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LeukemiaPhase 3NCT00002549

Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Acute Myelogenous Leukemia

A Phase 3 study testing filgrastim, busulfan and cyclophosphamide in people with Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC at 75 sites in 11 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Read more about this study

Who is it for?
Ages 15 to 60 years
Conditions the study is for
Leukemia
What is being tested?
filgrastim, busulfan and cyclophosphamide
Type of treatment
Surgery or procedure
How many people
1,520 participants
Where
75 sitesin 11 countries
Study dates
Nov 1993to not given
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 15 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS: Newly diagnosed acute myeloid leukemia (AML) of any FAB histology (M1-M7) except M3 At least 30% blast cells in bone marrow smears Secondary leukemias eligible, as follows: Following cured malignancies, including Hodgkin's disease Following exposure to alkylating agents or radiotherapy for other reasons The following leukemias are excluded: Blast crisis of chronic myeloid leukemia Leukemia secondary to other myeloproliferative disease Leukemia secondary to myelodysplastic syndrome of more than 6 months' duration No other progressive malignant disease

PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: Not specified Hematopoietic: Not applicable Hepatic: Bilirubin no greater than 1.5 x ULN Renal: Creatinine no greater than 1.5 x ULN Cardiovascular: No severe heart failure requiring diuretics or with an LVEF less than 50% Other: No severe concomitant neurologic disease No severe concomitant psychologic disease

PRIOR CONCURRENT THERAPY: No prior therapy for AML (chemotherapy, radiotherapy, or more than 7 days of corticosteroids)

Trial locations and contacts

75 sites in 11 countries.

75 sites in 11 countries

Italy45 sites

  • Ospedale Civile Alessandria

    Alessandria, I-15100

  • Ospedale Torrette University Ancona

    Ancona, 60020

  • Ospedale Civile Avellino

    Avellino

  • Universita Degli Studi di Bari Policlinico

    Bari, 70124

  • Ospedale Regionale A. Di Summa

    Brindisi, I-72100

  • Ospedale Oncologico A. Businco

    Cagliari, 09124

  • Ospedale Ferrarotto

    Catania, 95124

  • Ospedale Regionale A. Pugliese

    Catanzaro, 88100

  • Centro Trapianti di Midollo Osseo

    Cremona, 26100

  • Ospedale Santa Croce

    Cuneo, 12100

  • Universita Degli Studi di Firenze - Policlin. di Careggi

    Firenze (Florence), 1 (50-134)

  • Ospedali Riuniti Foggia

    Foggia, 71100

  • Ospedale S. Antonio Abate

    Gallarate Varese, 21013

  • Ospedale San Martino/Cliniche Universitarie Convenzionale

    Genoa (Genova), 16132

  • Ospedale Gen. Provinciale Santa Maria Goretti

    Latina, 04100

  • Ospedale Maggiore Lodi

    Lodi, I-20075

  • Instituto Scientifico H.S. Raffaele

    Milano (Milan), 20132

  • Ospedale Maggiore Ca Granda

    Milano (Milan), 20162

  • Universita di Modena

    Modena, 41100

  • Azienda Ospedaliera "A. Cardarelli"

    Naples (Napoli), 80127

  • Federico II University Medical School

    Naples (Napoli), 80131

  • Ospedale S. Gennora USL 42

    Naples (Napoli), 80136

  • Ospedale Nuovo Pellegrini

    Naples (Napoli), 80144

  • Ospedale Maggiore

    Novara, 28100

  • Ospedale San Francesco

    Nuoro, 08100

  • Azienda Ospedale S. Luigi - Universita Di Torino

    Orbassano, (Torino), 10043

  • Policlinico - Cattedra di Ematologia

    Palermo, 90100

  • Policlinico P. Giaccone - Universita Di Palermo

    Palermo, 90127

  • Ospedale Cervello

    Palermo, 90146

  • Azienda Ospedaliera Di Parma

    Parma, 43100

  • University and I.R.C.C.S. Policlinico San Matteo

    Pavia, 27100

  • Policlinico Monteluce

    Perugia, 06122

  • Ospedale San Salvatore

    Pesaro, I-61100

  • Ospedale Civile Pescara

    Pescara, 65100

  • Ospedale San Carlo

    Potenza, 85100

  • Ospedali Riuniti

    Reggio Calabria, 89100

  • Arcispedale S. Maria Nuova

    Reggio Emilia, 42100

  • Ospedale San Eugenio

    Rome, 00144

  • Azienda Policlinico Umberto Primo

    Rome, 00161

  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

    Rome, 00168

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • Istituto di Ematologia Universita - University di Sassari

    Sassari, 07100

  • Azienda Ospedaliera Ospedale E. Mortelli

    Sondalo (so), 23037

  • Ospedal SS Annunziata

    Taranto, 74100

  • Ospedale Molinette

    Turin (Torino), 10126

Other trials in Italy

France7 sites

  • Hopital Edouard Herriot

    Lyon, 69437

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hotel Dieu de Paris

    Paris, 75181

  • Hopital Cochin

    Paris, 75674

  • Hopital Necker

    Paris, 75743

  • Centre Medico-Chirurgical Foch

    Suresnes, 92151

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Belgium6 sites

  • Algemeen Ziekenhuis Middelheim

    Antwerp, 2020

  • A.Z. St. Jan

    Bruges, 8000

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Institut Jules Bordet

    Brussels (Bruxelles), 1000

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • CHU Sart-Tilman

    Liège, B-4000

Other trials in Belgium

Netherlands6 sites

  • Groot Ziekengasthuis 's-Hertogenbosch

    's-Hertogenbosch, 5211 NL

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • Leiden University Medical Center

    Leiden, 2300 ZA

  • University Medical Center Nijmegen

    Nijmegen, NL-6252 HB

  • Sint Joseph Ziekenhuis

    Veldhoven, 5500 MB DB

Other trials in Netherlands

Croatia2 sites

  • University Hospital Rebro

    Zagreb, 41000

  • Medical School/University of Zagreb

    Zagreb (Agram), 41000

Other trials in Croatia

Czechia2 sites

  • University Hospital - Olomouc

    Olomouc, 775 20

  • Institute of Hematology and Blood Transfusion

    Prague, 128 20

Other trials in Czechia

Germany2 sites

  • Staedtische Kliniken Duisburg

    Duisburg, D-47055

  • Klinikum Grosshadern

    Munich (Muenchen), D-81377

Other trials in Germany

Portugal2 sites

  • Hospitais da Universidade de Coimbra (HUC)

    Coimbra, 3049

  • Hospital Escolar San Joao

    Porto, 4200

Other trials in Portugal

Austria1 site

  • Universitaetsklinik

    Innsbruck, A-6020

Other trials in Austria

Hungary1 site

  • County Hospital

    Kecskemét, H-6000

Other trials in Hungary

Turkey (Türkiye)1 site

  • Ibn-i Sina Hospital, Ankara Univeristy

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: RANDOMIZED PHASE III STUDY OF INDUCTION (ICE VS MICE VS DCE) AND INTENSIVE CONSOLIDATION (IDIA VS NOVIA VS DIA) FOLLOWED BY BONE MARROW TRANSPLANTATION IN ACUTE MYELOGENOUS LEUKEMIA: AML 10 PROTOCOL

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with acute myelogenous leukemia.

Read the detailed description

OBJECTIVES: I. Determine the complete remission (CR) rate following 1 or 2 courses of ICE (idarubicin/cytarabine/etoposide) vs. MICE (mitoxantrone/cytarabine/etoposide) vs. DCE (daunorubicin/cytarabine/etoposide) in patients with newly diagnosed acute myeloid leukemia. II. Compare disease-free survival and overall survival achieved with each anthracycline on the above induction regimens and with intermediate-dose cytarabine (IDIA vs. NOVIA vs. DIA) as consolidation therapy. III. Compare disease-free survival, relapse rate, death in first CR, and overall survival in patients who receive peripheral blood stem cells (PBSC) vs. autologous bone marrow transplant (AuBMT) vs. allogeneic bone marrow transplant (AlBMT) as rescue from myeloablative therapy following remission consolidation. IV. Assess the time to recovery of normal or acceptable polymorphonuclear leukocyte and platelet counts following each treatment step. V. Determine the incidence and type of grade 4 toxicity and treatment-related mortality. VI. Evaluate the quality of life during each step of treatment using self-administered questionnaires. VII. Compare stem cell mobilization after IDIA vs. NOVIA vs. DIA, each using granulocyte colony-stimulating factor as the mobilizing growth factor. VIII. Assess the rate of completion of stem cell transplantation using PBSC vs. AlBMT vs. AuBMT as the last step of therapy. IX. Compare the costs of treatment (e.g., antibiotics and transfusion requirements) and hospitalization duration between the AuBMT vs. PBSC.

OUTLINE: Randomized study. All patients are randomized to Arms I, II, and III for Induction/Consolidation. Patients in CR following Consolidation who have an HLA-identical sibling, are less than 45 or 55 years of age (depending on center policy), and have adequate organ function are nonrandomly assigned to AlBMT on Regimen A; those in CR who are without an available sibling donor and who have adequate organ function proceed to Regimen B, then are randomized to Arms IV and V. The following acronyms are used: AlBMT Allogeneic Bone Marrow Transplant ARA-C Cytarabine, NSC-63878 AuBMT Autologous Bone Marrow Transplant BU Busulfan, NSC-750 CTX Cyclophosphamide, NSC-26271 DCE DNR/ARA-C/VP-16 DHAD Mitoxantrone, NSC-301739 DIA DNR/ID ARA-C DNR Daunorubicin, NSC-82151 G-CSF Granulocyte Colony-Stimulating Factor (Rhone-Poulenc-Rorer) ICE IDA/ARA-C/VP-16 IDA Idarubicin, NSC-256439 ID Intermediate Dose IDIA IDA/ID ARA-C Mesna Mercaptoethane sulfonate, NSC-113891 MICE DHAD/ARA-C/VP-16 NOVIA DHAD/ID ARA-C PBSC Peripheral Blood Stem Cells TBI Total-Body Irradiation VP-16 Etoposide, NSC-141540 INDUCTION/CONSOLIDATION: Arm I: 3-Drug Combination Chemotherapy followed by 2-Drug Combination Chemotherapy. ICE; followed by IDIA. Arm II: 3-Drug Combination Chemotherapy followed by 2-Drug Combination Chemotherapy. MICE; followed by NOVIA. Arm III: 3-Drug Combination Chemotherapy followed by 2-Drug Combination Chemotherapy. DCE; followed by DIA. POSTCONSOLIDATION THERAPY: Regimen A: Single-Agent Chemoablation plus Radioablation or 2-Drug Chemoablation followed by Hematopoietic Rescue. CTX; plus TBI (equipment unspecified); or CTX/BU; followed by AlBMT. Entry on EORTC study comparing CI IDA with standard CTX/TBI or CTX/BU encouraged. Regimen B: Stem cell Mobilization and Harvest. G-CSF or CTX/G-CSF. Arm IV: Single-Agent Chemoablation plus Radioablation or 2-Drug Chemoablation followed by Hematopoietic Rescue. CTX/TBI or CTX/BU; followed by PBSC. Arm V: Single-Agent Chemoablation plus Radioablation or 2-Drug Chemoablation followed by Hematopoietic Rescue. CTX/TBI or CTX/BU; followed by AuBMT.

PROJECTED ACCRUAL: 1,520 patients will be randomized for Induction/Consolidation over about 5 years; if excessive deaths are found at interim analyses, the inferior arm will close. It is expected that 744 patients will be randomized for Postconsolidation therapy, with 345 patients followed until relapse/death.

Conditions
Leukemia
Being tested
filgrastim, busulfan, cyclophosphamide, cytarabine, daunorubicin hydrochloride
Keywords
untreated adult acute myeloid leukemia, adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute megakaryoblastic leukemia (M7), secondary acute myeloid leukemia, adult acute monocytic leukemia (M5b)
Medical subject headings
Leukemia, Leukemia, Erythroblastic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute, Leukemia, Megakaryoblastic, Acute

What participants receive

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

Timeline

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

  1. First posted19 Jul 2004 (estimated)
  2. Study startNov 1993

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
Enrolment
1,520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002549
Sponsor's protocol ID
CDR0000063311
Other IDs
EORTC-06931
Status last verified
Dec 2009
First submitted
1 Nov 1999
Last updated
23 Dec 2009
Results posted
No

Publications

  • Maurillo L, Buccisano F, Spagnoli A, et al.: In acute myeloid leukemia, the use in induction of standard dose arac is associated with a better quality of response as compared to an induction regimen containing high dose arac. [Abstract] Blood 114 (22): A-1584, 2009.

  • Oosterveld, M, Suciu S, Muus P, et al.: A new prognostic disease specific model to predict survival after intensive antileukemic treatment for young patients with poor-risk MDS and AML: results of the CRIANT and AML-10 studies conducted by the EORTC/GIMEMA/SAKK/HOVON/EBMT groups. [Abstract] Blood 104 (11): A-2020, 2004.

  • Mandelli F, Vignetti M, Suciu S, Stasi R, Petti MC, Meloni G, Muus P, Marmont F, Marie JP, Labar B, Thomas X, Di Raimondo F, Willemze R, Liso V, Ferrara F, Baila L, Fazi P, Zittoun R, Amadori S, de Witte T. Daunorubicin versus mitoxantrone versus idarubicin as induction and consolidation chemotherapy for adults with acute myeloid leukemia: the EORTC and GIMEMA Groups Study AML-10. J Clin Oncol. 2009 Nov 10;27(32):5397-403. doi: 10.1200/JCO.2008.20.6490. Epub 2009 Oct 13.

    PubMed 19826132

  • Baron F, Stevens-Kroef M, Kicinski M, Meloni G, Muus P, Marie JP, Halkes CJM, Thomas X, Vrhovac R, Albano F, Lefrere F Sr, Sica S, Mancini M, Venditti A, Hagemeijer A, Jansen JH, Amadori S, de Witte T, Willemze R, Suciu S. Impact of induction regimen and allogeneic hematopoietic cell transplantation on outcome in younger adults with acute myeloid leukemia with a monosomal karyotype. Haematologica. 2019 Jun;104(6):1168-1175. doi: 10.3324/haematol.2018.204826. Epub 2018 Dec 6.

    PubMed 30523055

  • Baron F, Stevens-Kroef M, Kicinski M, Meloni G, Muus P, Marie JP, Halkes CJM, Thomas X, Vrhovac R, Specchia G, Lefrere F Sr, Sica S, Mancini M, Venditti A, Hagemeijer A, Becker H, Jansen JH, Amadori S, de Witte T, Willemze R, Suciu S. Cytogenetic clonal heterogeneity is not an independent prognosis factor in 15-60-year-old AML patients: results on 1291 patients included in the EORTC/GIMEMA AML-10 and AML-12 trials. Ann Hematol. 2018 Oct;97(10):1785-1795. doi: 10.1007/s00277-018-3396-4. Epub 2018 Jun 20.

    PubMed 29926156

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, busulfan and cyclophosphamide in people with Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC at 75 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Italy, France, Belgium, Netherlands, Croatia and 6 more countries. 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?

Results are not available in the source record.

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?

On the ClinicalTrials.gov record for NCT00002549, which also lists 5 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 23 Dec 2009.

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Clinical Trial NCT00002549 | AzTrials