International Study for Treatment of Standard Risk Childhood Relapsed Acute Lymphoblastic Leukemia 2010

Phase 1

Conditions: Acute lymphoblastic leukemia (ALL)
MedDRA version: 19.1Level: LLTClassification code 10063626Term: Acute lymphocytic leukemia recurrentSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-000793-30-BE

Lead Sponsor: Charité - University Hospital of Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 640

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 640
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• BCR-ABL / t(9;22) positive ALL
• Pregnancy or positive pregnancy test (urine sample positive for ß-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)
•
• Subjects unwilling or unable to comply with the study procedures
• Subjects who are legally detained in an official institute