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NCT00114348 · CITED IN SOURCE DOCUMENTS

ALL-REZ BFM 2002: Multi-Center Study for Children With Relapsed Acute Lymphoblastic Leukemia

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE4
Status at capture
COMPLETED
Registry last update
2013-02-04

The protocol ALL-REZ BFM 2002 aims at the optimization of treatment for children with relapsed acute lymphoblastic leukemia. The primary objective of study ALL-REZ BFM 2002 is the randomized comparison of a lower dosed and less intensive, but continuous consolidation therapy with conventional therapy administered in treatment blocks. Outcome measures are the reduction of minimal residual disease (MRD), event-free and overall survival, and the toxicity associated with each treatment strategy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Up to 18 years of age * Morphologically confirmed diagnosis of relapsed non-B ALL or non-B non-Hodgkin lymphoma Exclusion Criteria: * They have completed the 18th year of life at the time the relapse is diagnosed. * Curative therapy is declined either by patient himself/herself or the respective legal guardian * The patient is pregnant * The patient is breast feeding * Essential parts of the relapse therapy are declined either by the patient or his/her legal cannot be administered because of medical reasons. * No consent is given for transmission of data * The patient has a severe concomitant disease that does not allow treatment according to protocol (e.g. malformation syndromes, cardiac malformations, metabolic disorders).
healthy Volunteers
false
maximum Age
18 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Blocktherapie
    intervention Names
    1. Procedure: R-Blocks
    label
    R-Blöcke
    type
    ACTIVE_COMPARATOR
  2. description
    a
    intervention Names
    1. Procedure: Protocol II-Ida
    label
    Prot-II-Ida
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. R-Blöcke
    name
    R-Blocks
    type
    PROCEDURE
  2. arm Group Labels
    1. Prot-II-Ida
    name
    Protocol II-Ida
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
338
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Reduction of MRD
    time Frame
    a
  2. measure
    event-free and overall survival
    time Frame
    a
  3. measure
    the toxicity associated with each treatment strategy
    time Frame
    a
secondary Outcomes
  1. measure
    Improvement of the prognosis in the intermediate risk group using the stratification in treatment arms with and without allogenic SCT based on the MRD result after the second treatment element of induction therapy
    time Frame
    a
Full study description
brief Summary
The protocol ALL-REZ BFM 2002 aims at the optimization of treatment for children with relapsed acute lymphoblastic leukemia. The primary objective of study ALL-REZ BFM 2002 is the randomized comparison of a lower dosed and less intensive, but continuous consolidation therapy with conventional therapy administered in treatment blocks. Outcome measures are the reduction of minimal residual disease (MRD), event-free and overall survival, and the toxicity associated with each treatment strategy.
detailed Description
The study is based on the results of five consecutive trials performed by the ALL-REZ BFM study group since 1983. Thus the study meets the criteria of evidence-based therapy, which has been developed over nearly 20 years. Multi-agent chemotherapy in short intensive courses, which are separated by treatment-free intervals, has proved to be a successful form of induction and consolidation therapy. It is followed by preventative (or therapeutic) cranial irradiation and continuation therapy. A number of risk factors, particularly the time of relapse, site of relapse, and the ALL immunophenotype, allow the stratification of patients into a group that has an acceptable prognosis after treatment with chemotherapy alone and a second group that has a high risk of subsequent recurrence following the achievement of a second remission. The latter group requires further intensification of consolidation therapy by allogenic stem cell transplantation (SCT). To date, the indication for SCT has remained unclear for a large and heterogeneous group of patients with an intermediate prognosis. During the precursor study ALL-REZ BFM 96, however, the amount of minimal residual disease (MRD) determined quantitatively with clonal molecular markers after the second induction therapy element was shown to be a highly significant predictor of relapse-free survival. The primary objective of study ALL-REZ BFM 2002 is the randomized comparison of a lower dosed and less intensive, but continuous consolidation therapy with conventional therapy administered in treatment blocks. Outcome measures are the reduction of MRD, event-free and overall survival, and the toxicity associated with each treatment strategy. The secondary objectives include an improvement of the prognosis in the intermediate risk group using the stratification in treatment arms with and without allogenic SCT based on the MRD result after the second treatment element of induction therapy. An additional aim is to improve the remission induction rate in all groups by increasing the treatment intensity during induction. This is achieved by shortening the intervals between treatment blocks in keeping with the principles of guiding therapy as defined in the protocol. A series of biological companion studies aims to advance our understanding of the disorder and to establish novel prognostic factors that will allow a risk-adapted therapy.
Source references
references
  1. citation
    Taube T, Eckert C, Korner G, Henze G, Seeger K. Real-time quantification of TEL-AML1 fusion transcripts for MRD detection in relapsed childhood acute lymphoblastic leukaemia. Comparison with antigen receptor-based MRD quantification methods. Leuk Res. 2004 Jul;28(7):699-706. doi: 10.1016/j.leukres.2003.11.006.
    pmid
    15158091
    type
    RESULT
  2. citation
    Eckert C, Einsiedel HG, Hartmann R, von Stackelberg A, Volpel S, Guggemos A, Hanzsch N, Kawan L, Seeger K, Henze G. Clonal stability of initial leukemia in a child with central nervous system relapse 7.4 years after bone marrow relapse of common acute lymphoblastic leukemic. Haematologica. 2004 Jul;89(7):ECR23.
    pmid
    15257960
    type
    RESULT
  3. citation
    Wellmann S, Guschmann M, Griethe W, Eckert C, von Stackelberg A, Lottaz C, Moderegger E, Einsiedel HG, Eckardt KU, Henze G, Seeger K. Activation of the HIF pathway in childhood ALL, prognostic implications of VEGF. Leukemia. 2004 May;18(5):926-33. doi: 10.1038/sj.leu.2403332.
    pmid
    15014526
    type
    RESULT
  4. citation
    Herold R, von Stackelberg A, Hartmann R, Eisenreich B, Henze G. Acute lymphoblastic leukemia-relapse study of the Berlin-Frankfurt-Munster Group (ALL-REZ BFM) experience: early treatment intensity makes the difference. J Clin Oncol. 2004 Feb 1;22(3):569-70; author reply 570-1. doi: 10.1200/JCO.2004.99.153. No abstract available.
    pmid
    14752084
    type
    RESULT
  5. citation
    Eckert C, Parker C, Moorman AV, Irving JA, Kirschner-Schwabe R, Groeneveld-Krentz S, Revesz T, Hoogerbrugge P, Hancock J, Sutton R, Henze G, Chen-Santel C, Attarbaschi A, Bourquin JP, Sramkova L, Zimmermann M, Krishnan S, von Stackelberg A, Saha V. Risk factors and outcomes in children with high-risk B-cell precursor and T-cell relapsed acute lymphoblastic leukaemia: combined analysis of ALLR3 and ALL-REZ BFM 2002 clinical trials. Eur J Cancer. 2021 Jul;151:175-189. doi: 10.1016/j.ejca.2021.03.034. Epub 2021 May 16.
    pmid
    34010787
    type
    DERIVED
  6. citation
    Eckert C, Groeneveld-Krentz S, Kirschner-Schwabe R, Hagedorn N, Chen-Santel C, Bader P, Borkhardt A, Cario G, Escherich G, Panzer-Grumayer R, Astrahantseff K, Eggert A, Sramkova L, Attarbaschi A, Bourquin JP, Peters C, Henze G, von Stackelberg A; ALL-REZ BFM Trial Group. Improving Stratification for Children With Late Bone Marrow B-Cell Acute Lymphoblastic Leukemia Relapses With Refined Response Classification and Integration of Genetics. J Clin Oncol. 2019 Dec 20;37(36):3493-3506. doi: 10.1200/JCO.19.01694. Epub 2019 Oct 23.
    pmid
    31644328
    type
    DERIVED
  7. citation
    Karawajew L, Dworzak M, Ratei R, Rhein P, Gaipa G, Buldini B, Basso G, Hrusak O, Ludwig WD, Henze G, Seeger K, von Stackelberg A, Mejstrikova E, Eckert C. Minimal residual disease analysis by eight-color flow cytometry in relapsed childhood acute lymphoblastic leukemia. Haematologica. 2015 Jul;100(7):935-44. doi: 10.3324/haematol.2014.116707. Epub 2015 May 22.
    pmid
    26001791
    type
    DERIVED
  8. citation
    Irving J, Matheson E, Minto L, Blair H, Case M, Halsey C, Swidenbank I, Ponthan F, Kirschner-Schwabe R, Groeneveld-Krentz S, Hof J, Allan J, Harrison C, Vormoor J, von Stackelberg A, Eckert C. Ras pathway mutations are prevalent in relapsed childhood acute lymphoblastic leukemia and confer sensitivity to MEK inhibition. Blood. 2014 Nov 27;124(23):3420-30. doi: 10.1182/blood-2014-04-531871. Epub 2014 Sep 24.
    pmid
    25253770
    type
    DERIVED
  9. citation
    Eckert C, Henze G, Seeger K, Hagedorn N, Mann G, Panzer-Grumayer R, Peters C, Klingebiel T, Borkhardt A, Schrappe M, Schrauder A, Escherich G, Sramkova L, Niggli F, Hitzler J, von Stackelberg A. Use of allogeneic hematopoietic stem-cell transplantation based on minimal residual disease response improves outcomes for children with relapsed acute lymphoblastic leukemia in the intermediate-risk group. J Clin Oncol. 2013 Jul 20;31(21):2736-42. doi: 10.1200/JCO.2012.48.5680. Epub 2013 Jun 17.
    pmid
    23775972
    type
    DERIVED
  10. citation
    Willer A, Gerss J, Konig T, Franke D, Kuhnel HJ, Henze G, von Stackelberg A, Moricke 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. doi: 10.1182/blood-2011-07-367904. Epub 2011 Sep 22.
    pmid
    21940824
    type
    DERIVED
  11. citation
    Shalapour S, Hof J, Kirschner-Schwabe R, Bastian L, Eckert C, Prada J, Henze G, von Stackelberg A, Seeger K. High VLA-4 expression is associated with adverse outcome and distinct gene expression changes in childhood B-cell precursor acute lymphoblastic leukemia at first relapse. Haematologica. 2011 Nov;96(11):1627-35. doi: 10.3324/haematol.2011.047993. Epub 2011 Aug 9.
    pmid
    21828124
    type
    DERIVED
see Also Links
  1. label
    ALL-REZ BFM 2002
Source notices and limitations
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        .32">32</a>,<a href="#cit/section_10.33">33</a>]</p> <div class="pdq-content-list"><ul id="_1917"><li>In the ALL-REZ BFM 2002 (<a href="/clinicaltrials/NCT00114348">NCT00114348</a>) study, an EFS rate of 84% (&#177; 7%) was observed for patients with <em class="gene-name">ETV6</em>::<em class="gene-name">RUNX1</em> ALL w
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        a href="#cit/section_10.33">33</a>]</p> <div class="pdq-content-list"><ul id="_1917"><li>In the ALL-REZ BFM 2002 (<a href="/clinicaltrials/NCT00114348">NCT00114348</a>) study, an EFS rate of 84% (&#177; 7%) was observed for patients with <em class="gene-name">ETV6</em>::<em class="gene-name">RUNX1</em> ALL with bone marr
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        iate analysis, end-reinduction MRD was the strongest independent prognostic factor.</li></ul></div></li><li>In a subsequent BFM study (<a href="/clinicaltrials/NCT00114348">ALL-REZ BFM 2002 [NCT00114348]</a>), patients with intermediate-risk relapse were allocated to allogeneic HSCT if they had high MRD at the end of the first mo
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        MRD was the strongest independent prognostic factor.</li></ul></div></li><li>In a subsequent BFM study (<a href="/clinicaltrials/NCT00114348">ALL-REZ BFM 2002 [NCT00114348]</a>), patients with intermediate-risk relapse were allocated to allogeneic HSCT if they had high MRD at the end of the first month of treatment. Those who had
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      source update dates
      1. context
        Updated: April 21, 2025
        datetime
        2025-04-21T12:00:00Z
        display
        April 21, 2025

    Preserved source evidence · Not medical advice