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Spots Global Cancer Trial Database for Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Acute Myelogenous Leukemia

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Trial Identification

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

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

Study ID: NCT00002549

Conditions

Leukemia

Study Description

Brief 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. 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.

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.

Eligibility

Minimum Age: 15 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Universitaetsklinik, Innsbruck, , Austria

Algemeen Ziekenhuis Middelheim, Antwerp, , Belgium

A.Z. St. Jan, Brugge, , Belgium

Institut Jules Bordet, Brussels (Bruxelles), , Belgium

Hopital Universitaire Erasme, Brussels, , Belgium

Universitair Ziekenhuis Antwerpen, Edegem, , Belgium

CHU Sart-Tilman, Liege, , Belgium

Medical School/University of Zagreb, Zagreb (Agram), , Croatia

University Hospital Rebro, Zagreb, , Croatia

University Hospital - Olomouc, Olomouc, , Czech Republic

Institute of Hematology and Blood Transfusion, Prague, , Czech Republic

Hopital Edouard Herriot, Lyon, , France

Centre Antoine Lacassagne, Nice, , France

Hotel Dieu de Paris, Paris, , France

Hopital Cochin, Paris, , France

Hopital Necker, Paris, , France

Centre Medico-Chirurgical Foch, Suresnes, , France

Institut Gustave Roussy, Villejuif, , France

Staedtische Kliniken Duisburg, Duisburg, , Germany

Klinikum Grosshadern, Munich (Muenchen), , Germany

County Hospital, Kecskemet, , Hungary

Ospedale Civile Alessandria, Alessandria, , Italy

Ospedale Torrette University Ancona, Ancona, , Italy

Ospedale Civile Avellino, Avellino, , Italy

Universita Degli Studi di Bari Policlinico, Bari, , Italy

Ospedale Regionale A. Di Summa, Brindisi, , Italy

Ospedale Oncologico A. Businco, Cagliari, , Italy

Ospedale Ferrarotto, Catania, , Italy

Ospedale Regionale A. Pugliese, Catanzaro, , Italy

Centro Trapianti di Midollo Osseo, Cremona, , Italy

Ospedale Santa Croce, Cuneo, , Italy

Universita Degli Studi di Firenze - Policlin. di Careggi, Firenze (Florence), , Italy

Ospedali Riuniti Foggia, Foggia, , Italy

Ospedale S. Antonio Abate, Gallarate Varese, , Italy

Ospedale San Martino/Cliniche Universitarie Convenzionale, Genoa (Genova), , Italy

Ospedale Gen. Provinciale Santa Maria Goretti, Latina, , Italy

Ospedale Maggiore Lodi, Lodi, , Italy

Instituto Scientifico H.S. Raffaele, Milano (Milan), , Italy

Ospedale Maggiore Ca Granda, Milano (Milan), , Italy

Universita di Modena, Modena, , Italy

Azienda Ospedaliera "A. Cardarelli", Naples (Napoli), , Italy

Federico II University Medical School, Naples (Napoli), , Italy

Ospedale S. Gennora USL 42, Naples (Napoli), , Italy

Ospedale Nuovo Pellegrini, Naples (Napoli), , Italy

Ospedale Maggiore, Novara, , Italy

Ospedale San Francesco, Nuoro, , Italy

Azienda Ospedale S. Luigi - Universita Di Torino, Orbassano, (Torino), , Italy

Policlinico - Cattedra di Ematologia, Palermo, , Italy

Policlinico P. Giaccone - Universita Di Palermo, Palermo, , Italy

Ospedale Cervello, Palermo, , Italy

Azienda Ospedaliera Di Parma, Parma, , Italy

University and I.R.C.C.S. Policlinico San Matteo, Pavia, , Italy

Policlinico Monteluce, Perugia, , Italy

Ospedale San Salvatore, Pesaro, , Italy

Ospedale Civile Pescara, Pescara, , Italy

Ospedale San Carlo, Potenza, , Italy

Ospedali Riuniti, Reggio Calabria, , Italy

Arcispedale S. Maria Nuova, Reggio Emilia, , Italy

Ospedale San Eugenio, Rome, , Italy

Azienda Policlinico Umberto Primo, Rome, , Italy

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore, Rome, , Italy

Ospedale Casa Sollievo della Sofferenza, San Giovanni - Rotondo, , Italy

Istituto di Ematologia Universita - University di Sassari, Sassari, , Italy

Azienda Ospedaliera Ospedale E. Mortelli, Sondalo (so), , Italy

Ospedal SS Annunziata, Taranto, , Italy

Ospedale Molinette, Turin (Torino), , Italy

Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch, , Netherlands

Onze Lieve Vrouwe Gasthuis, Amsterdam, , Netherlands

Medisch Spectrum Twente, Enschede, , Netherlands

Leiden University Medical Center, Leiden, , Netherlands

University Medical Center Nijmegen, Nijmegen, , Netherlands

Sint Joseph Ziekenhuis, Veldhoven, , Netherlands

Hospitais da Universidade de Coimbra (HUC), Coimbra, , Portugal

Hospital Escolar San Joao, Porto, , Portugal

Ibn-i Sina Hospital, Ankara Univeristy, Ankara, , Turkey

Contact Details

Name: Robert A. Zittoun, MD

Affiliation: Hotel Dieu de Paris

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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