AzTrials
AzTrials

LeukemiaPhase 3NCT00430118

Combination Chemotherapy Based on Risk of Relapse in Treating Young Patients With Acute Lymphoblastic Leukemia

A Phase 3 study testing asparaginase, cyclophosphamide and cytarabine in people with Leukemia, run by University Hospital Schleswig-Holstein at 76 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Leukemia
What is being tested?
asparaginase, cyclophosphamide and cytarabine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,559 participants
Where
76 sitesin 3 countries
Study dates
Jul 2000to Jan 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

76 sites in 3 countries.

76 sites in 3 countries

Germany60 sites

  • Kinderklinik - Universitaetsklinikum Aachen

    Aachen, D-52074

  • Klinikum Augsburg

    Augsburg, DOH-86156

  • Caritas-Krankenhaus Bad Mergentheim

    Bad Mergentheim, D-97980

  • Klinikum Bayreuth

    Bayreuth, D-95445

  • Helios Klinikum Berlin

    Berlin, 13125

  • Charite University Hospital - Campus Virchow Klinikum

    Berlin, D-13353

  • Kinderklinik der Universitaet Bonn

    Bonn, D-53113

  • Staedtisches Klinikum - Howedestrase

    Braunschweig, 38118

  • Klinikum Chemnitz gGmbH

    Chemnitz, D-09116

  • Klinikum Coburg

    Coburg, 96450

  • Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl

    Cologne, D-50735

  • Children's Hospital

    Cologne, D-50924

  • Carl - Thiem - Klinkum Cottbus

    Cottbus, D-03048

  • Vestische Kinderklinik Universitaetsklinik Witten/Herdecke

    Datteln, 45711

  • Klinikum Lippe - Detmold

    Detmold, D-32756

  • Klinikum Dortmund

    Dortmund, D-44137

  • Universitatsklinikum Carl Gustav Carus

    Dresden, D-01307

  • Klinikum Duisburg

    Duisburg, D-47055

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Universitaets - Kinderklinik

    Erlangen, 91054

  • Universitaetsklinikum Essen

    Essen, D-45147

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Universitaetskinderklinik - Universitaetsklinikum Freiburg

    Freiburg im Breisgau, D-79106

  • Kinderklinik

    Giessen, D-35385

  • Universitaetsklinikum Goettingen

    Göttingen, D-37075

  • Universitaetsklinikum Halle

    Halle, D-06097

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Universitaets-Kinderklinik Heidelberg

    Heidelberg, D-69120

  • SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen

    Heilbronn, D-74064

  • Gemeinschaftskrankenhaus

    Herdecke, 58313

  • Universitaetsklinikum des Saarlandes

    Homburg, 66421

  • Universitaets - Kinderklinik

    Jena, D-07745

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • Klinikum Kassel

    Kassel, D-34125

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24105

  • Klinikum Kemperhof Koblenz

    Koblenz, D-56065

  • Universitaets - Kinderklinik - Luebeck

    Lübeck, D-23538

  • St. Annastift Krankenhaus

    Ludwigshafen, 67065

  • Universitatsklinikum der MA

    Magdeburg, 39120

  • Staedtisches Klinik - Kinderklinik

    Mannheim, D-68167

  • Universitaetsklinikum Giessen und Marburg GmbH - Marburg

    Marburg, D-35043

  • Klinikum Minden

    Minden, D-32423

  • Krankenhaus Muenchen Schwabing

    Munich, 80804

  • Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

    Münster, D-48149

  • Kinderklinik Kohlhof

    Neunkirchen, D-66539

  • Cnopf'sche Kinderklinik

    Nuremberg, 90419

  • Klinikum Oldenburg

    Oldenburg, 26133

  • Kinderklinik - Universitaetsklinikum Rostock

    Rostock, D-18057

  • Saarbrucker Winterbergkliniken

    Saarbrücken, 66119

  • Johanniter-Kinderklinik

    Sankt Augustin, 53757

  • Klinikum Schwerin

    Schwerin, D-19049

  • Kinderklink Siegen Deutsches Rotes Kreuz

    Siegen, D-57072

  • Olgahospital

    Stuttgart, D-70176

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54290

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89075

  • St. Marienhospital - Vechta

    Vechta, D-49377

  • Reinhard-Nieter-Krankenhaus

    Wilhelmshaven, D-26389

  • Klinikum der Stadt Wolfsburg

    Wolfsburg, D-38440

  • Universitaets - Kinderklinik Wuerzburg

    Würzburg, D-97080

Other trials in Germany

Austria10 sites

  • Krankenhaus Dornbirn

    Dornbirn, A-6850

  • Landeskrankenhaus Feldkirch

    Feldkirch-Tisis, A-6807

  • Universitaet Kinderklinik

    Graz, 8036

  • Innsbruck Universitaetsklinik

    Innsbruck, A-6020

  • Landeskrankenhaus Klagenfurt

    Klagenfurt, 9026

  • LKH Leoben

    Leoben, A-8700

  • A. oe. Krankenhaus der Barmherzigen Schwestern Kinderabteilung

    Linz, 4010

  • Landes-Kinderkrankenhaus

    Linz, A-4020

  • St. Johanns-Spital

    Salzburg, A-5020

  • St. Anna Children's Hospital

    Vienna, A-1090

Other trials in Austria

Switzerland6 sites

  • Kantonsspital Aarau

    Aarau, CH-5001

  • Universitaets-Kinderspital beider Basel

    Basel, CH-4005

  • Ospedale "la Carita", Locarno

    Locarno, 6600

  • Kinderspital Luzern

    Lucerne, CH-6000

  • Ostschweizer Kinderspital

    Sankt Gallen, CH-9006

  • University Children's Hospital

    Zurich, CH-8032

Other trials in Switzerland

About this study

Official title: ALL-BFM 2000 Multi-Center Study for the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia

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.

Read the detailed description

OBJECTIVES:

  • Compare the relative efficacy of induction therapy comprising dexamethasone or prednisone, in terms of a higher rate of event-free survival (EFS) and overall survival and a reduced rate of relapse, in pediatric patients with intermediate-risk or high-risk acute lymphoblastic leukemia (ALL).
  • Compare the relative safety of a reduced-intensity reintensification regimen comprising dexamethasone, vincristine, cyclophosphamide, and anthracyclines vs a standard treatment regimen in pediatric patients with standard-risk ALL identified by fast clearance of leukemic cells.
  • Compare the efficacy of a second delayed reintensification regimen vs standard reintensification therapy, in terms of improved EFS, in pediatric patients with intermediate-risk ALL.
  • Compare the efficacy of extended reintensification therapy (triple reinduction) vs standard reintensification therapy (intensive pulses and one reintensification) in pediatric patients with high-risk ALL.

OUTLINE: This is a randomized, multicenter study.

  • Prednisone prephase therapy: Patients receive oral prednisone on days 1-7 and one dose of methotrexate (MTX) intrathecally (IT) on day 1.
  • Induction/consolidation therapy, protocol I: Patients are randomized to 1 of 2 treatment arms.
  • Arm I (closed to accrual as of 6/30/2006): Patients receive prednisone (PRED) on days 8-28.
  • Arm II (closed to accrual as of 6/30/2006): Patients receive dexamethasone (DEXA) on days 8-28.

Patients in both arms also receive vincristine (VCR) and daunorubicin hydrochloride (DNR) once weekly in weeks 2-5; asparaginase (ASP) on days 12-33; cyclophosphamide (CPM) on days 36 and 64; cytarabine (ARA-C) in weeks 6-9; mercaptopurine (MP) on days 36-63; and MTX IT on days 1, 12, 33, 45, and 59.*

NOTE: *Patients with CNS disease also receive MTX IT on days 18 and 27.

After completion of induction/consolidation therapy, patients are stratified according to risk group based on disease response (standard-risk [SR] group [negative minimal residual disease (MRD) on day 33 and before protocol M, day 78] vs high-risk [HR] group [MRD ≥ 10^-³ on day 78] vs intermediate-risk [IR] group [all nonSR/nonHR]).* Patients with SR and IR disease proceed to extracompartment therapy. Patients with HR disease proceed to reintensification therapy.

NOTE: *Patients meeting any of the following criteria are placed in the HR group regardless of MRD response: Philadelphia chromosome-positive disease (BCR/ABL or t[9;22]; translocations [t4;11][q11;q23] or MLL/AF4); "prednisone-poor-response" (≥ 1,000 blasts/mm³ in the peripheral blood on day 8 after prednisone prephase therapy); or no response to study induction therapy (M2/3 at day 33).

  • Extracompartment therapy, protocol M: Patients receive MP on days 1-56 and MTX on days 8, 22, 36, and 50.

After completion of extracompartment therapy, SR and IR patients proceed to reintensification therapy. SR patients are randomized to arms I or II. IR patients are randomized to arms I or III. HR patients who have completed induction/consolidation therapy are randomized to arms IV or V.

  • Reintensification therapy:
  • Arm I (standard reinduction therapy, protocol II [closed to accrual as of 6/30/2006]): SR and IR patients receive DEXA on days 1-22; VCR and doxorubicin hydrochloride (DOX) in weeks 2-5; ASP on days 8, 11, 15, and 18; CPM on day 36; ARA-C and thioguanine (TG) on days 36-49; and MTX IT on days 38 and 45.* Patients then proceed to maintenance therapy.

NOTE: *Patients with CNS disease also receive MTX IT on days 1 and 18.

  • Arm II (reduced-intensity reinduction therapy, protocol III [closed to accrual as of 6/30/2006]): SR patients receive DEXA on days 1-15; VCR and DOX on days 1 and 8; ASP on days 1, 4, 8, and 11; CPM on day 15; ARA-C and TG on days 15-28; and MTX IT on days 17 and 24.* Patients then proceed to maintenance therapy.

NOTE: *Patients with CNS disease also receive MTX on day 1.

  • Arm III (reduced-intensity reinduction/second delayed reinduction therapy [double reintensification therapy] [closed to accrual as of 6/30/2006]): IR patients receive reduced-intensity reintensification therapy as in arm II. After a 10-week interim maintenance phase, treatment repeats once for a second delayed course of reintensification therapy. Patients then proceed to maintenance therapy.
  • Arm IV (standard reintensification therapy [closed to accrual as of 6/30/2006]): HR patients receive two sequences of the following HR therapy elements (i.e., in this order: 1, 2, 3, 1, 2, 3) following reintensification therapy as in arm I. Patients then proceed to maintenance therapy.
  • Element HR-1: Patients receive DEXA on days 1-5; VCR on days 1 and 6; ARA-C twice on day 5; MTX and CPM every 12 hours on days 2-4 (5 doses); ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1.
  • Element HR-2: Patients receive DEXA on days 1-5; vindesine on days 1 and 6; DNR on day 5; MTX and ifosfamide every 12 hours on days 2-4 (5 doses); ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1.* NOTE: *HR patients with CNS disease also receive IT therapy on day 5.
  • Element HR-3: Patients receive DEXA on days 1-5; ARA-C every 12 hours on days 1-2 (4 doses); etoposide five times daily on days 3-5; ASP on days 6 and 11; and MTX/ARA-C/PRED IT on day 1.
  • Arm V (extended reintensification therapy [triple protocol III] [closed to accrual as of 6/30/2006]): HR patients receive HR therapy elements 3, 2, and 1 as in arm IV following reintensification therapy as in arm II repeated the therapy element twice with 4-week interim maintenance phases in between. Patients then proceed to maintenance therapy.
  • Interim maintenance/maintenance therapy: Patients receive MTX once weekly and MP daily until week 104.
  • Radiotherapy: HR patients or patients with T-cell acute lymphoblastic leukemia or CNS disease undergo CNS radiotherapy.

PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Conditions
Leukemia
Being tested
asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone
Keywords
T-cell childhood acute lymphoblastic leukemia, recurrent childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia
Medical subject headings
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00430118
Study groupRoleWhat they receive
Induction Prot I/Dexa - reinduction Prot IIIExperimentalNot described
Receives: Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: thioguanine; Drug: vincristine sulfate; Drug: vindesine; Radiation: radiation therapy
Induction Prot I/Pred - reinduction Prot IIIExperimentalNot described
Receives: Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: thioguanine; Drug: vincristine sulfate; Drug: vindesine; Radiation: radiation therapy
Induction Prot I/Dexa - reinduction Prot IIExperimentalNot described
Receives: Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: thioguanine; Drug: vincristine sulfate; Drug: vindesine; Radiation: radiation therapy
Induction Prot I/Pred - reinduction Prot IIActive comparatorNot described
Receives: Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: thioguanine; Drug: vincristine sulfate; Drug: vindesine; Radiation: radiation therapy
Induction Prot I/Dexa - reinduction 2x Prot IIIExperimentalNot described
Receives: Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: thioguanine; Drug: vincristine sulfate; Drug: vindesine; Radiation: radiation therapy
Induction Prot I/Pred - reinduction 2x Prot IIIExperimentalNot described
Receives: Drug: asparaginase; Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Drug: mercaptopurine; Drug: methotrexate; Drug: prednisone; Drug: thioguanine; Drug: vincristine sulfate; Drug: vindesine; Radiation: radiation therapy
Induction Prot I/Dexa - reinduction 3 HR courses + 3x Prot IIIExperimentalNot described
Receives: 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
Induction Prot I/Pred - reinduction 3 HR courses + 3x Prot IIIExperimentalNot described
Receives: 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
Induction Prot I/Dexa - reinduction 6 HR courses + Prot IIExperimentalNot described
Receives: 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
Induction Prot I/Pred - reinduction 6 HR courses + Prot IIActive comparatorNot described
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of dexamethasone vs prednisone during the induction phase

    Measured: End of Trial

  2. Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients

    Measured: End of Trial

  3. Safety and efficacy of treatment reduction during reintensification in standard-risk patients

    Measured: End of Trial

  4. EFS after second delayed reintensification in intermediate-risk patients

    Measured: End of Trial

  5. Outcome after extended reintensification therapy in high-risk patients

    Measured: End of Trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2007 (estimated)
  2. Study startJul 2000
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
4,559 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00430118
Sponsor's protocol ID
CDR0000528029
Other IDs
ALL-BFM-2000, EU-20682
Status last verified
May 2013
First submitted
30 Jan 2007
Last updated
29 May 2013
Results posted
No

Publications

  • Attarbaschi A, Mann G, Panzer-Grumayer R, Rottgers S, Steiner M, Konig M, Csinady E, Dworzak MN, Seidel M, Janousek D, Moricke 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. doi: 10.1200/JCO.2008.16.1117.

    PubMed 18565891

  • Schrappe M, Valsecchi MG, Bartram CR, Schrauder A, Panzer-Grumayer R, Moricke 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, Schafer BW, Arico 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. doi: 10.1182/blood-2011-03-338707. Epub 2011 Jun 30.

    PubMed 21719599

  • Conter V, Bartram CR, Valsecchi MG, Schrauder A, Panzer-Grumayer R, Moricke A, Arico 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. doi: 10.1182/blood-2009-10-248146. Epub 2010 Feb 12.

    PubMed 20154213

  • 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. doi: 10.1038/leu.2010.203. Epub 2010 Oct 14.

    PubMed 20944675

  • Schrey D, Borghorst S, Lanvers-Kaminsky C, Hempel G, Gerss J, Moricke 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. doi: 10.1002/pbc.22417.

    PubMed 20108339

  • Dworzak MN, Schumich A, Printz D, Potschger 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. doi: 10.1182/blood-2008-06-164129. Epub 2008 Sep 9.

    PubMed 18780832

  • Flohr T, Schrauder A, Cazzaniga G, Panzer-Grumayer R, van der Velden V, Fischer S, Stanulla M, Basso G, Niggli FK, Schafer 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. doi: 10.1038/leu.2008.5. Epub 2008 Jan 31.

    PubMed 18239620

  • Zimmermann M, Denzer C, Moricke A, Alten J, Blank A, Attarbaschi A, Bodmer N, Cario G, Schrappe M, Debatin KM, Fischer-Posovszky P, Zinngrebe J. Excess body weight at diagnosis is associated with inferior ALL outcomes in male adolescents in the ALL-BFM 2000 study. Blood Neoplasia. 2026 Jul 16;3(4):100273. doi: 10.1016/j.bneo.2026.100273. eCollection 2026 Nov.

    PubMed 42830786

  • Junk SV, Schaeffeler E, Zimmermann M, Moricke A, Beier R, Schutte P, Fedders B, Alten J, Hinze L, Klein N, Kulozik A, Muckenthaler MU, Koehler R, Borkhardt A, Vijayakrishnan J, Ellinghaus D, Forster M, Franke A, Wintering A, Kratz CP, Schrappe M, Schwab M, Houlston RS, Cario G, Stanulla M. Chemotherapy-related hyperbilirubinemia in pediatric acute lymphoblastic leukemia: a genome-wide association study from the AIEOP-BFM ALL study group. J Exp Clin Cancer Res. 2023 Jan 13;42(1):21. doi: 10.1186/s13046-022-02585-x.

    PubMed 36639636

  • Stanulla M, Dagdan E, Zaliova M, Moricke A, Palmi C, Cazzaniga G, Eckert C, Te Kronnie G, Bourquin JP, Bornhauser B, Koehler R, Bartram CR, Ludwig WD, Bleckmann K, Groeneveld-Krentz S, Schewe D, Junk SV, Hinze L, Klein N, Kratz CP, Biondi A, Borkhardt A, Kulozik A, Muckenthaler MU, Basso G, Valsecchi MG, Izraeli S, Petersen BS, Franke A, Dorge P, Steinemann D, Haas OA, Panzer-Grumayer R, Cave H, Houlston RS, Cario G, Schrappe M, Zimmermann M; TRANSCALL Consortium; International BFM Study Group. IKZF1plus Defines a New Minimal Residual Disease-Dependent Very-Poor Prognostic Profile in Pediatric B-Cell Precursor Acute Lymphoblastic Leukemia. J Clin Oncol. 2018 Apr 20;36(12):1240-1249. doi: 10.1200/JCO.2017.74.3617. Epub 2018 Mar 2.

    PubMed 29498923

  • Schrappe M, Bleckmann K, Zimmermann M, Biondi A, Moricke A, Locatelli F, Cario G, Rizzari C, Attarbaschi A, Valsecchi MG, Bartram CR, Barisone E, Niggli F, Niemeyer C, Testi AM, Mann G, Ziino O, Schafer B, Panzer-Grumayer R, Beier R, Parasole R, Gohring G, Ludwig WD, Casale F, Schlegel PG, Basso G, Conter V. Reduced-Intensity Delayed Intensification in Standard-Risk Pediatric Acute Lymphoblastic Leukemia Defined by Undetectable Minimal Residual Disease: Results of an International Randomized Trial (AIEOP-BFM ALL 2000). J Clin Oncol. 2018 Jan 20;36(3):244-253. doi: 10.1200/JCO.2017.74.4946. Epub 2017 Nov 17.

    PubMed 29148893

  • Zuna J, Moericke A, Arens M, Koehler R, Panzer-Grumayer R, Bartram CR, Fischer S, Fronkova E, Zaliova M, Schrauder A, Stanulla M, Zimmermann M, Trka J, Stary J, Attarbaschi A, Mann G, Schrappe M, Cario G. Implications of delayed bone marrow aspirations at the end of treatment induction for risk stratification and outcome in children with acute lymphoblastic leukaemia. Br J Haematol. 2016 Jun;173(5):742-8. doi: 10.1111/bjh.13989. Epub 2016 Feb 23.

    PubMed 26913693

  • Moricke A, Zimmermann M, Valsecchi MG, Stanulla M, Biondi A, Mann G, Locatelli F, Cazzaniga G, Niggli F, Arico M, Bartram CR, Attarbaschi A, Silvestri D, Beier R, Basso G, Ratei R, Kulozik AE, Lo Nigro L, Kremens B, Greiner J, Parasole R, Harbott J, Caruso R, von Stackelberg A, Barisone E, Rossig C, Conter V, Schrappe M. Dexamethasone vs prednisone in induction treatment of pediatric ALL: results of the randomized trial AIEOP-BFM ALL 2000. Blood. 2016 Apr 28;127(17):2101-12. doi: 10.1182/blood-2015-09-670729. Epub 2016 Feb 17.

    PubMed 26888258

  • Cario G, Rhein P, Mitlohner R, Zimmermann M, Bandapalli OR, Romey R, Moericke A, Ludwig WD, Ratei R, Muckenthaler MU, Kulozik AE, Schrappe M, Stanulla M, Karawajew L. High CD45 surface expression determines relapse risk in children with precursor B-cell and T-cell acute lymphoblastic leukemia treated according to the ALL-BFM 2000 protocol. Haematologica. 2014 Jan;99(1):103-10. doi: 10.3324/haematol.2013.090225. Epub 2013 Aug 2.

    PubMed 23911702

  • Dorge P, Meissner B, Zimmermann M, Moricke 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.

    PubMed 22875627

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing asparaginase, cyclophosphamide and cytarabine in people with Leukemia, run by University Hospital Schleswig-Holstein at 76 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of dexamethasone vs prednisone during the induction phase (time frame: End of Trial). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00430118, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in