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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Collaborator: |
Acute Leukemia French Association |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002700 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Bone marrow transplantation can replace immune cells that were destroyed by chemotherapy.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with or without bone marrow transplantation in treating patients with acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A RANDOMIZED PHASE III TRIAL COMPARING DEXAMETHASONE WITH PREDNISONE IN INDUCTION TREATMENT AND BONE MARROW TRANSPLANTATION WITH INTENSIVE MAINTENANCE TREATMENT IN ADOLESCENT AND ADULT ACUTE LYMPHOBLASTIC LEUKEMIA (ALL-4) |
Eligibility| Ages Eligible for Study: | 15 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| Belgium | |
| A.Z. St. Jan | |
| Brugge, Belgium, 8000 | |
| Algemeen Ziekenhuis Middelheim | |
| Antwerpen, Belgium, B-2020 | |
| C.H.U. Saint-Pierre | |
| Brussels, Belgium, 1000 | |
| Centre Hospitalier Peltzer-La Tourelle | |
| Verviers, Belgium, B-4800 | |
| CHU Sart-Tilman | |
| Liege, Belgium, B-4000 | |
| Hopital Universitaire Erasme | |
| Brussels, Belgium, 1070 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Croatia | |
| Medical School/University of Zagreb | |
| Zagreb (Agram), Croatia, 10000 | |
| University Hospital Rebro | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| University Hospital - Olomouc | |
| Olomouc, Czech Republic, 775 20 | |
| France | |
| Centre Medico-Chirurgical Foch | |
| Suresnes, France, 92151 | |
| Hopital Edouard Herriot | |
| Lyon, France, 69437 | |
| Hopital Necker | |
| Paris, France, 75743 | |
| Hotel Dieu de Paris | |
| Paris, France, 75181 | |
| Germany | |
| Kreiskrankenhaus Meissen | |
| Meissen, Germany, D-01662 | |
| Italy | |
| A. Perrino Hospital | |
| Brindisi, Italy, 72100 | |
| Istituto di Ematologia Universita - University di Sassari | |
| Sassari, Italy, 07100 | |
| Ospedale Di Montefiascone | |
| Montefiascone, Italy, I-01027 | |
| Ospedale Casa Sollievo della Sofferenza | |
| San Giovanni - Rotondo, Italy, 71013 | |
| Ospedale Civile Alessandria | |
| Alessandria, Italy, I-15100 | |
| Ospedale Civile Avellino | |
| Avellino, Italy | |
| Ospedal SS Annunziata | |
| Taranto, Italy, 74100 | |
| Ospedale Ferrarotto | |
| Catania, Italy, 95124 | |
| Ospedale Gen. Provinciale Santa Maria Goretti | |
| Latina, Italy, 04100 | |
| Ospedale Maggiore Lodi | |
| Lodi, Italy, I-20075 | |
| Ospedale Molinette | |
| Turin (Torino), Italy, 10126 | |
| Ospedale Regionale A. Pugliese | |
| Catanzaro, Italy, 88100 | |
| Ospedale S. Antonio Abate | |
| Gallarate Varese, Italy, 21013 | |
| Policlinico - Cattedra di Ematologia | |
| Palermo, Italy, 90100 | |
| Ospedale San Carlo | |
| Potenza, Italy, 85100 | |
| Ospedale Santa Croce | |
| Cuneo, Italy, 12100 | |
| Ospedali Riuniti Foggia | |
| Foggia, Italy, 71100 | |
| Ospedale S. Gennaro ASL NA1 | |
| Naples (Napoli), Italy, 80136 | |
| Policlinico di Careggi | |
| Firenze (Florence), Italy, 50134 | |
| Policlinico Monteluce | |
| Perugia, Italy, 06122 | |
| Universita Degli Studi di Bari Policlinico | |
| Bari, Italy, 70124 | |
| Netherlands | |
| Groot Ziekengasthuis 's-Hertogenbosch | |
| 's-Hertogenbosch, Netherlands, 5211 NL | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| Maxima Medisch Centrum - locatie Eindhoven | |
| Eindhoven, Netherlands, 5631 BM | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Portugal | |
| Hospital Escolar San Joao | |
| Porto, Portugal, 4200 | |
| Slovakia | |
| Institute of Hematology & Transfusiology, University Hospital | |
| Bratislava, Slovakia, 85107 | |
| Turkey | |
| Ibn-i Sina Hospital | |
| Ankara, Turkey, 06100 | |
| Study Chair: | Roel Willemze, MD, PhD | Leiden University Medical Center |
| Study Chair: | Denis Fiere, MD | Acute Leukemia French Association |
More Information
| Study ID Numbers: | CDR0000064498, EORTC-06951, FRE-LALA-94 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002700 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated adult acute lymphoblastic leukemia stage I adult lymphoblastic lymphoma stage III adult lymphoblastic lymphoma |
stage IV adult lymphoblastic lymphoma contiguous stage II adult lymphoblastic lymphoma noncontiguous stage II adult lymphoblastic lymphoma |
|
Anti-Inflammatory Agents Dexamethasone Prednisone Anti-Infective Agents Hydrocortisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Hormones Therapeutic Uses Abortifacient Agents Methotrexate |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Hydrocortisone acetate Mitoxantrone Antineoplastic Agents, Phytogenic |