International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by University Hospital of Berlin
Sponsor:
Information provided by (Responsible Party):
University Hospital of Berlin
ClinicalTrials.gov Identifier:
NCT01802814
First received: February 18, 2013
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

The main goal of this study is to improve the outcome of children and adolescents with standard risk first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.


Condition Intervention Phase
Acute Lymphoblastic Leukemia (ALL)
Drug: SR-A + Epratuzumab
Drug: SR-B + Epratuzumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

Resource links provided by NLM:


Further study details as provided by University Hospital of Berlin:

Primary Outcome Measures:
  • SR induction/consolidation ALL-REZ BFM 2002 versus UK-ALL-R3 (randomisation 1) [ Time Frame: at 4 years of arm A ] [ Designated as safety issue: No ]
    SR induction/consolidation ALL-REZ BFM 2002 versus UK-ALL-R3 (randomisation 1): 10% pEFS superiority of arm B above a 65% pEFS at 4 years of arm A

  • SR consolidation +/- epratuzumab (randomisation 2) [ Time Frame: at 4 years of standard arm ] [ Designated as safety issue: No ]
    SR consolidation +/- epratuzumab (randomisation 2): 10% pEFS superiority of the arm with epratuzumab above an expected 74% pEFS at 4 years of the standard arm


Secondary Outcome Measures:
  • SR induction/consolidation [ Time Frame: year 7 ] [ Designated as safety issue: No ]
    SR induction/consolidation: comparison of OS, toxicity, rate of CR2, and rate of MRD between treatment groups

  • SR consolidation +/- epratuzumab [ Time Frame: year 7 ] [ Designated as safety issue: No ]
    SR consolidation +/- epratuzumab: comparison of OS, toxicity, MRD levels, rate of MRD and evaluation of pharmacokinetic parameters of Epratuzumab


Estimated Enrollment: 1242
Study Start Date: June 2013
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: SR-A
Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized not to receive epratuzumab.
Active Comparator: SR-A + Epratuzumab
Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized to receive epratuzumab.
Drug: SR-A + Epratuzumab
Other Name: Epratuzumab
No Intervention: SR-B
Patients randomized to the SR-B Arm receive induction, post-induction and maintenance therapy according to the protocol ALL-R3. In this arm patients are randomized not to receive epratuzumab.
Active Comparator: SR-B + Epratuzumab
Patients randomized to the SR-B Arm receive induction, post-induction and maintenance therapy according to the protocol ALL-R3. In this arm patients are randomized to receive epratuzumab.
Drug: SR-B + Epratuzumab
Other Name: Epratuzumab

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
  • Children less than 18 years of age at inclusion
  • Meeting SR criteria: late isolated or late/early combined BCP BM relapse, any late/early isolated extramedullary relapse
  • Patient enrolled in a participating centre
  • Written informed consent
  • Start of treatment falling into the study period
  • No participation in other clinical trials 30 days prior to study enrolment that interfere with this protocol, except trials for primary ALL Inclusion criteria specific for the epratuzumab randomization
  • Precursor B-cell immunophenotype. A specific CD22 expression level is not required
  • M1 or M2 status of the bone marrow after induction

Exclusion Criteria:

  • BCR-ABL / t(9;22) positive ALL
  • Pregnancy or positive pregnancy test (urine sample positive for β-HCG > 10 U/l)
  • Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 2 years after end of antileukemic therapy
  • Breast feeding
  • Relapse post allogeneic stem-cell transplantation
  • The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
  • No consent is given for saving and propagation of pseudonymized medical data for study reasons
  • Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
  • Karnovsky / Lansky score < 50%
  • Subjects unwilling or unable to comply with the study procedures
  • Subjects who are legally detained in an official institute
  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: NCT01802814

Contacts
Contact: Arend von Stackelberg, MD +49(0)30-450666 ext 833 arend.stackelberg@charite.de

  Show 19 Study Locations
Sponsors and Collaborators
University Hospital of Berlin
Investigators
Principal Investigator: Arend von Stackelberg, MD University Hospital of Berlin - Charité
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital of Berlin
ClinicalTrials.gov Identifier: NCT01802814     History of Changes
Other Study ID Numbers: IntReALL SR 2010
Study First Received: February 18, 2013
Last Updated: February 28, 2013
Health Authority: Australia and New Zealand: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Paul-Ehrlich-Institut
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Authority of Medicines and Health Products (Infarmed)
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospital of Berlin:
ALL

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

ClinicalTrials.gov processed this record on August 28, 2014