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

This study has been completed.
Sponsor:
Collaborator:
Deutsche Kinderkrebsstiftung
Information provided by (Responsible Party):
Gunter Henze, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00114348
First received: June 14, 2005
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Lymphoblastic Leukemia, Acute
Lymphoma, Non-Hodgkin
Procedure: R-Blocks
Procedure: Protocol II-Ida
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ALL-REZ BFM 2002: Protocol for the Treatment of Children With Relapsed Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Reduction of MRD [ Time Frame: a ] [ Designated as safety issue: No ]
  • event-free and overall survival [ Time Frame: a ] [ Designated as safety issue: Yes ]
  • the toxicity associated with each treatment strategy [ Time Frame: a ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 338
Study Start Date: August 2003
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: R-Blöcke
Blocktherapie
Procedure: R-Blocks
Experimental: Prot-II-Ida
a
Procedure: Protocol II-Ida

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114348

Locations
Germany
ALL-REZ Studienzentrale
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Deutsche Kinderkrebsstiftung
Investigators
Principal Investigator: Günter Henze, Prof.Dr.med. GPOH
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gunter Henze, Clinic director, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00114348     History of Changes
Other Study ID Numbers: A2002/6a
Study First Received: June 14, 2005
Last Updated: February 1, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
non-B ALL
relapse
treatment
Relapsed non-B ALL or non-B non-Hodgkin lymphoma

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 24, 2014