"AIDA" Protocol (LAP 0493)

October 12, 2020 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1068

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • Recruiting
        • Department of Hematology - Middelheim Ziekenhuis
  • Germany
      • Munchen, Germany
        • Recruiting
        • Department of Hematology - Klinikum Grosshadem - Ludwig Maxmilians
  • Italy
      • Alessandria, Italy
        • Recruiting
        • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
      • Ancona, Italy
        • Recruiting
        • Azienda Ospedaliera - Nuovo Ospedale "Torrette"
        • Contact:
      • Ascoli, Italy
        • Recruiting
        • U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
        • Contact:
      • Avellino, Italy
      • Aviano, Italy
        • Recruiting
        • Centro di riferimento Oncologico
      • Bari, Italy, 70010
        • Recruiting
        • Unità Operativa Ematologia 1 - Università degli Studi di Bari
      • Bari, Italy
        • Recruiting
        • Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
      • Bergamo, Italy
        • Recruiting
        • Azienda Ospedaliera - Papa Giovanni XXIII
      • Biella, Italy
        • Recruiting
        • ASL12 - Biella Ospedale degli Infermi - Dip. di Medicina e Geriatria - Struttura Complessa di Medicina Interna
        • Contact:
      • Bologna, Italy
        • Recruiting
        • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
      • Bolzano, Italy
        • Recruiting
        • Comprensorio Sanitario di Bolzano - Azienda Sanitaria dell'Alto Adige - Ematologia e Centro TMO - Ospedale S.Maurizio
      • Brescia, Italy
        • Recruiting
        • Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
      • Brindisi, Italy
        • Recruiting
        • Divisione di Ematologia Ospedale A. Perrino
      • Cagliari, Italy
        • Recruiting
        • ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
      • Catania, Italy
        • Recruiting
        • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
      • Catanzaro, Italy
        • Recruiting
        • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
      • Cremona, Italy
        • Recruiting
        • Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
      • Cuneo, Italy
        • Recruiting
        • S.C. Ematologia ASO S. Croce e Carle
      • Ferrara, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
      • Firenze, Italy
        • Recruiting
        • Policlinico di Careggi, Università delgi studi di Firenze
        • Contact:
      • Foggia, Italy
        • Recruiting
        • Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
      • Gallarate, Italy
        • Recruiting
        • Ospedale S. Antonio Abate
      • Genova, Italy
        • Recruiting
        • Ospedale San Martino
      • Genova, Italy
        • Recruiting
        • Clinica Ematologica - DiMI - Università degli Studi di Genova
      • Genova, Italy
        • Recruiting
        • Clinica Medica III - Padiglione 3 - Azienda Ospedale Università San Martino
      • Genova, Italy
        • Recruiting
        • IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
      • Genova, Italy
        • Recruiting
        • Università degli Studi
      • Latina, Italy
        • Recruiting
        • Divisione di Ematologia Ospedale "Santa Maria Goretti"
        • Contact:
      • Lecce, Italy
      • Lodi, Italy
        • Recruiting
        • Divisione Ospedale Maggiore
      • Milano, Italy
        • Recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia
      • Milano, Italy
        • Recruiting
        • U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
      • Modena, Italy
        • Recruiting
        • Centro Oncologico Modenese - Dipartimento di Oncoematologia
      • Monza, Italy
        • Recruiting
        • Azienda Ospedaliera "S.Gerardo"
      • Napoli, Italy
      • Napoli, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
        • Contact:
      • Napoli, Italy
        • Recruiting
        • Ospedale San Gennaro - ASL Napoli 1
      • Napoli, Italy
      • Napoli, Italy
        • Recruiting
        • Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE- 4° piano - Padiglione Palermo
      • Noale, Italy
        • Recruiting
        • Divisione di Oncologia Medica Ospedale Pierfortunato Calvi
      • Nuoro, Italy
        • Recruiting
        • Sez. di Ematologia Clinica Ospedale San Francesco
        • Contact:
      • Orbassano, Italy
        • Recruiting
        • Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
      • Palermo, Italy
      • Palermo, Italy
        • Recruiting
        • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
        • Contact:
      • Palermo, Italy, 90146
      • Palermo, Italy
        • Recruiting
        • La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello
      • Parma, Italy
        • Recruiting
        • Cattedra di Ematologia CTMO Università degli Studi di Parma
      • Pavia, Italy
        • Recruiting
        • Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo
        • Contact:
      • Pavia, Italy
        • Recruiting
        • S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
      • Perugia, Italy
        • Recruiting
        • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
        • Contact:
      • Perugia, Italy
        • Recruiting
        • Sezione di Medicina Interna e Scienze e Oncologiche (MISO ) Osp. S.Maria della Misericordia
      • Pesaro, Italy
      • Pisa, Italy
        • Recruiting
        • Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
      • Pordenone, Italy
        • Recruiting
        • Unità operativa Medicina II Az. Osp. S. M. degli Angeli
      • Reggio Emilia, Italy
        • Recruiting
        • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
      • Rionero in Vulture, Italy
        • Recruiting
        • U.O. di Ematologia - Centro Oncologico Basilicata
        • Contact:
      • Roma, Italy
        • Recruiting
        • Divisione Ematologia - Università Campus Bio-Medico
      • Roma, Italy
        • Recruiting
        • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
      • Roma, Italy
        • Recruiting
        • Università degli Studi - Policlinico di Tor Vergata
      • Roma, Italy
      • Roma, Italy
        • Recruiting
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • Roma, Italy
        • Recruiting
        • Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo
      • Roma, Italy
        • Recruiting
        • U.O.C. Ematologia - Ospedale S.Eugenio
      • Roma, Italy
        • Recruiting
        • A.O Umberto I
      • Roma, Italy
      • S. G. Rotondo, Italy
        • Recruiting
        • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
      • Sassari, Italy
        • Recruiting
        • Dipartimento di Medicina Clinica e Sperimentale
      • Siena, Italy
        • Recruiting
        • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
      • Sondalo, Italy
        • Recruiting
        • Azienda Ospedaliera della Valtellina e della Valchiavenna
      • Taranto, Italy
        • Recruiting
        • U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati
      • Torino, Italy
        • Recruiting
        • Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
      • Torino, Italy
        • Recruiting
        • Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
      • Udine, Italy
        • Recruiting
        • Clinica Ematologica - Policlinico Universitario
      • Verona, Italy
        • Recruiting
        • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
      • Vicenza, Italy
        • Recruiting
        • ULSS N.6 Osp. S. Bortolo
  • Netherlands
      • Leiden, Netherlands
        • Recruiting
        • Department of Hematology - Medical Center - Leiden University
      • Nijmegen, Netherlands
        • Recruiting
        • Department of Hematology - St Radboud University - Hospital
  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Department of Hematology - Ankara University School of Medicine - Ibni Sina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Serum bilirubin <= 3 times the normal upper limit
  • Serum SGOT <= 3 times the upper normal limit
  • Negative pregnancy test
  • Informed consent

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
To assess the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase
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
To assess the efficacy, in terms of CR rate, and toxicity of an induction treatment combining ATRA with Idarubicin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1993

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (Estimate)

February 8, 2010

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIDA0493

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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