International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2024
• Main ID: NCT01802814
• Date of registration: 18/02/2013
• Prospective Registration: Yes
• Primary sponsor: Charite University, Berlin, Germany
• Public title: International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010
• 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
• Date of first enrolment: May 2014
• Target sample size: 700
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01802814
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Czech Republic, Czechia, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Sweden, Switzerland, United Kingdom

Contacts

• Name: Arend von Stackelberg, MD
• Affiliation: University Hospital of Berlin - Charité

Key inclusion & exclusion 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 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 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)

- Karnovsky / Lansky score < 50%

- Subjects unwilling or unable to comply with the study procedures

- Subjects who are legally detained in an official institute



Age minimum: 1 Day
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Lymphoblastic Leukemia (ALL)

Intervention(s)

Drug: SR-B + Epratuzumab

Drug: SR-A + Epratuzumab

Primary Outcome(s)

SR consolidation +/- epratuzumab (randomisation 2) [Time Frame: Up to 9 years]

SR induction/consolidation ALL-REZ BFM 2002 versus UK-ALL-R3 (randomisation 1) [Time Frame: Up to 9 years]

Secondary Outcome(s)

SR induction/consolidation [Time Frame: Up to 9 years]

SR consolidation +/- epratuzumab [Time Frame: Up to 9 years]

Secondary ID(s)

IntReALL SR 2010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital Motol (Co-Sponsor Czech Republic)

Australian & New Zealand Children's Haematology/Oncology Group

Copenhagen University Hospital (Rigshospitalet) (Co-Sponsor Copenhagen)

European Organisation for Research and Treatment of Cancer - EORTC

Turku University (Co-Sponsor Finland)

University Children's Hospital, Zurich

Central Manchester University (Co-Sponsor United Kingdom)

National Hospital Organization Nagoya Medical Center (Co-Sponsor Japan)

Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel)

Medical University of Wroclaw (Co-Sponsor Poland)

Ospedale Pediatrico Bambino Gesù (Co-Sponsor Italy)

Our Lady's Chilrden's Hospital (Co-Sponsor Ireland)

Instituto Português de Oncologia de Lisboa (Co-Sponsor Lisboa)

Oslo University Hospital (Co-Sponsor Oslo)

Centre Hospitalier Universitaire de Nice

Prinses Máxima Centrum (Co-Sponsor Netherlands)

Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain)

St. Anna Kinderkrebsforschung (Co-Sponsor Austria)