Acute Myeloblastic LeukemiaNCT00390715
Treatment of Acute Myeloblastic Leukemia in Younger Patients
An observational study of Acute Myeloblastic Leukemia, run by PETHEMA Foundation at 42 sites in Spain.
Trial summary
study of the value of the cytogenetics and the monitoring of the residual minimum disease in the standard treatment of acute myeloblastic leukemia. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Acute Myeloblastic Leukemia
- What is being tested?
- chemotherapy
- How many people
- 600 participants
- Where
- 42 sitesSpain
- Study dates
- Jan 1999to Jan 2010
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: AML of new diagnose, no treated previously
Who may be able to join
- Age< or =65 years.
- ECOG<=3.
- AML of new diagnose.
- Consent for chemotherapy.
Who cannot join
None listed.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
Spain42 sites
Hospital Juan Canalejo
A Coruña, La Coruña
Hospital General de Alicante
Alicante, Alicante
Hospital Clínic
Barcelona, Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona
Hospital del Mar
Barcelona, Barcelona
Hospital Germans Trias i Pujol
Barcelona, Barcelona
Hospital vall d'Hebrón
Barcelona, Barcelona
Hospital Valle Hebrón-Materno Infantil
Barcelona, Barcelona
Complejo Hospitalario de Cáceres
Cáceres
Hospital Puerta del Mar
Cadiz, Cádiz
Hospital general de Castellón
Castelló, Castellón
Complejo Hospitalario Reina Sofía
Córdoba, Córdoba
Hospital Universitario Virgen de las Nieves
Granada, Granada
Hospital Virgen de las Nieves
Granada, Granada
Area Hospitalaria Juan Ramón Jimenez
Huelva
Hospital general de Jerez de la Frontera
Jerez de la Frontera
Hospital Virgen Blanca de León
León
Fundación Jiménez Díaz
Madrid, Madrid
Hospital Clínico San Carlos de Madrid
Madrid, Madrid
Hospital Doce de Octubre
Madrid, Madrid
Hospital General Universitario Gregorio Marañón, Madrid
Madrid, Madrid
Hospital Universitario de la Princesa
Madrid, Madrid
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Málaga
Xarxa assistencial de Manresa
Manresa, Barcelona
Hospital General Universitario Morales Meseguer.
Murcia, Murcia
Hospital Central de Asturias
Oviedo, Oviedo
Hospital Son Dureta
Palma de Mallorca, Palma de Mallorca
Clínica Universitaria de Navarra
Pamplona, Navarre
Hospital Clínico Universitario de Salamanca
Salamanca
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña
Hospital General de Segovia
Segovia
Hospital Universitario Virgen del Rocío
Seville, Sevilla
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Tarragona
Hospital Verge de la Cinta
Tortosa, Tarragona
Hospital Clínic
Valencia, Valencia
Hospital La Fe
Valencia, Valencia
Hospital Universitario Dr. Peset
Valencia, Valencia
Complejo Hospitalario Xeral-Cies
Vigo, Vigo
Hospital Txagorritxu
Vitoria-Gasteiz
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza
About this study
Official title: Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease
study of the value of the cytogenetics and the monitoring of the residual minimum disease in the standard treatment of acute myeloblastic leukemia.
Read the detailed description
The treatment scheme is purely welfare and therefore it does not require any approval of ethical committees for his application. It gathers the basic ideas of the present treatment of the AML, with optional induction according to preference of each center with daunorubicin or Idarubicin (x3) associated to AraC (x7). The patients who reach CR consolidate with an identical cycle to the used one in the induction. Later (if pte has identical donor HLA, and as much it as their doctors has preference by this option) receive allogenic transplant. The other patients who reach CR receive two intensifications, one that AraC to intermediate dose contains and another one with autologous transplant, previous preparation with Busulfán, Etoposide and AraC. Later all antileucemic treatment is suspended until possible relapse. This scheme of treatment is accompanied by a valuation of the quality of the CR with traditional morphology, Immunocytometry and molecular genetic study and of a pursuit of residual minimum disease (EMR) using the same techniques.
- Conditions
- Acute Myeloblastic Leukemia
- Being tested
- chemotherapy
- Keywords
- Acute Myeloblastic Leukemia
- 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.
chemotherapyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2006 (estimated)
- Study startJan 1999
- Primary completionDec 2007
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloblastic LeukemiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Diaz Mediavilla Joaquin, Dr, Study chair, Hospital Clínico Universitario San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390715
- Sponsor's protocol ID
- AML99<=65 años
- Status last verified
- Mar 2010
- First submitted
- 18 Oct 2006
- Last updated
- 15 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Value of the Cytogenetic and of the Monitoring of the Minimal Residual Disease
- ClinicalTrials.gov ID
- NCT00390715
- Acronym / sponsor ID
- AML99<=65 años
- Conditions
- Acute Myeloblastic Leukemia
- Keywords
- Acute Myeloblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Jan 1999
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Oct 2006 (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.
study of the value of the cytogenetics and the monitoring of the residual minimum disease in the standard treatment of acute myeloblastic leukemia.
Detailed description
The treatment scheme is purely welfare and therefore it does not require any approval of ethical committees for his application. It gathers the basic ideas of the present treatment of the AML, with optional induction according to preference of each center with daunorubicin or Idarubicin (x3) associated to AraC (x7). The patients who reach CR consolidate with an identical cycle to the used one in the induction. Later (if pte has identical donor HLA, and as much it as their doctors has preference by this option) receive allogenic transplant. The other patients who reach CR receive two intensifications, one that AraC to intermediate dose contains and another one with autologous transplant, previous preparation with Busulfán, Etoposide and AraC. Later all antileucemic treatment is suspended until possible relapse. This scheme of treatment is accompanied by a valuation of the quality of the CR with traditional morphology, Immunocytometry and molecular genetic study and of a pursuit of residual minimum disease (EMR) using the same techniques.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- AML of new diagnose, no treated previously
Key inclusion criteria (4 listed)
- Age< or =65 years.
- ECOG<=3.
- AML of new diagnose.
- Consent for chemotherapy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| chemotherapy | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2010.
- Spanish association of HaematologyLink provided by the sponsor.
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RecruitingPhase 2
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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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.
Diaz Mediavilla Joaquin, Dr study chair
Hospital Clínico Universitario San Carlos
42 sites 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, run by PETHEMA Foundation at 42 sites in Spain.
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 0 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: finished, as of the sponsor's last update on 15 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 15 Mar 2010.