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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Collaborator: |
Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002701 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of combination chemotherapy with or without bone marrow transplantation is more effective in treating promyelocytic leukemia
PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens with or without bone marrow transplantation in treating patients who have promyelocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: idarubicin Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: thioguanine Drug: tretinoin Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | INDUCTION WITH ALL-TRANS RETINOIC ACID IN COMBINATION WITH IDARUBICIN AND INTENSIVE CONSOLIDATION FOLLOWED BY BONE MARROW TRANSPLANTATION OR A RANDOMIZED MAINTENANCE TREATMENT DEPENDING UPON THE AMOUNT OF MINIMAL RESIDUAL DISEASE IN ACUTE PROMYELOCYTIC LEUKEMIA |
Eligibility| Ages Eligible for Study: | 16 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| Austria | |
| Innsbruck Universitaetsklinik | |
| Innsbruck, Austria, A-6020 | |
| Belgium | |
| A.Z. St. Jan | |
| Brugge, Belgium, 8000 | |
| Algemeen Ziekenhuis Middelheim | |
| Antwerp, Belgium, 2020 | |
| C.H.U. Saint-Pierre | |
| Brussels (Bruxelles), Belgium, 1000 | |
| Institut Jules Bordet | |
| Brussels (Bruxelles), Belgium, 1000 | |
| CHU Sart-Tilman | |
| Liege, Belgium, B-4000 | |
| Hopital Universitaire Erasme | |
| Brussels, Belgium, 1070 | |
| Centre Hospitalier Peltzer-La Tourelle | |
| Verviers, Belgium, B-4800 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Croatia | |
| Medical School/University of Zagreb | |
| Zagreb (Agram), Croatia, 41000 | |
| University Hospital Rebro | |
| Zagreb, Croatia, 41000 | |
| Czech Republic | |
| Onkologicka Klinka A Onkologicka Lab | |
| Prague, Czech Republic, 128 08 | |
| France | |
| Hopital Edouard Herriot | |
| Lyon, France, 69437 | |
| Centre Hospitalier Regional de Lille | |
| Lille, France, 59037 | |
| Centre Medico-Chirurgical Foch | |
| Suresnes, France, 92151 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Hopital Necker | |
| Paris, France, 75743 | |
| Hotel Dieu de Paris | |
| Paris, France, 75181 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Germany | |
| Klinikum Duisburg | |
| Duisburg, Germany, D-47055 | |
| Klinikum Grosshadern | |
| Munich (Muenchen), Germany, D-81377 | |
| Italy | |
| Azienda Ospedaliera "A. Cardarelli" | |
| Naples (Napoli), Italy, 80127 | |
| Azienda Ospedaliera di Padova | |
| Padova (Padua), Italy, 35128 | |
| Azienda Ospedaliera Di Parma | |
| Parma, Italy, 43100 | |
| Azienda Policlinico Umberto Primo | |
| Rome, Italy, 00161 | |
| Ospedale Cervello | |
| Palermo, Italy, 90146 | |
| Centro Trapianti di Midollo Osseo | |
| Cremona, Italy, 26100 | |
| Federico II University Medical School | |
| Naples (Napoli), Italy, 80131 | |
| I.R.C.C.S. Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| Istituto di Ematologia Universita - University di Sassari | |
| Sassari, Italy, 07100 | |
| Istituto Scientifico H.S. Raffaele | |
| Milano, Italy, 20132 | |
| Ospedal SS Annunziata | |
| Taranto, Italy, 74100 | |
| Ospedale Casa Sollievo della Sofferenza | |
| San Giovanni - Rotondo, Italy, 71013 | |
| Cattedra di Immunologia Clinica | |
| Turin (TO), Italy, 10128 | |
| Ospedale Civile Alessandria | |
| Alessandria, Italy, I-15100 | |
| Ospedale Civile Avellino | |
| Avellino, Italy | |
| Ospedale Civile Pescara | |
| Pescara, Italy, 65100 | |
| Ospedale Di Montefiascone | |
| Montefiascone, Italy, I-01027 | |
| Ospedale Ferrarotto | |
| Catania, Italy, 95124 | |
| Ospedale Gen. Provinciale Santa Maria Goretti | |
| Latina, Italy, 04100 | |
| Ospedale Maggiore Ca Granda | |
| Milano (Milan), Italy, 20162 | |
| Ospedale Maggiore Lodi | |
| Lodi, Italy, I-20075 | |
| Ospedale Molinette | |
| Turin (Torino), Italy, 10126 | |
| Ospedale San Francesco | |
| Nuoro, Italy, 08100 | |
| Ospedale Oncologico A. Businco | |
| Cagliari, Italy, 09124 | |
| Ospedale Regionale A. Di Summa | |
| Brindisi, Italy, I-72100 | |
| Ospedale Regionale A. Pugliese | |
| Catanzaro, Italy, 88100 | |
| Ospedale S. Antonio Abate | |
| Gallarate Varese, Italy, 21013 | |
| Ospedale S. Gennora USL 42 | |
| Naples (Napoli), Italy, 80136 | |
| Ospedale San Carlo | |
| Potenza, Italy, 85100 | |
| Ospedale San Eugenio | |
| Rome, Italy, 00144 | |
| Ospedale Nuovo Pellegrini | |
| Naples (Napoli), Italy, 80144 | |
| Ospedale San Martino/Cliniche Universitarie Convenzionate | |
| Genoa (Genova), Italy, 16132 | |
| Ospedale San Salvatore | |
| Pesaro, Italy, I-61100 | |
| Ospedale Santa Croce | |
| Cuneo, Italy, 12100 | |
| Ospedale Torrette University Ancona | |
| Ancona, Italy, 60020 | |
| Ospedali Riuniti Foggia | |
| Foggia, Italy, 71100 | |
| Policlinico Monteluce | |
| Perugia, Italy, 06122 | |
| Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | |
| Rome, Italy, 00168 | |
| Policlinico di Careggi | |
| Firenze (Florence), Italy, 50134 | |
| Policlinico - Cattedra di Ematologia | |
| Palermo, Italy, 90100 | |
| Universita Degli Studi di Bari Policlinico | |
| Bari, Italy, 70124 | |
| Netherlands | |
| Academisch Medisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Academisch Ziekenhuis Groningen | |
| Groningen, Netherlands, 9713 EZ | |
| Groot Ziekengasthuis 's-Hertogenbosch | |
| 's-Hertogenbosch, Netherlands, 5211 NL | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| Leyenburg Ziekenhuis | |
| 's-Gravenhage (Den Haag, The Hague), Netherlands, 2545 CH | |
| University Hospital - Rotterdam Dijkzigt | |
| Rotterdam, Netherlands, 3000 CA | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Turkey | |
| Ibn-i Sina Hospital, Ankara University | |
| Ankara, Turkey, 06100 | |
| Study Chair: | Petra Muus, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
| Study Chair: | Franco Mandelli, MD | Azienda Policlinico Umberto Primo |
More Information
| Study ID Numbers: | CDR0000064499, EORTC-06952, ITA-GIMEMA-AIEOP-1 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002701 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated adult acute myeloid leukemia adult acute promyelocytic leukemia (M3) |
|
Neoplasm, Residual Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents 6-Mercaptopurine Cyclophosphamide Antibiotics, Antineoplastic Leukemia, Myeloid, Acute Keratolytic Agents Leukemia |
Neoplastic Processes Pathologic Processes Sensory System Agents Therapeutic Uses Abortifacient Agents Leukemia, Promyelocytic, Acute Methotrexate Analgesics Dermatologic Agents Alkylating Agents Etoposide Nucleic Acid Synthesis Inhibitors Cytarabine Neoplasms by Histologic Type Thioguanine |
