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LeukemiaNCT01064557

"AIDA" Protocol (LAP 0493)

A study testing all-trans retinoic acid (ATRA) in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 80 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow… Read more about this study

Who is it for?
Ages 1 year to 75 years
Conditions the study is for
Leukemia
What is being tested?
all-trans retinoic acid (ATRA)
How many people
1,068 participants
Where
80 sitesin 5 countries
Study dates
Oct 1993to Dec 2020
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 1 year to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age > 12 months (1 year) and < 75 years
  • Morphological newly diagnosis of APL
  • Presence of the PML-RARa transcript
  • No cardiac contraindications to anthracycline chemotherapy
  • Serum creatinine <=2.5 mg/dL
  • Serum alkaline phosphatase <= 3 times the normal upper limit
Show all 10Show fewer
  • Serum bilirubin <= 3 times the normal upper limit
  • Serum SGOT <= 3 times the upper normal limit
  • Negative pregnancy test
  • Informed consent

Who cannot join

  • Age <= 12 months and >=75 years
  • absence of the PML-RARa transcript
  • Pregnant of lactating women
  • Presence of active serious infections that are not controlled by antibiotics
  • Prior treatment with antileukemic therapy (excluded corticosteroids)
  • Presence of severe concomitant psychiatric disease
Show all 15Show fewer
  • Presence of other concomitant malignant tumors, except basal cell carcinoma
  • Concurrent treatment with cytotoxic chemotherapy or radiotherapy
  • Cardiac contraindications to anthracycline chemotherapy
  • Serum creatinine >2.5 mg/dL
  • Serum alkaline phosphatase > 3 times the normal upper limit
  • Serum bilirubin > 3 times the normal upper limit
  • Serum SGOT > 3 times the upper normal limit
  • Positive pregnancy test
  • Absence of informed consent

Trial locations and contacts

80 sites in 5 countries.

Paola Fazi contact

p.fazi@gimema.it

Enrico Crea contact

e.crea@gimema.it

80 sites in 5 countries

Italy75 sites, 75 recruiting

  • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

    Alessandria

    Recruiting

  • Azienda Ospedaliera - Nuovo Ospedale "Torrette"

    Ancona

    Pietro Leoni, pleoni@univpm.it

    Recruiting

  • U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno

    Ascoli Piceno

    Piero Galieni, piero.galieni@sanita.marche.it

    Recruiting

  • Az.Ospedaliera S.G.Moscati

    Avellino

    Ettore Volpe, n.cantore@virgilio.it

    Recruiting

  • Centro di Riferimento Oncologico

    Aviano

    Recruiting

  • Unità Operativa Ematologia 1 - Università degli Studi di Bari

    Bari, 70010

    Vincenzo LISO, v.liso@ematba.uniba.it

    Recruiting

  • Ematologia con trapianto-Università degli Studi di Bari Aldo Moro

    Bari

    Recruiting

  • Azienda Ospedaliera - Papa Giovanni XXIII

    Bergamo

    Recruiting

  • ASL12 - Biella Ospedale degli Infermi - Dip. di Medicina e Geriatria - Struttura Complessa di Medicina Interna

    Biella

    Sandro Fontana, giovanni.bertinieri@asl12.piemonte.it

    Recruiting

  • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

    Bologna

    Recruiting

  • Comprensorio Sanitario di Bolzano - Azienda Sanitaria dell'Alto Adige - Ematologia e Centro TMO - Ospedale S.Maurizio

    Bolzano

    Recruiting

  • Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia

    Brescia

    Recruiting

  • Divisione di Ematologia Ospedale A. Perrino

    Brindisi

    Recruiting

  • ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

    Cagliari

    Recruiting

  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

    Catania

    Recruiting

  • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia

    Catanzaro

    Recruiting

  • Sezione di Ematologia C.T.M.O. Istituti Ospitalieri

    Cremona

    Recruiting

  • S.C. Ematologia ASO S. Croce e Carle

    Cuneo

    Recruiting

  • Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi

    Ferrara

    Recruiting

  • Policlinico di Careggi, Università delgi studi di Firenze

    Florence

    Pierluigi Rossi, a.bosi@dac.unifi.it

    Recruiting

  • Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria

    Foggia

    Recruiting

  • Ospedale S. Antonio Abate

    Gallarate

    Recruiting

  • Clinica Ematologica - DiMI - Università degli Studi di Genova

    Genova

    Recruiting

  • Clinica Medica III - Padiglione 3 - Azienda Ospedale Università San Martino

    Genova

    Recruiting

  • IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente

    Genova

    Recruiting

  • Ospedale San Martino

    Genova

    Recruiting

  • Università degli Studi

    Genova

    Recruiting

  • Divisione di Ematologia Ospedale "Santa Maria Goretti"

    Latina

    Luigi Deriu, emato@online.latina.it

    Recruiting

  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

    Lecce

    Nicola Di Renzo, direnzo.ematolecce@libero.it

    Recruiting

  • Divisione Ospedale Maggiore

    Lodi

    Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia

    Milan

    Recruiting

  • U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele

    Milan

    Recruiting

  • Centro Oncologico Modenese - Dipartimento di Oncoematologia

    Modena

    Recruiting

  • Azienda Ospedaliera "S.Gerardo"

    Monza

    Recruiting

  • A.S.L. Napoli 1 Ospedale San Giovanni Bosco

    Naples

    Renato De Biasi, ematoeumiranapoli@libero.it

    Recruiting

  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

    Naples

    Renato Cimino, felicettoferrara@katamail.com

    Recruiting

  • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

    Naples

    Bruno Rotoli, fabrizio.pane@unina.it

    Recruiting

  • Ospedale San Gennaro - ASL Napoli 1

    Naples

    Recruiting

  • Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE- 4° piano - Padiglione Palermo

    Naples

    Recruiting

  • Divisione di Oncologia Medica Ospedale Pierfortunato Calvi

    Noale

    Recruiting

  • Sez. di Ematologia Clinica Ospedale San Francesco

    Nuoro

    Attilio Gabbas, atgabbas@tiscali.it

    Recruiting

  • Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2

    Orbassano

    Recruiting

  • Ospedale Cervello

    Palermo, 90146

    Francesco FABBIANO, ffabbiano@libero.it

    Recruiting

  • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"

    Palermo

    A. Cajozzo, aidsabba@unipa.it

    Recruiting

  • La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello

    Palermo

    Recruiting

  • Ospedali Riuniti "Villa Sofia-Cervello"

    Palermo

    Francesco Caronia, fabbianofrancesco@tiscali.it

    Recruiting

  • Cattedra di Ematologia CTMO Università degli Studi di Parma

    Parma

    Recruiting

  • Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo

    Pavia

    Edoardo Ascari, c.balduini@smatteo.pv.it

    Recruiting

  • S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo

    Pavia

    Recruiting

  • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia

    Perugia

    Massimo Fabrizio Martelli, faliniem@unipg.it

    Recruiting

  • Sezione di Medicina Interna e Scienze e Oncologiche (MISO ) Osp. S.Maria della Misericordia

    Perugia

    Recruiting

  • Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore

    Pesaro

    Guido Lucarelli, g.visani@ospedalesansalvatore.it

    Recruiting

  • Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia

    Pisa

    Recruiting

  • Unità operativa Medicina II Az. Osp. S. M. degli Angeli

    Pordenone

    Recruiting

  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

    Reggio Emilia

    Recruiting

  • U.O. di Ematologia - Centro Oncologico Basilicata

    Rionero in Vulture

    Pellegrino Musto, p.musto@tin.it

    Recruiting

  • A.O Umberto I

    Roma

    Franco MANDELLI, MD, PhD, gimema@gimema.it

    Recruiting

  • Complesso Ospedaliero S. Giovanni Addolorata

    Roma

    Luciana Annino, luciana.annino@virgilio.it

    Recruiting

  • Divisione Ematologia - Università Campus Bio-Medico

    Roma

    Giuseppe Avvisati, g.avvisati@unicampus.it

    Recruiting

  • Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo

    Roma

    Recruiting

  • Pr. Lo Coco

    Roma

    Francesco Lo Coco, Pr, francesco.lo.coco@uniroma2.it

    Recruiting

  • U.O.C. Ematologia - Ospedale S.Eugenio

    Roma

    Recruiting

  • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

    Roma

    Recruiting

  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

    Roma

    Recruiting

  • Università degli Studi - Policlinico di Tor Vergata

    Roma

    Recruiting

  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

    S. G. Rotondo

    Recruiting

  • Dipartimento di Medicina Clinica e Sperimentale

    Sassari

    Recruiting

  • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"

    Siena

    Recruiting

  • Azienda Ospedaliera della Valtellina e della Valchiavenna

    Sondalo

    Recruiting

  • U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati

    Taranto

    Recruiting

  • Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista

    Torino

    Recruiting

  • Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"

    Torino

    Recruiting

  • Clinica Ematologica - Policlinico Universitario

    Udine

    Recruiting

  • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

    Verona

    Recruiting

  • ULSS N.6 Osp. S. Bortolo

    Vicenza

    Recruiting

Other trials in Italy

Netherlands2 sites, 2 recruiting

  • Department of Hematology - Medical Center - Leiden University

    Leiden

    Recruiting

  • Department of Hematology - St Radboud University - Hospital

    Nijmegen

    Recruiting

Other trials in Netherlands

Belgium1 site, 1 recruiting

  • Department of Hematology - Middelheim Ziekenhuis

    Antwerp

    Recruiting

Other trials in Belgium

Germany1 site, 1 recruiting

  • Department of Hematology - Klinikum Grosshadem - Ludwig Maxmilians

    München

    Recruiting

Other trials in Germany

Turkey (Türkiye)1 site, 1 recruiting

  • Department of Hematology - Ankara University School of Medicine - Ibni Sina Hospital

    Ankara

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Guideline for the Treatment of Newly Diagnosed Patients Eith Acutypromyelocytic Leukemia, Aged > 12 Months (1 Year) and <75 Years, Using All-trans Retinoic Acid in Combination With Idarubicin

The main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase.

Conditions
Leukemia
Being tested
all-trans retinoic acid (ATRA)
Keywords
Acute promyelocytic Leukemia
Medical subject headings
Leukemia, Leukemia, Promyelocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • all-trans retinoic acid (ATRA)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase.

Secondary outcomes (3)

  1. To assess the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase

  2. To evaluate the role of maintenance therapy with ATRA and chemotherapy in PCR positive patients at the end of the consolidation phase not eligible for a BMT procedure

  3. To assess the efficacy, in terms of CR rate, and toxicity of an induction treatment combining ATRA with Idarubicin

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2010 (estimated)
  2. Study startOct 1993
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,068 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01064557
Sponsor's protocol ID
AIDA0493
Status last verified
Oct 2020
First submitted
5 Feb 2010
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No

Publications

  • Avvisati G, Lo Coco F, Diverio D, Falda M, Ferrara F, Lazzarino M, Russo D, Petti MC, Mandelli F. AIDA (all-trans retinoic acid + idarubicin) in newly diagnosed acute promyelocytic leukemia: a Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) pilot study. Blood. 1996 Aug 15;88(4):1390-8.

    PubMed 8695858

  • Avvisati G, Lo-Coco F, Paoloni FP, Petti MC, Diverio D, Vignetti M, Latagliata R, Specchia G, Baccarani M, Di Bona E, Fioritoni G, Marmont F, Rambaldi A, Di Raimondo F, Kropp MG, Pizzolo G, Pogliani EM, Rossi G, Cantore N, Nobile F, Gabbas A, Ferrara F, Fazi P, Amadori S, Mandelli F; GIMEMA, AIEOP, and EORTC Cooperative Groups. AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance. Blood. 2011 May 5;117(18):4716-25. doi: 10.1182/blood-2010-08-302950. Epub 2011 Mar 8.

    PubMed 21385856

  • Latagliata R, Breccia M, Fazi P, Vignetti M, Di Raimondo F, Sborgia M, Vincelli D, Candoni A, Salvi F, Rupoli S, Martinelli G, Kropp MG, Tonso A, Venditti A, Melillo L, Cimino G, Petti MC, Avvisati G, Lo-Coco F, Mandelli F; GIMEMA Acute Leukaemia Working Party. GIMEMA AIDA 0493 amended protocol for elderly patients with acute promyelocytic leukaemia. Long-term results and prognostic factors. Br J Haematol. 2011 Sep;154(5):564-8. doi: 10.1111/j.1365-2141.2011.08593.x. Epub 2011 Jul 14.

    PubMed 21751984

Questions about this trial

What is this clinical trial studying?

A study testing all-trans retinoic acid (ATRA) in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 80 sites in 5 countries.

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 10 inclusion and 15 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in Italy, Netherlands, Belgium, Germany, Turkey (Türkiye). 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 Paola Fazi (p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase.. 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 NCT01064557, which also lists 3 linked publications.

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 14 Oct 2020.

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