NCT00114348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2005

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 4, 2013

Status Verified

February 1, 2013

Enrollment Period

8.9 years

First QC Date

June 14, 2005

Last Update Submit

February 1, 2013

Conditions

Lymphoblastic Leukemia, AcuteLymphoma, Non-Hodgkin

Keywords

non-B ALLrelapsetreatmentRelapsed non-B ALL or non-B non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (3)

  • Reduction of MRD

    a

  • event-free and overall survival

    a

  • the toxicity associated with each treatment strategy

    a

Secondary Outcomes (1)

  • 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

    a

Study Arms (2)

R-Blöcke

ACTIVE COMPARATOR

Blocktherapie

Procedure: R-Blocks

Prot-II-Ida

EXPERIMENTAL

a

Procedure: Protocol II-Ida

Interventions

R-BlocksPROCEDURE
R-Blöcke
Protocol II-IdaPROCEDURE
Prot-II-Ida

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Up to 18 years of age
  • Morphologically confirmed diagnosis of relapsed non-B ALL or non-B non-Hodgkin lymphoma

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ALL-REZ Studienzentrale

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (11)

  • 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: 15158091RESULT

  • 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: 15257960RESULT

  • 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: 15014526RESULT

  • 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: 14752084RESULT

  • 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: 34010787DERIVED

  • 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: 31644328DERIVED

  • 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: 26001791DERIVED

  • 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: 25253770DERIVED

  • 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: 23775972DERIVED

  • 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: 21940824DERIVED

  • 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: 21828124DERIVED

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Non-HodgkinRecurrence

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphomaDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Günter Henze, Prof.Dr.med.

    German Society for Pediatric Oncology and Hematology GPOH gGmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinic director

Study Record Dates

First Submitted

June 14, 2005

First Posted

June 15, 2005

Study Start

August 1, 2003

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 4, 2013

Record last verified: 2013-02

Locations

DE(1)