Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With Acute Lymphoblastic Leukemia - Full Text View

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia.

PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.

Condition	Intervention	Phase
Leukemia	Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Drug: vindesine Radiation: radiation therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	ALL-BFM 2000 Multi-Center Study for the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Chronic Lymphocytic Leukemia Leukemia Steroids

Drug Information available for: Dexamethasone Cyclophosphamide Mercaptopurine Prednisone Methotrexate Cytarabine Thioguanine Dexamethasone acetate Vincristine sulfate Dexamethasone sodium phosphate Ifosfamide Asparaginase Methotrexate sodium Daunorubicin Doxorubicin Daunorubicin hydrochloride Doxorubicin hydrochloride Etoposide Etoposide phosphate Daunorubicin citrate

U.S. FDA Resources

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

Primary Outcome Measures:

Efficacy of dexamethasone vs prednisone during the induction phase [ Designated as safety issue: No ]
Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients [ Designated as safety issue: No ]
Safety and efficacy of treatment reduction during reintensification in standard-risk patients [ Designated as safety issue: Yes ]
EFS after second delayed reintensification in intermediate-risk patients [ Designated as safety issue: No ]
Outcome after extended reintensification therapy in high-risk patients [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	July 2000

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Year to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed acute lymphoblastic leukemia (ALL)
No secondary ALL

PATIENT CHARACTERISTICS:

No prior disease that would preclude treatment with chemotherapy

PRIOR CONCURRENT THERAPY:

More than 4 weeks since prior chemotherapy
More than 4 weeks since prior steroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430118

Show 76 Study Locations

Sponsors and Collaborators

University of Schleswig-Holstein

Investigators

Study Chair:

Martin Schrappe, MD, PhD

University of Schleswig-Holstein

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Schrappe M, Valsecchi MG, Bartram CR, Schrauder A, Panzer-Grümayer R, Möricke A, Parasole R, Zimmermann M, Dworzak M, Buldini B, Reiter A, Basso G, Klingebiel T, Messina C, Ratei R, Cazzaniga G, Koehler R, Locatelli F, Schäfer BW, Aricò M, Welte K, van Dongen JJ, Gadner H, Biondi A, Conter V. Late MRD response determines relapse risk overall and in subsets of childhood T-cell ALL: results of the AIEOP-BFM-ALL 2000 study. Blood. 2011 Aug 25;118(8):2077-84. Epub 2011 Jun 30.

Conter V, Bartram CR, Valsecchi MG, Schrauder A, Panzer-Grümayer R, Möricke A, Aricò M, Zimmermann M, Mann G, De Rossi G, Stanulla M, Locatelli F, Basso G, Niggli F, Barisone E, Henze G, Ludwig WD, Haas OA, Cazzaniga G, Koehler R, Silvestri D, Bradtke J, Parasole R, Beier R, van Dongen JJ, Biondi A, Schrappe M. Molecular response to treatment redefines all prognostic factors in children and adolescents with B-cell precursor acute lymphoblastic leukemia: results in 3184 patients of the AIEOP-BFM ALL 2000 study. Blood. 2010 Apr 22;115(16):3206-14. Epub 2010 Feb 12.

Kox C, Zimmermann M, Stanulla M, Leible S, Schrappe M, Ludwig WD, Koehler R, Tolle G, Bandapalli OR, Breit S, Muckenthaler MU, Kulozik AE. The favorable effect of activating NOTCH1 receptor mutations on long-term outcome in T-ALL patients treated on the ALL-BFM 2000 protocol can be separated from FBXW7 loss of function. Leukemia. 2010 Dec;24(12):2005-13. Epub 2010 Oct 14.

Schrey D, Borghorst S, Lanvers-Kaminsky C, Hempel G, Gerss J, Möricke A, Schrappe M, Boos J. Therapeutic drug monitoring of asparaginase in the ALL-BFM 2000 protocol between 2000 and 2007. Pediatr Blood Cancer. 2010 Jul 1;54(7):952-8.

Kox C, Zimmermann M, Stanulla M, et al.: The favorable effect of activating NOTCH1 receptor mutations on long term outcome in T-ALL is treatment related and can be separated from NOTCH pathway activation by FBXW7 loss of function. [Abstract] Blood 114 (22): A-908, 2009.

Dworzak MN, Schumich A, Printz D, Pötschger U, Husak Z, Attarbaschi A, Basso G, Gaipa G, Ratei R, Mann G, Gadner H. CD20 up-regulation in pediatric B-cell precursor acute lymphoblastic leukemia during induction treatment: setting the stage for anti-CD20 directed immunotherapy. Blood. 2008 Nov 15;112(10):3982-8. Epub 2008 Sep 9.

Flohr T, Schrauder A, Cazzaniga G, Panzer-Grümayer R, van der Velden V, Fischer S, Stanulla M, Basso G, Niggli FK, Schäfer BW, Sutton R, Koehler R, Zimmermann M, Valsecchi MG, Gadner H, Masera G, Schrappe M, van Dongen JJ, Biondi A, Bartram CR; International BFM Study Group (I-BFM-SG). Minimal residual disease-directed risk stratification using real-time quantitative PCR analysis of immunoglobulin and T-cell receptor gene rearrangements in the international multicenter trial AIEOP-BFM ALL 2000 for childhood acute lymphoblastic leukemia. Leukemia. 2008 Apr;22(4):771-82. Epub 2008 Jan 31.

Attarbaschi A, Mann G, Panzer-Grümayer R, Röttgers S, Steiner M, König M, Csinady E, Dworzak MN, Seidel M, Janousek D, Möricke A, Reichelt C, Harbott J, Schrappe M, Gadner H, Haas OA. Minimal residual disease values discriminate between low and high relapse risk in children with B-cell precursor acute lymphoblastic leukemia and an intrachromosomal amplification of chromosome 21: the Austrian and German acute lymphoblastic leukemia Berlin-Frankfurt-Munster (ALL-BFM) trials. J Clin Oncol. 2008 Jun 20;26(18):3046-50.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dörge P, Meissner B, Zimmermann M, Möricke A, Schrauder A, Bouquin JP, Schewe D, Harbott J, Teigler-Schlegel A, Ratei R, Ludwig WD, Koehler R, Bartram CR, Schrappe M, Stanulla M, Cario G. IKZF1 deletion is an independent predictor of outcome in pediatric acute lymphoblastic leukemia treated according to the ALL-BFM 2000 protocol. Haematologica. 2013 Mar;98(3):428-32. doi: 10.3324/haematol.2011.056135. Epub 2012 Aug 8.

Zeidler L, Zimmermann M, Möricke A, Meissner B, Bartels D, Tschan C, Schrauder A, Cario G, Goudeva L, Jäger S, Ratei R, Ludwig WD, Teigler-Schlegel A, Skokowa J, Koehler R, Bartram CR, Riehm H, Schrappe M, Welte K, Stanulla M. Low platelet counts after induction therapy for childhood acute lymphoblastic leukemia are strongly associated with poor early response to treatment as measured by minimal residual disease and are prognostic for treatment outcome. Haematologica. 2012 Mar;97(3):402-9. Epub 2011 Nov 4.

Willer A, Gerss J, König T, Franke D, Kühnel HJ, Henze G, von Stackelberg A, Möricke A, Schrappe M, Boos J, Lanvers-Kaminsky C. Anti-Escherichia coli asparaginase antibody levels determine the activity of second-line treatment with pegylated E coli asparaginase: a retrospective analysis within the ALL-BFM trials. Blood. 2011 Nov 24;118(22):5774-82. Epub 2011 Sep 22.

ClinicalTrials.gov Identifier:	NCT00430118 History of Changes
Other Study ID Numbers:	CDR0000528029, ALL-BFM-2000, EU-20682
Study First Received:	January 30, 2007
Last Updated:	November 1, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

T-cell childhood acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Thioguanine
Cyclophosphamide
Isophosphamide mustard

Asparaginase
Daunorubicin
Dexamethasone
Doxorubicin
Etoposide
Ifosfamide
Prednisone
Vincristine
Vindesine
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013