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LeukemiaPhase 3APL0406NCT00482833

Phase III Trial in Acute Promyelocytic Leukemia Patients

A Phase 3 study testing arsenic trioxide, idarubicin and mercaptopurine in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 110 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Open label, randomised, phase III multicenter trial. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Leukemia
What is being tested?
arsenic trioxide, idarubicin and mercaptopurine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
110 sitesin 3 countries
Study dates
Aug 2007to 17 Oct 2019
Phase
Phase 3
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent according to IGH/EU/GCP and national local laws
  • Newly diagnosed APL by cytomorphology, confirmed also by molecular analysis*.
  • Age ≤18 < 71 years
  • WHO performance status 0 -2 included
  • WBC at diagnosis ≤ 10 x 109/L
  • Serum total bilirubin ≤ 3.0 mg/dL (≤ 51µmol/L)
  • Serum creatinine ≤ 3.0 mg/dL (≤ 260 µmol/L)
  • The confirmation of diagnosis at genetic level (microspeckled PML nuclear distribution by PGM3 monoclonal antibody and/or PML/RARa fusion by RT-PCR and/or demonstration of t(15;17) by karyotyping) will be mandatory for patient eligibility. However, in order to avoid delay in treatment initiation, patients can be randomised on the basis of morphologic diagnosis only and before the results of genetic tests are available.

Who cannot join

  • Age < 18 and ≥ 71
  • WBC at diagnosis > 10 x 109/L
  • Other active malignancy at time of study entry
  • Lack of diagnostic confirmation at genetic level
  • Significant arrhythmias, EKG abnormalities (*see below) or neuropathy
  • Other cardiac contraindications for intensive chemotherapy (L-VEF <50%)
Show all 21Show fewer
  • Uncontrolled, life-threatening infections
  • Severe non-controlled pulmonary or cardiac disease
  • Women who are either pregnant or breast feeding, or of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they meet one of the following definitions:
  • Amenorrhea;
  • post surgical bilateral oophorectomy with or without hysterectomy;
  • using a highly effective method of birth control (defined as those which result in a failure rate less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives, IUDs, sexual abstinence or vasectomized partner.
  • Concomitant severe psychiatric disorder
  • HIV positivity
  • EKG abnormalities:
  • Congenital long QT syndrome;
  • History or presence of significant ventricular or atrial tachyarrhythmia
  • Clinically significant resting bradycardia (<50 beats per minute)
  • QTc > 450 msec on screening EKG (using the QTcF formula detailed on page 18)
  • Right bundle branch block plus left anterior hemiblock, bifascicular block
  • Use of other investigational drugs at the time of enrolment or within 30 days before study entry

Trial locations and contacts

110 sites in 3 countries.

110 sites in 3 countries

Italy56 sites

  • Ospedale Civile SS. Antonio e Biagio di Alessandria

    Alessandria

  • Ospedale Gen.le. Prov.le "C.G. Mazzoni"

    Ascoli Piceno

  • Az.Ospedaliera S.G.Moscati

    Avellino

  • Ematologia con trapianto- AOU Policlinico Consorziale di Bari

    Bari

  • Divisione di Ematologia - Ospedali Riuniti

    Bergamo

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

    Bologna

  • Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO

    Bolzano

  • Spedali Civili di Brescia

    Brescia

  • ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo

    Cagliari

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

    Catania

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

    Catanzaro

  • Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna

    Ferrara

  • Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"

    Genova

  • Divisione di Ematologia Ospedale "Santa Maria Goretti"

    Latina

  • ST. V. Fazzi

    Lecce

  • A.O. Universitaria Policlinico Martina di Messina

    Messina

  • Azienda ospedaliera Papardo

    Messina

  • IRCCS Fondazione Centro S. Raffaele del Monte Tabor

    Milan

  • Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia

    Milan

  • UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico

    Milan

  • Centro Oncologico Modenese - Dipartimento di Oncoematologia

    Modena

  • Azienda ospedaliera S. Gerardo di Monza

    Monza

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

    Naples

  • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

    Naples

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

    Naples

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

    Naples

  • ASL SA/1 di Nocera Inferiore

    Nocera Inferiore

  • A.O. Universitaria S. Luigi Gonzaga di Orbassano

    Orbassano

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

    Palermo

  • Ospedali Riuniti "Villa Sofia-Cervello"

    Palermo

  • Cattedra di Ematologia CTMO Università degli Studi di Parma

    Parma

  • IRCCS Policlinico S. Matteo di Pavia

    Pavia

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

    Perugia

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

    Pesaro

  • U.O. Ematologia Clinica - Azienda USL di Pescara

    Pescara

  • Ematologia - Ospedale San Carlo

    Potenza

  • Ospedale S. Maria delle Croci di Ravenna

    Ravenna

  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

    Reggio Calabria

  • IRCCS Centro di riferimento Oncologico di Basilicata

    Rionero in Vulture

  • Azienda Osp. S. Giovanni/Addolorata

    Roma

  • Divisione di Ematologia - Ospedale S. Camillo

    Roma

  • Ospedale S. Eugenio

    Roma

  • Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia

    Roma

  • Policlinico Campus Biomedico

    Roma

  • Policlinico Universitario Gemelli di Roma

    Roma

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

    Roma

  • Università degli Studi - Policlinico di Tor Vergata

    Roma

  • IRCCS Istituto Regina Elena

    Rome

  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

    Sassari

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

    Siena

  • SCDO Ematologia 2 AOU S.Giovanni Battista

    Torino

  • Clinica Ematologica - Policlinico Universitario

    Udine

  • Ospedale di circolo e Fondazione Macchi

    Varese

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

    Verona

  • ULSS N.6 Osp. S. Bortolo

    Vicenza

Other trials in Italy

Germany51 sites

  • Klinikum Bayreuth GmbH

    Bayreuth

  • Charité Campus Benjamin Franklin Berlin

    Berlin

  • Städt. Kliniken Bielefeld gem. GmbH

    Bielefeld

  • Universitätsklinikum Bonn

    Bonn

  • Ev. Diakonie-Krankenhaus gGmbH Bremen

    Bremen

  • Klinikum Bremen-Mitte gGmbH

    Bremen

  • Klinikum Chemnitz gGmbH

    Chemnitz

  • Universitätsklinikum C. G. Carus Dresden

    Dresden

  • Katholisches Klinikum Duisburg St. Johannes Hospital

    Duisburg

  • Universitätsklinikum Düsseldorf

    Düsseldorf

  • Uniklinikum Erlangen

    Erlangen

  • Kliniken Essen Süd, Ev. Krankenhaus Essen-Werden gGmbH

    Essen

  • Universitätsklinikum Essen

    Essen

  • Uniklinik Frankfurt/Main

    Frankfurt am Main

  • Städtische Kliniken Frankfurt a. M.-Höchst

    Frankfurt/a. M. -Höchst

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • Klinikum Fulda

    Fulda

  • Universitätsklinikum Gießen und Marburg Gießen

    Giessen

  • Universitätsklinikum Göttingen

    Göttingen

  • Asklepios Klinik Hamburg Altona

    Hamburg

  • Asklepios Klinik St. Georg Hamburg

    Hamburg

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg

  • St. Marien-Hospital gem. GmbH Hamm

    Hamm

  • Medizinische Hochschule Hannover

    Hanover

  • Universitätsklinikum Heidelberg

    Heidelberg

  • St. Bernward Krankenhaus Hildesheim

    Hildesheim

  • Universitätsklinikum des Saarlandes Homburg/Saar

    Homburg

  • Klinik für Knochenmarktransplantation und Hämatologie Idar-Oberstein

    Idar-Oberstein

  • Westpfalz-Klinikum GmbH Kaiserslautern

    Kaiserslautern

  • Caritas-Krankenhaus Lebach

    Lebach

  • Klinikum Lippe Lemgo

    Lippe

  • Uniklinikum Lübeck

    Lübeck

  • Klinikum der Johannes Gutenberg Universität Mainz

    Mainz

  • Universitätsklinikum Gießen und Marburg GmbH Marburg

    Marburg

  • Carl-von-Basedow-Klinikum Merseburg

    Merseburg

  • Johannes Wesling Klinikum Minden

    Minden

  • Klinikum rechts der Isar (München)

    München

  • Klinikum Nord Nürnberg

    Nuremberg

  • Klinikum Passau

    Passau

  • Universitätsklinikum Regensburg

    Regensburg

  • Caritas-Klinik St. Theresia Saarbrücken

    Saarbrücken

  • Diakonie-Krankenhaus Schwäbisch Hall

    Schwäbisch Hall

  • Diakonie-Klinikum Stuttgart

    Stuttgart

  • Klinikum Stuttgart Bürgerhospital

    Stuttgart

  • Robert Bosch Krankenhaus Stuttgart

    Stuttgart

  • Krankenanstalt Mutterhaus der Borromäerinnen Trier

    Trier

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier

  • Universitätsklinikum Tübingen

    Tübingen

  • Universitätsklinikum Ulm

    Ulm

  • Klinikum Villingen-Schwenningen

    Villingen-Schwenningen

  • HELIOS Klinikum Wuppertal

    Wuppertal

Other trials in Germany

Austria3 sites

  • Universitätsklinik Innsbruck Hämatologie Onkologie

    Innsbruck

  • Krankenhaus der Barmherzigen Schwestern Linz

    Linz

  • Universitätsklinik für Innere Medizin III Salzburg

    Salzburg

Other trials in Austria

About this study

Official title: A Randomised Phase III Study to Compare Arsenic Trioxide (ATO) Combined to ATRA Versus Standard ATRA and Anthracycline-Based Chemotherapy (AIDA Regimen) for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia

Open label, randomised, phase III multicenter trial.

Read the detailed description
  • Arm I:
  • Induction therapy: Patients receive oral tretinoin twice daily and arsenic trioxide IV over 2 hours on days 1-60. Patients achieving hematological complete remission go on to receive consolidation therapy.
  • Consolidation therapy: Patients receive oral tretinoin twice daily on days 1-14. Treatment with tretinoin repeats every 4 weeks for up to 7 courses. Patients also receive arsenic trioxide IV over 2 hours on days 1-5 in weeks 1-4. Treatment with arsenic trioxide repeats every 8 weeks for up to 4 courses.
  • Arm II:
  • Induction therapy: Patients receive tretinoin as in arm I induction therapy and idarubicin IV over 20 minutes on days 2, 4, 6, and 8. Patients achieving hematological complete remission go on to receive consolidation therapy.
  • Consolidation therapy: Patients receive oral tretinoin twice daily on days 1-45, idarubicin IV over 20 minutes on days 1-4 and day 31, and mitoxantrone hydrochloride IV over 30 minutes on days 16-20.

Marrow samples are collected after completion of consolidation therapy and analyzed by reverse transcriptase-PCR for molecular remission. Patients achieving molecular remission (PML-RARa negative) go on to receive maintenance therapy.

  • Maintenance therapy: Patients receive oral mercaptopurine once daily and methotrexate intramuscularly once weekly for 3 months. Treatment with mercaptopurine and methotrexate repeats every 3 months for 7 courses. After completion of course 1 of mercaptopurine and methotrexate, patients receive oral tretinoin once daily on days 1-15*. Treatment with tretinoin repeats every 3 months for 6 courses.

NOTE: *Patients do not receive mercaptopurine and methotrexate during tretinoin administration.

After completion of study therapy, patients are followed periodically for 5 years.

As of 14th September 2010, all patients needed to evaluate the primary endpoint (162 patients) have been recruited but the trial accrual continued in order to assess one secondary outcome (QoL)."

Conditions
Leukemia
Being tested
arsenic trioxide, idarubicin, mercaptopurine, methotrexate, all-trans retinoic acid
Keywords
adult acute promyelocytic leukemia (M3), adult acute myeloid leukemia with t(15;17)(q22;q12), untreated adult acute myeloid 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.

  • arsenic trioxideDrug

    Induction Arsenic Trioxide (As2O3=ATO), 0.15 mg/Kg IV over 2 hours daily starting on day 1. ATO will be continued until hematological CR or for a maximum of 60 days.

    Consolidation ATO, 0.15 mg/Kg IV over 2 hours daily for 5 days every week. Treatment will be continued for 4 weeks on and 4 weeks off, for a total of 4 cycles (last cycle administered on weeks 25 - 28).

  • idarubicinDrug

    Induction

    Idarubicin, 12 mg/m² on days 2, 4, 6 and 8 by short (20') intravenous infusion .

    If no hematological CR is achieved by 60 days after start of induction, patient will go off-study.

    Consolidation

    1st cycle Idarubicin, 5 mg/m2/day by short (20') intravenous infusion on days 1, 2, 3, 4.

    3rd cycle Idarubicin, 12 mg/m2/day as short (20') intravenous infusion only on day 1.

  • mercaptopurineDrug

    Maintenance therapy 6-Mercaptopurine (6-MP), 50 mg/m2/day orally. The dose will be adjusted according to hematopoietic toxicity during the follow-up period

  • methotrexateDrug

    Maintenance therapy Methotrexate (MTX), 15 mg/m2/weekly intramuscularly. The dose will be adjusted according to toxicity during the follow-up period.

  • all-trans retinoic acidDrug

    Induction ATRA, 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting on day 1. ATRA treatment will be continued until hematological CR and for a maximum of 60 days.

    Consolidation

    1. st cycle ATRA, 45 mg/m2/day, will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15.
    2. nd cycle ATRA, 45 mg/m2/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15.
    3. rd cycle ATRA, 45 mg/m2/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting from day 1 to day 15.

    Maintenance therapy

    ATRA, 45 mg/m2/day orally, for 15 days every three months until a two year period is completed.

  • all-trans retinoic acid (ATRA)Drug

    Induction All-trans retinoic acid (ATRA), 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment, starting on day 1. ATRA treatment will be continued until hematological complete remission (CR, see below for definition) or for a maximum of 60 days.

    Consolidation ATRA, 45 mg/m²/day will be administered orally in two equally divided doses and rounded to the nearest 10 mg increment. Treatment will be administered for 2 weeks on 2 weeks off and for a total of 7 cycles (last cycle administered on weeks 25 - 26).

Study groups in NCT00482833
Study groupRoleWhat they receive
ARM A - ATO/ATRAExperimentalNot described
Receives: Drug: arsenic trioxide; Drug: all-trans retinoic acid (ATRA)
ARM B - ATRAActive comparatorNot described
Receives: Drug: idarubicin; Drug: mercaptopurine; Drug: methotrexate; Drug: all-trans retinoic acid

What is being measured

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

  1. Event-free survival

    As of 14th september 2010, all patients needed to evaluate the primary endpoint have been recruited.

    Measured: At maximum 3.5 years from study entry

Secondary outcomes (10)

  1. Rate of hematological complete remission

    Measured: At maximum 60 days from induction therapy start

  2. Overall survival rate

    Measured: At 2 years from study entry

  3. Rate of cumulative incidence of relapse

    Measured: At 2 years from study entry

  4. Incidence of hematological and non-hematological toxicity episodes during treatment as assessed by CTC-NCI

    Measured: At maximum 60 days from induction therapy start and at maximum 225 days from consolidation therapy start

  5. Rate of molecular remission after 3rd consolidation course

    Measured: At maximum 225 days grom consolidation therapy start

  6. Assessment of acute promyelocytic leukemia/RARa transcript level reduction after induction and during consolidation therapy

    Measured: At maximum 60 days from induction therapy start and at maximum 225 days from consolidation therapy start

  7. Quality of life at the end of induction therapy and at the end of the 3rd consolidation course

    Measured: At maximum 60 days from induction therapy start and at maximum 225 days from consolidation therapy start

  8. Event free survival

    Measured: At 2 years from study entry

  9. Total hospitalization days during study therapy

    Measured: At maximum 3.5 years from study entry

  10. Event-free survival rate in the two arms

    Measured: At 2 years from study entry

Timeline

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

  1. First posted5 Jun 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionSep 2012
  4. Study completion17 Oct 2019

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00482833
Sponsor's protocol ID
APL0406
Other IDs
GIMEMA-SAL-APL0406, EUDRACT-2006-006188-22
Acronym
APL0406
Status last verified
Oct 2022
First submitted
4 Jun 2007
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No

Publications

  • Efficace F, Mandelli F, Avvisati G, Cottone F, Ferrara F, Di Bona E, Specchia G, Breccia M, Levis A, Sica S, Finizio O, Kropp MG, Fioritoni G, Cerqui E, Vignetti M, Amadori S, Schlenk RF, Platzbecker U, Lo-Coco F. Randomized phase III trial of retinoic acid and arsenic trioxide versus retinoic acid and chemotherapy in patients with acute promyelocytic leukemia: health-related quality-of-life outcomes. J Clin Oncol. 2014 Oct 20;32(30):3406-12. doi: 10.1200/JCO.2014.55.3453. Epub 2014 Sep 22.

    PubMed 25245446

  • Lo-Coco F, Avvisati G, Vignetti M, Thiede C, Orlando SM, Iacobelli S, Ferrara F, Fazi P, Cicconi L, Di Bona E, Specchia G, Sica S, Divona M, Levis A, Fiedler W, Cerqui E, Breccia M, Fioritoni G, Salih HR, Cazzola M, Melillo L, Carella AM, Brandts CH, Morra E, von Lilienfeld-Toal M, Hertenstein B, Wattad M, Lubbert M, Hanel M, Schmitz N, Link H, Kropp MG, Rambaldi A, La Nasa G, Luppi M, Ciceri F, Finizio O, Venditti A, Fabbiano F, Dohner K, Sauer M, Ganser A, Amadori S, Mandelli F, Dohner H, Ehninger G, Schlenk RF, Platzbecker U; Gruppo Italiano Malattie Ematologiche dell'Adulto; German-Austrian Acute Myeloid Leukemia Study Group; Study Alliance Leukemia. Retinoic acid and arsenic trioxide for acute promyelocytic leukemia. N Engl J Med. 2013 Jul 11;369(2):111-21. doi: 10.1056/NEJMoa1300874.

    PubMed 23841729

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing arsenic trioxide, idarubicin and mercaptopurine in people with Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 110 sites in 3 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 8 inclusion and 21 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 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in Italy, Germany, Austria. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

What does the primary outcome measure?

Event-free survival (time frame: At maximum 3.5 years from study entry). 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 NCT00482833, which also lists 2 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 12 Oct 2022.

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