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SNCTP000000969 | NCT01802814

Internationale Studie zur Behandlung von rezidivierender ALL 2010 mit Standard-Risiko bei Kindern

Data source: BASEC (Imported from 27.01.2022), WHO (Imported from 18.01.2022)
Changed: 20.12.2020
Disease category: Leukemia

Brief description of trial (Data source: BASEC)

In dieser Studie werden zwei bewährte Behandlungsprotokolle verglichen, von welchen nicht bekannt ist, ob eine der beiden wirksamer sein könnte. Das ist Ziel ist, für die zukünftige Behandlung für ganz Europa ein gemeinsames Behandlungsprotokoll festzulegen. Beide Therapiekonzepte haben hervorragende Ergebnisse erbracht, sind auf sehr ähnlichen Medikamenten aufgebaut, und unterscheiden sich über die Zusammensetzung der einzelnen Therapieelemente. Beide haben Vor- und Nachteile. Am besten lassen sich beide Konzepte vergleichen, wenn in ganz Europa zufällig entschieden werden kann, welcher Patient nach welchem Plan behandelt wird. Zu Beginn der Studie werden die Studienteilnehmer nach Einwilligung einem von folgenden Behandlungsarmen A oder B zugeteilt. Die Wahrscheinlichkeit, dass ein Studienpatient in die Gruppe A oder B kommt beträgt je 50%.
Eine zweite Zuteilung fand ursprünglich nach ungefähr 4 Wochen statt. Hier ging es darum, ob der Patient zur Chemotherapie das neue Medikament Epratuzumab erhält oder nicht. Es wird vermutet, dass Epratuzumab in Kombination mit Chemotherapie eine Verbesserung der Prognose bewirken könnte. Deshalb wurde dieses Medikament in beiden Behandlungskonzepten ebenfalls eingesetzt, d.h. in beiden Behandlungsarmen erhielt die Hälfe aller Patienten zusätzlich zu den anderen Zytostatika Epratuzumab, die andere Hälfte nicht. Die Aufteilung zur zusätzlichen Gabe von Epratuzumab im Rahmen dieser Studie wurde am 01.02.2019 beendet.

Health conditions investigated (Data source: BASEC)

Rückfall akuter lymphoblastischer Leukämie (ALL)

Health conditions (Data source: WHO)

Acute Lymphoblastic Leukemia (ALL)

Rare disease (Data source: BASEC)

Yes

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Zwei bewährte Behandlungsprotokolle mit oder ohne Epratuzumab (zusätzliche Gabe von Epratuzumab wurde am 01.09.2019 beendet).

Interventions (Data source: WHO)

Drug: SR-A + Epratuzumab;Drug: SR-B + Epratuzumab

Criteria for participation in trial (Data source: BASEC)

Bestätigte Diagnose eines ersten Rückfalls der Vorläufer B-Zell- oder T-Zell-ALL.
Standard-Risikokriterien: spät isoliert oder zu spät / früh kombinierter B-Zell-Vorläufer-Knochenmark-Rückfalls

Exclusion criteria (Data source: BASEC)

BCR-ABL / t (9;22) positive ALL, Schwangerschaft, Verweigerung von Verhütungsmethoden

Inclusion/Exclusion Criteria (Data source: WHO)


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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT01802814

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT01802814

Further information on trial

Date trial registered

18.02.2013

Incorporation of the first participant

01.05.2014

Recruitment status

Active, not recruiting

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

SR induction/consolidation ALL-REZ BFM 2002 versus UK-ALL-R3 (randomisation 1);SR consolidation +/- epratuzumab (randomisation 2)

Secundary end point (Data source: WHO)

SR induction/consolidation;SR consolidation +/- epratuzumab

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Aarau, Basel, Bellinzona, Bern, Geneva, Lausanne, Luzern, St. Gallen, Zurich

Countries (Data source: WHO)

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

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Bourquin Jean-Pierre
+41 (0) 44 266 73 04
Jean-Pierre.Bourquin@kispi.uzh.ch

Contact for general information (Data source: WHO)

Arend von Stackelberg, MD
University Hospital of Berlin - Charité

Contact for scientific information (Data source: WHO)

Arend von Stackelberg, MD
University Hospital of Berlin - Charité

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Charite University, Berlin, Germany

Additional sponsors (Data source: WHO)

Australian and New Zealand Children's Haematology/Oncology Group;St. Anna Kinderkrebsforschung (Co-Sponsor Austria);European Organisation for Research and Treatment of Cancer - EORTC;University Hospital Motol (Co-Sponsor Czech Republic);Copenhagen University Hospital (Rigshospitalet) (Co-Sponsor Copenhagen);Turku University (Co-Sponsor Finland);Centre Hospitalier Universitaire de Nice;Our Lady's Chilrden's Hospital (Co-Sponsor Ireland);Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel);Ospedale Pediatrico Bambino Gesù (Co-Sponsor Italy);National Hospital Organization Nagoya Medical Center (Co-Sponsor Japan);Prinses Máxima Centrum (Co-Sponsor Netherlands);Oslo University Hospital (Co-Sponsor Oslo);Medical University of Wroclaw (Co-Sponsor Poland);Instituto Português de Oncologia de Lisboa (Co-Sponsor Lisboa);Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain);University Hospital Stockholm (Co-Sponsor Sweden);University Children's Hospital Zurich (Co-Sponsor Switzerland);Central Manchester University (Co-Sponsor United Kingdom)

Further trial identification numbers

Secondary ID (Data source: WHO)

IntReALL SR 2010