- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00002549
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Acute Myelogenous Leukemia
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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's-Hertogenbosch, 네덜란드, 5211 NL
- Groot Ziekengasthuis 's-Hertogenbosch
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Amsterdam, 네덜란드, 1091 HA
- Onze Lieve Vrouwe Gasthuis
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Enschede, 네덜란드, 7500 KA
- Medisch Spectrum Twente
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Leiden, 네덜란드, 2300 ZA
- Leiden University Medical Center
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Nijmegen, 네덜란드, NL-6252 HB
- University Medical Center Nijmegen
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Veldhoven, 네덜란드, 5500 MB DB
- Sint Joseph Ziekenhuis
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Duisburg, 독일, D-47055
- Staedtische Kliniken Duisburg
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Munich (Muenchen), 독일, D-81377
- Klinikum Großhadern
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Antwerp, 벨기에, 2020
- Algemeen Ziekenhuis Middelheim
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Brugge, 벨기에, 8000
- A.Z. St. Jan
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Brussels, 벨기에, 1070
- Hopital Universitaire Erasme
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Brussels (Bruxelles), 벨기에, 1000
- Institut Jules Bordet
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Edegem, 벨기에, B-2650
- Universitair Ziekenhuis Antwerpen
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Liege, 벨기에, B-4000
- CHU Sart-Tilman
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Innsbruck, 오스트리아, A-6020
- Universitaetsklinik
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Alessandria, 이탈리아, I-15100
- Ospedale Civile Alessandria
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Ancona, 이탈리아, 60020
- Ospedale Torrette University Ancona
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Avellino, 이탈리아
- Ospedale Civile Avellino
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Bari, 이탈리아, 70124
- Universita Degli Studi di Bari Policlinico
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Brindisi, 이탈리아, I-72100
- Ospedale Regionale A. Di Summa
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Cagliari, 이탈리아, 09124
- Ospedale Oncologico A. Businco
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Catania, 이탈리아, 95124
- Ospedale Ferrarotto
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Catanzaro, 이탈리아, 88100
- Ospedale Regionale A. Pugliese
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Cremona, 이탈리아, 26100
- Centro Trapianti di Midollo Osseo
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Cuneo, 이탈리아, 12100
- Ospedale Santa Croce
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Firenze (Florence), 이탈리아, 1 (50-134)
- Universita Degli Studi di Firenze - Policlin. di Careggi
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Foggia, 이탈리아, 71100
- Ospedali Riuniti Foggia
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Gallarate Varese, 이탈리아, 21013
- Ospedale S. Antonio Abate
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Genoa (Genova), 이탈리아, 16132
- Ospedale San Martino/Cliniche Universitarie Convenzionale
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Latina, 이탈리아, 04100
- Ospedale Gen. Provinciale Santa Maria Goretti
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Lodi, 이탈리아, I-20075
- Ospedale Maggiore Lodi
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Milano (Milan), 이탈리아, 20132
- Instituto Scientifico H.S. Raffaele
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Milano (Milan), 이탈리아, 20162
- Ospedale Maggiore Ca Granda
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Modena, 이탈리아, 41100
- Università di Modena
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Naples (Napoli), 이탈리아, 80127
- Azienda Ospedaliera "A. Cardarelli"
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Naples (Napoli), 이탈리아, 80131
- Federico II University Medical School
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Naples (Napoli), 이탈리아, 80136
- Ospedale S. Gennora USL 42
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Naples (Napoli), 이탈리아, 80144
- Ospedale Nuovo Pellegrini
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Novara, 이탈리아, 28100
- Ospedale Maggiore
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Nuoro, 이탈리아, 08100
- Ospedale San Francesco
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Orbassano, (Torino), 이탈리아, 10043
- Azienda Ospedale S. Luigi - Universita Di Torino
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Palermo, 이탈리아, 90146
- Ospedale Cervello
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Palermo, 이탈리아, 90100
- Policlinico - Cattedra di Ematologia
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Palermo, 이탈리아, 90127
- Policlinico P. Giaccone - Universita Di Palermo
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Parma, 이탈리아, 43100
- Azienda Ospedaliera di Parma
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Pavia, 이탈리아, 27100
- University and I.R.C.C.S. Policlinico San Matteo
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Perugia, 이탈리아, 06122
- Policlinico Monteluce
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Pesaro, 이탈리아, I-61100
- Ospedale San Salvatore
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Pescara, 이탈리아, 65100
- Ospedale Civile Pescara
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Potenza, 이탈리아, 85100
- Ospedale San Carlo
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Reggio Calabria, 이탈리아, 89100
- Ospedali Riuniti
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Reggio Emilia, 이탈리아, 42100
- Arcispedale S. Maria Nuova
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Rome, 이탈리아, 00161
- Azienda Policlinico Umberto Primo
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Rome, 이탈리아, 00168
- Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
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Rome, 이탈리아, 00144
- Ospedale San Eugenio
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San Giovanni - Rotondo, 이탈리아, 71013
- Ospedale Casa Sollievo della Sofferenza
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Sassari, 이탈리아, 07100
- Istituto di Ematologia Universita - University di Sassari
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Sondalo (so), 이탈리아, 23037
- Azienda Ospedaliera Ospedale E. Mortelli
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Taranto, 이탈리아, 74100
- Ospedal SS Annunziata
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Turin (Torino), 이탈리아, 10126
- Ospedale Molinette
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Olomouc, 체코 공화국, 775 20
- University Hospital - Olomouc
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Prague, 체코 공화국, 128 20
- Institute of Hematology and Blood Transfusion
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Ankara, 칠면조, 06100
- Ibn-i Sina Hospital, Ankara Univeristy
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Zagreb, 크로아티아, 41000
- University Hospital Rebro
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Zagreb (Agram), 크로아티아, 41000
- Medical School/University of Zagreb
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Coimbra, 포르투갈, 3049
- Hospitais da Universidade de Coimbra (HUC)
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Porto, 포르투갈, 4200
- Hospital Escolar San Joao
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Lyon, 프랑스, 69437
- Hopital Edouard Herriot
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Nice, 프랑스, 06189
- Centre Antoine Lacassagne
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Paris, 프랑스, 75674
- Hôpital Cochin
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Paris, 프랑스, 75743
- Hôpital Necker
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Paris, 프랑스, 75181
- Hotel Dieu de Paris
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Suresnes, 프랑스, 92151
- Centre Médico-Chirurgical Foch
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Villejuif, 프랑스, F-94805
- Institut Gustave Roussy
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Kecskemet, 헝가리, H-6000
- County Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
공동 작업자 및 조사자
수사관
- 연구 의자: Robert A. Zittoun, MD, Hotel Dieu de Paris
간행물 및 유용한 링크
일반 간행물
- 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. Erratum In: J Clin Oncol. 2010 Mar 10;28(8):1438.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000063311
- EORTC-06931
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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