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Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002700
First Posted: January 27, 2003
Last Update Posted: June 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Acute Leukemia French Association
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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 European Organisation for Research and Treatment of Cancer - EORTC:

Estimated Enrollment: 392
Study Start Date: August 1995
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002700


  Hide Study Locations
Locations
Belgium
Algemeen Ziekenhuis Middelheim
Antwerpen, Belgium, B-2020
A.Z. St. Jan
Brugge, Belgium, 8000
C.H.U. Saint-Pierre
Brussels, Belgium, 1000
Hopital Universitaire Erasme
Brussels, Belgium, 1070
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
CHU Sart-Tilman
Liege, Belgium, B-4000
Centre Hospitalier Peltzer-La Tourelle
Verviers, Belgium, B-4800
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
Hopital Edouard Herriot
Lyon, France, 69437
Hotel Dieu de Paris
Paris, France, 75181
Hopital Necker
Paris, France, 75743
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Germany
Kreiskrankenhaus Meissen
Meissen, Germany, D-01662
Italy
Ospedale Civile Alessandria
Alessandria, Italy, I-15100
Ospedale Civile Avellino
Avellino, Italy
Universita Degli Studi di Bari Policlinico
Bari, Italy, 70124
A. Perrino Hospital
Brindisi, Italy, 72100
Ospedale Ferrarotto
Catania, Italy, 95124
Ospedale Regionale A. Pugliese
Catanzaro, Italy, 88100
Ospedale Santa Croce
Cuneo, Italy, 12100
Policlinico di Careggi
Firenze (Florence), Italy, 50134
Ospedali Riuniti Foggia
Foggia, Italy, 71100
Ospedale S. Antonio Abate
Gallarate Varese, Italy, 21013
Ospedale Gen. Provinciale Santa Maria Goretti
Latina, Italy, 04100
Ospedale Maggiore Lodi
Lodi, Italy, I-20075
Ospedale Di Montefiascone
Montefiascone, Italy, I-01027
Ospedale S. Gennaro ASL NA1
Naples (Napoli), Italy, 80136
Policlinico - Cattedra di Ematologia
Palermo, Italy, 90100
Policlinico Monteluce
Perugia, Italy, 06122
Ospedale San Carlo
Potenza, Italy, 85100
Ospedale Casa Sollievo della Sofferenza
San Giovanni - Rotondo, Italy, 71013
Istituto di Ematologia Universita - University di Sassari
Sassari, Italy, 07100
Ospedal SS Annunziata
Taranto, Italy, 74100
Ospedale Molinette
Turin (Torino), Italy, 10126
Netherlands
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, Netherlands, 5211 NL
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
Maxima Medisch Centrum - locatie Eindhoven
Eindhoven, Netherlands, 5631 BM
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
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 Organisation for Research and Treatment of Cancer - EORTC
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

Publications:
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.
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.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00002700     History of Changes
Other Study ID Numbers: EORTC-06951
FRE-LALA-94
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: June 12, 2013
Last Verified: June 2013

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Dexamethasone
Prednisone
Prednisolone
Hydrocortisone
Liposomal doxorubicin
Cyclophosphamide
Doxorubicin
Methotrexate
Cytarabine
Vincristine
Mitoxantrone
Daunorubicin
Asparaginase
6-Mercaptopurine
BB 1101
Levoleucovorin