Trial purpose
Cancer treatment
Tumor type
Haematological
Age
0 - 17
Trial acronym
IntReALL SR 2010
Clinical summary
Summary
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.
Conditions
This trial is treating people with Acute Lymphoblastic Leukaemia
Eligibility
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
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
University Hospital of Berlin
Scientific 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
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