Status:
COMPLETED
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Australian & New Zealand Children's Haematology/Oncology Group
St. Anna Kinderkrebsforschung (Co-Sponsor Austria)
Conditions:
Acute Lymphoblastic Leukemia (ALL)
Eligibility:
All Genders
1-17 years
Phase:
PHASE3
Brief Summary
The main goal of this study is to improve the outcome of children and adolescents with standard risk (SR) first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large internatio...
Detailed Description
ALL is the most frequent malignancy in childhood and has favourable event-free and overall survival rates. About 15% of patients suffer relapse. At relapse prognosis is much inferior (about 50% surviv...
Eligibility Criteria
Inclusion
- 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 B-cell precursor (BCP) bone marrow (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
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT01802814
Start Date
May 1 2014
End Date
July 31 2023
Last Update
February 9 2024
Active Locations (17)
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1
Australian & New Zealand Childhood Hematology & Oncology Group
Clayton, Victoria, Australia, 3168
2
St. Anna Kinderkrebsforschung, CCRI
Vienna, Austria, 1090
3
Hòpital Universitaire des Enfants Reine Fabiola
Brussels, Belgium, 1020
4
University Hospital Motol
Prague, Czechia