Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003798

Trial Description

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Title

ALL-REZ BFM 2002: Protocol for the Treatment of Children With Relapsed Acute Lymphoblastic Leukemia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00003798
  •   2012/05/04
  •   2005/06/14
  •   yes
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Secondary IDs

  •   NCT00114348  (ClinicalTrials.gov)
  •   A2002/6a  (Charite University, Berlin, Germany)
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Health Condition or Problem studied

  •   Lymphoblastic Leukemia, Acute
  •   Lymphoma, Non-Hodgkin
  •   C91.0 -  Acute lymphoblastic leukaemia
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Interventions/Observational Groups

  •   Procedure: R-Blocks
  •   Procedure: Protocol II-Ida
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   [---]*
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Primary Outcome

- Reduction of MRD; time frame: a
- event-free and overall survival; time frame: a
- the toxicity associated with each treatment strategy; time frame: a

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2003/08/31
  •   338
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   18   Years
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Additional Inclusion Criteria

- Up to 18 years of age

- Morphologically confirmed diagnosis of relapsed non-B ALL or non-B non-Hodgkin
lymphoma

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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).

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Addresses

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    • Charite University, Berlin, Germany
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    • GPOH
    • Günter Henze, Prof.Dr.med. 
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    • GPOH
    • Günter Henze, Prof.Dr.med. 
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    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2012/07/01
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Trial Publications, Results and other Documents

  •   ALL-REZ BFM 2002
  •   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.; 15158091
  •   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.; 15257960
  •   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. Erratum in: Leukemia. 2004 Jun;18(6):1164. Stackelberg Av [corrected to von Stackelberg A].; 15014526
  •   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. No abstract available.; 14752084
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.