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Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 4, 2009   History of Changes
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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 392
Study Start Date: August 1995
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma with more than 30% blasts in bone marrow

PATIENT CHARACTERISTICS:

Age:

  • 15 to 60

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin less than 2 mg/dL (unless elevation due to leukemic involvement of liver)

Renal:

  • Creatinine less than 2 mg/dL (unless elevation due to leukemic involvement of kidneys)

Cardiovascular:

  • No severe cardiac disease

Pulmonary:

  • No severe pulmonary disease

Other:

  • No severe neurologic or metabolic disease
  • HIV negative (if tested)
  • No other prior malignancy except nonmelanomatous skin cancer, stage I cervical carcinoma, or other curatively treated malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • No prior endocrine therapy

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • No prior surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002700

  Hide Study Locations
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
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Acute Leukemia French Association
Investigators
Study Chair: Roel Willemze, MD, PhD Leiden University Medical Center
Study Chair: Denis Fiere, MD Acute Leukemia French Association
  More Information

Additional Information:
Publications:
Le QH, Thomas X, Ecochard R, Iwaz J, Lheritier V, Michallet M, Fiere D. Proportion of long-term event-free survivors and lifetime of adult patients not cured after a standard acute lymphoblastic leukemia therapeutic program: adult acute lymphoblastic leukemia-94 trial. Cancer. 2007 May 15;109(10):2058-67.
Tavernier E, Boiron JM, Huguet F, Bradstock K, Vey N, Kovacsovics T, Delannoy A, Fegueux N, Fenaux P, Stamatoullas A, Tournilhac O, Buzyn A, Reman O, Charrin C, Boucheix C, Gabert J, Lheritier V, Vernant JP, Dombret H, Thomas X; GET-LALA Group; Swiss Group for Clinical Cancer Research SAKK; Australasian Leukaemia and Lymphoma Group. Outcome of treatment after first relapse in adults with acute lymphoblastic leukemia initially treated by the LALA-94 trial. Leukemia. 2007 Sep;21(9):1907-14. Epub 2007 Jul 5.
Vey N, Thomas X, Picard C, Kovascovicz T, Charin C, Cayuela JM, Dombret H, Dastugue N, Huguet F, Bastard C, Stamatoulas A, Giollant M, Tournilhac O, Macintyre E, Buzyn A, Bories D, Kuentz M, Dreyfus F, Delannoy A, Raynaud S, Gratecos N, Bordessoule D, de Botton S, Preudhomme C, Reman O, Troussard X, Pigneux A, Bilhou C, Vernant JP, Boucheix C, Gabert J; GET-LALA Group the Swiss Group for Clinical Cancer Research (SAKK). Allogeneic stem cell transplantation improves the outcome of adults with t(1;19)/E2A-PBX1 and t(4;11)/MLL-AF4 positive B-cell acute lymphoblastic leukemia: results of the prospective multicenter LALA-94 study. Leukemia. 2006 Dec;20(12):2155-61. Epub 2006 Oct 12.
Asnafi V, Buzyn A, Thomas X, Huguet F, Vey N, Boiron JM, Reman O, Cayuela JM, Lheritier V, Vernant JP, Fiere D, Macintyre E, Dombret H. Impact of TCR status and genotype on outcome in adult T-cell acute lymphoblastic leukemia: a LALA-94 study. Blood. 2005 Apr 15;105(8):3072-8. Epub 2005 Jan 6.
Thomas X, Boiron JM, Huguet F, Dombret H, Bradstock K, Vey N, Kovacsovics T, Delannoy A, Fegueux N, Fenaux P, Stamatoullas A, Vernant JP, Tournilhac O, Buzyn A, Reman O, Charrin C, Boucheix C, Gabert J, Lheritier V, Fiere D. Outcome of treatment in adults with acute lymphoblastic leukemia: analysis of the LALA-94 trial. J Clin Oncol. 2004 Oct 15;22(20):4075-86. Epub 2004 Sep 7.
Asnafi V, Buzyn A, Thomas X, et al.: Impact of immunophenotype and genotype on outcome in LALA94 T-ALLs: toward risk adapted stratification of adult T-ALL. [Abstract] Blood 102 (11): A-67, 2003.
Dombret H, Gabert J, Boiron JM, Rigal-Huguet F, Blaise D, Thomas X, Delannoy A, Buzyn A, Bilhou-Nabera C, Cayuela JM, Fenaux P, Bourhis JH, Fegueux N, Charrin C, Boucheix C, Lheritier V, Esperou H, MacIntyre E, Vernant JP, Fiere D; Groupe d'Etude et de Traitement de la Leucemie Aigue Lymphoblastique de l'Adulte (GET-LALA Group). Outcome of treatment in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia--results of the prospective multicenter LALA-94 trial. Blood. 2002 Oct 1;100(7):2357-66.
Reman O, Pigneux A, Huguet F, et al.: Central nervous system involvement in adult acute lymphoblastic leukemia (ALL) at diagnosis and/or at first elapse: results from the GET-LALA group. [Abstract] Blood 110 (11): A-4326, 2007.
Tavernier E, Le QH, de Botton S, Dhédin N, Bulabois CE, Reman O, Vey N, Lhéritier V, Dombret H, Thomas X. Secondary or concomitant neoplasms among adults diagnosed with acute lymphoblastic leukemia and treated according to the LALA-87 and LALA-94 trials. Cancer. 2007 Oct 26;110(12):2747-2755 [Epub ahead of print]
Dhédin N, Dombret H, Thomas X, Lhéritier V, Boiron JM, Rigal-Huguet F, Vey N, Kuentz M, Reman O, Witz F, Delannoy A, Kovacsovics T, Bradstock K, Charrin C, Boucheix C, Gabert J, Blaise D, Fière D, Vernant JP. Autologous stem cell transplantation in adults with acute lymphoblastic leukemia in first complete remission: analysis of the LALA-85, -87 and -94 trials. Leukemia. 2006 Feb;20(2):336-44.
Picard C, Hayette S, Bilhou-Nabera C, Cayuela JM, Delabesse E, Frenoy N, Preudhomme C, Dupont M, Bastard C, Bories D, Vaerman JL, Davi F, Dastugue N, Raynaud S, Lafage M, Deschaseaux F, Fest T, Gaub MP, Lheritier V, Thomas X, Charrin C, Boucheix C, Dombret H, Macintyre E, Fiere D, Gabert J. Prospective multicentric molecular study for poor prognosis fusion transcripts at diagnosis in adult B-lineage ALL patients: the LALA 94 experience. Leukemia. 2006 Dec;20(12):2178-81. Epub 2006 Oct 12. No abstract available.
Charrin C, Thomas X, Ffrench M, Le QH, Andrieux J, Mozziconacci MJ, Lai JL, Bilhou-Nabera C, Michaux L, Bernheim A, Bastard C, Mossafa H, Perot C, Maarek O, Boucheix C, Lheritier V, Delannoy A, Fiere D, Dastugue N. A report from the LALA-94 and LALA-SA groups on hypodiploidy with 30 to 39 chromosomes and near-triploidy: 2 possible expressions of a sole entity conferring poor prognosis in adult acute lymphoblastic leukemia (ALL). Blood. 2004 Oct 15;104(8):2444-51. Epub 2004 Mar 23.
Boissel N, Auclerc MF, Lheritier V, Perel Y, Thomas X, Leblanc T, Rousselot P, Cayuela JM, Gabert J, Fegueux N, Piguet C, Huguet-Rigal F, Berthou C, Boiron JM, Pautas C, Michel G, Fiere D, Leverger G, Dombret H, Baruchel A. Should adolescents with acute lymphoblastic leukemia be treated as old children or young adults? Comparison of the French FRALLE-93 and LALA-94 trials. J Clin Oncol. 2003 Mar 1;21(5):774-80. Epub 2003 Mar 1.

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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 22, 2009