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

22. desember 2009 oppdatert av: European Organisation for Research and Treatment of Cancer - EORTC

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

1520

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Antwerp, Belgia, 2020
        • Algemeen Ziekenhuis Middelheim
      • Brugge, Belgia, 8000
        • A.Z. St. Jan
      • Brussels, Belgia, 1070
        • Hopital Universitaire Erasme
      • Brussels (Bruxelles), Belgia, 1000
        • Institut Jules Bordet
      • Edegem, Belgia, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Liege, Belgia, B-4000
        • CHU Sart-Tilman
  • Frankrike
      • Lyon, Frankrike, 69437
        • Hôpital Edouard Herriot
      • Nice, Frankrike, 06189
        • Centre Antoine Lacassagne
      • Paris, Frankrike, 75674
        • Hôpital Cochin
      • Paris, Frankrike, 75743
        • Hopital Necker
      • Paris, Frankrike, 75181
        • Hotel Dieu de Paris
      • Suresnes, Frankrike, 92151
        • Centre Médico-Chirurgical Foch
      • Villejuif, Frankrike, F-94805
        • Institut Gustave Roussy
  • Italia
      • Alessandria, Italia, I-15100
        • Ospedale Civile Alessandria
      • Ancona, Italia, 60020
        • Ospedale Torrette University Ancona
      • Avellino, Italia
        • Ospedale Civile Avellino
      • Bari, Italia, 70124
        • Universita Degli Studi di Bari Policlinico
      • Brindisi, Italia, I-72100
        • Ospedale Regionale A. Di Summa
      • Cagliari, Italia, 09124
        • Ospedale Oncologico A. Businco
      • Catania, Italia, 95124
        • Ospedale Ferrarotto
      • Catanzaro, Italia, 88100
        • Ospedale Regionale A. Pugliese
      • Cremona, Italia, 26100
        • Centro Trapianti di Midollo Osseo
      • Cuneo, Italia, 12100
        • Ospedale Santa Croce
      • Firenze (Florence), Italia, 1 (50-134)
        • Universita Degli Studi di Firenze - Policlin. di Careggi
      • Foggia, Italia, 71100
        • Ospedali Riuniti Foggia
      • Gallarate Varese, Italia, 21013
        • Ospedale S. Antonio Abate
      • Genoa (Genova), Italia, 16132
        • Ospedale San Martino/Cliniche Universitarie Convenzionale
      • Latina, Italia, 04100
        • Ospedale Gen. Provinciale Santa Maria Goretti
      • Lodi, Italia, I-20075
        • Ospedale Maggiore Lodi
      • Milano (Milan), Italia, 20132
        • Instituto Scientifico H.S. Raffaele
      • Milano (Milan), Italia, 20162
        • Ospedale Maggiore Ca Granda
      • Modena, Italia, 41100
        • Università di Modena
      • Naples (Napoli), Italia, 80127
        • Azienda Ospedaliera "A. Cardarelli"
      • Naples (Napoli), Italia, 80131
        • Federico II University Medical School
      • Naples (Napoli), Italia, 80136
        • Ospedale S. Gennora USL 42
      • Naples (Napoli), Italia, 80144
        • Ospedale Nuovo Pellegrini
      • Novara, Italia, 28100
        • Ospedale Maggiore
      • Nuoro, Italia, 08100
        • Ospedale San Francesco
      • Orbassano, (Torino), Italia, 10043
        • Azienda Ospedale S. Luigi - Universita Di Torino
      • Palermo, Italia, 90146
        • Ospedale Cervello
      • Palermo, Italia, 90100
        • Policlinico - Cattedra di Ematologia
      • Palermo, Italia, 90127
        • Policlinico P. Giaccone - Universita Di Palermo
      • Parma, Italia, 43100
        • Azienda Ospedaliera di Parma
      • Pavia, Italia, 27100
        • University and I.R.C.C.S. Policlinico San Matteo
      • Perugia, Italia, 06122
        • Policlinico Monteluce
      • Pesaro, Italia, I-61100
        • Ospedale San Salvatore
      • Pescara, Italia, 65100
        • Ospedale Civile Pescara
      • Potenza, Italia, 85100
        • Ospedale San Carlo
      • Reggio Calabria, Italia, 89100
        • Ospedali Riuniti
      • Reggio Emilia, Italia, 42100
        • Arcispedale S. Maria Nuova
      • Rome, Italia, 00161
        • Azienda Policlinico Umberto Primo
      • Rome, Italia, 00168
        • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
      • Rome, Italia, 00144
        • Ospedale San Eugenio
      • San Giovanni - Rotondo, Italia, 71013
        • Ospedale Casa Sollievo della Sofferenza
      • Sassari, Italia, 07100
        • Istituto di Ematologia Universita - University di Sassari
      • Sondalo (so), Italia, 23037
        • Azienda Ospedaliera Ospedale E. Mortelli
      • Taranto, Italia, 74100
        • Ospedal SS Annunziata
      • Turin (Torino), Italia, 10126
        • Ospedale Molinette
  • Kroatia
      • Zagreb, Kroatia, 41000
        • University Hospital Rebro
      • Zagreb (Agram), Kroatia, 41000
        • Medical School/University of Zagreb
  • Nederland
      • 's-Hertogenbosch, Nederland, 5211 NL
        • Groot Ziekengasthuis 's-Hertogenbosch
      • Amsterdam, Nederland, 1091 HA
        • Onze Lieve Vrouwe Gasthuis
      • Enschede, Nederland, 7500 KA
        • Medisch Spectrum Twente
      • Leiden, Nederland, 2300 ZA
        • Leiden University Medical Center
      • Nijmegen, Nederland, NL-6252 HB
        • University Medical Center Nijmegen
      • Veldhoven, Nederland, 5500 MB DB
        • Sint Joseph Ziekenhuis
  • Portugal
      • Coimbra, Portugal, 3049
        • Hospitais da Universidade de Coimbra (HUC)
      • Porto, Portugal, 4200
        • Hospital Escolar San Joao
  • Tsjekkisk Republikk
      • Olomouc, Tsjekkisk Republikk, 775 20
        • University Hospital - Olomouc
      • Prague, Tsjekkisk Republikk, 128 20
        • Institute of Hematology and Blood Transfusion
  • Tyrkia
      • Ankara, Tyrkia, 06100
        • Ibn-i Sina Hospital, Ankara Univeristy
  • Tyskland
      • Duisburg, Tyskland, D-47055
        • Staedtische Kliniken Duisburg
      • Munich (Muenchen), Tyskland, D-81377
        • Klinikum Großhadern
  • Ungarn
      • Kecskemet, Ungarn, H-6000
        • County Hospital
  • Østerrike
      • Innsbruck, Østerrike, A-6020
        • Universitaetsklinik

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

15 år til 60 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Etterforskere

  • Studiestol: Robert A. Zittoun, MD, Hotel Dieu de Paris

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 1993

Datoer for studieregistrering

Først innsendt

1. november 1999

Først innsendt som oppfylte QC-kriteriene

16. juli 2004

Først lagt ut (Anslag)

19. juli 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. desember 2009

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. desember 2009

Sist bekreftet

1. desember 2009

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000063311
  • EORTC-06931

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Sponsorer og samarbeidspartnere

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Legemiddelintervensjoner

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Forhold

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