H. Added prognostic value of secondary AML-like gene mutations in ELN intermediate-risk older AML: ALFA-1200 study results. Blood Adv. 2020 May 12;4(9):1942-1949. doi: 10.1182/bloodadvances.2019001349.
PubMed 32380535
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Patients Older Than 60 Years and With Acute Myeloblastic Leukemia Who Are Administered Standard Chemotherapy Based on Idarubicine-cytarabine
- ClinicalTrials.gov ID
- NCT01966497
- Acronym / sponsor ID
- ALFA1200 / NI11020
- Keywords
- AML
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 21 Oct 2013 (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 main objective of this observational survey is to estimate the incidence, the typology, and the evolution of patients with acute myelobalstic leukemia, aged more than 60 years old. In this age group (aged more than 60y), three groups of patients with very different response rates and late outcome can be delineated with specific standard chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Core study therapy | – | –* idarubicin for both induction and consolidation courses * if Cr, two cycles of IDAC alone (1.5g/m2 per infusion every 12hours, on D1, 3 and 5 of each cycle) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital admissions from the participating centres
Key inclusion criteria (4 listed)
- Aged 60 years or more
- With a morphologically proven diagnosis of AML according to WHO 2008 classification
- Not previously treated for AML
- Signed informed consent.
Key exclusion criteria (9 listed)
- APL in the WHO classification.
- Ph1-positive AML or prior Ph1-positive disease
- AML evolving from a prior MPN in the WHO 2008 classification.
- Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
- ECOG Performance Status Score > 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cumulative incidence of failures
Time frame: 9 months
failures include * resistant disease defined according to the IWG AML response criteria * hypoplastic marrow after D42 and absence of myeloidrecovery * early relapse up to 9 months from CR : Either AML relapse as in the IWG classification or MDS relapse
4 secondary outcomes
response rate
Time frame: 9 months
relapse rate
Time frame: within 2 years after inclusion
overall survival
Time frame: within 2 years after inclusion
adverse events
Time frame: within 2 years after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Derived from this study: PubMed 32380535Gardin C, Pautas C, Fournier E, Itzykson R, Lemasle E, Bourhis JH, Ades L, Marolleau JP, Malfuson JV, Gastaud L, Raffoux E, Lambert J, Braun T, Thomas X, Chantepie S, Cluzeau T, de Botton S, Berthon C, Boissel N, Duployez N, Terre C, Peffault de Latour R, Michallet M, Celli-Lebras K, Preudhomme C, Dombret H. Added prognostic value of secondary AML-like gene mutations in ELN intermediate-risk older AML: ALFA-1200 study results. Blood Adv. 2020 May 12;4(9):1942-1949. doi: 10.1182/bloodadvances.2019001349.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloblastic Leukemia and Aged Higher Than 60 Years Old, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 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 20 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 1 site in France. 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 Hervé Dombret, MD PhD (33 1 4249 49 49, herve.dombret@sls.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative incidence of failures (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01966497, which also lists 1 linked publication.
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 20 Nov 2017.