Brève description de l’étude (Source de données: BASEC)
Die akute lymphoblastische Leukämie (kurz ALL) ist die häufigste Art von Blutkrebs im Kindes- und Jugendalter. Die Durchführung von internationalen Studien konnte die Prognose von ALL bereits erheblich verbessern. Es wurden verschiedene Risikofaktoren gefunden, die wichtig für die Heilungsaussichten der Patienten sind.
Patienten mit mehr Risikofaktoren und somit einer höheren Rückfallwahrscheinlichkeit benötigen eine intensivere Therapie, die auch mit mehr Nebenwirkungen verbunden ist. Für Patienten mit weniger Risikofaktoren reicht hingegen eine schwächere Therapie, die mit weniger Nebenwirkungen verbunden ist. Ziel dieser Studie ist es, die bestmögliche Therapie für alle Risikogruppen zu finden. Dies nach dem Prinzip "so viel wie nötig, so wenig wie möglich". Die Therapie sollte somit intensiv genug sein, um Rückfälle der Leukämie zu verhindern, jedoch nicht intensiver als zwingend erforderlich, um Nebenwirkungen bestmöglich zu vermeiden.
Maladies étudiées(Source de données: BASEC)
Akute lymphoblastische Leukämie (ALL)
Health conditions
(Source de données: WHO)
acute lymphoblastic leukemia in children and adolescents <18 yearsof age;Therapeutic area: Diseases [C] - Cancer [C04]
Maladie rare
(Source de données: BASEC)
Non
Intervention étudiée (p. ex., médicament, thérapie, campagne)
(Source de données: BASEC)
In dieser Studie werden die Patienten anhand der zuvor erwähnten Risikofaktoren in verschiedene Gruppen mit unterschiedlicher Rückfallwahrscheinlichkeit eingeteilt. Die Einteilung erfolgt aufgrund von Laborergebnissen, welche Informationen über die Eigenschaften der Leukämie jedes einzelnen Patienten liefern. Auch während der Therapie werden diese Eigenschaften weiter untersucht um sicherzustellen, dass jeder Patient in der jeweiligen Therapiephase, nach wie vor der richtigen Gruppe zugeteilt ist.
Die Stärke der Therapie ist dem Rückfallrisiko der Behandlungsgruppe angepasst. In einzelnen Gruppen werden neue Medikamente getestet. Die Patienten erhalten entweder die Standard-Chemotherapie, oder die Standardtherapie zusammen mit neuen Medikamenten. Welcher Patient welche Behandlung erhält wird zufällig entschieden. So können Vor- und Nachteile der neuen Medikamente direkt verglichen und die Therapie für zukünftige Patienten weiter verbessert werden.
Interventions
(Source de données: WHO)
Pharmaceutical Form:
INN or Proposed INN: MERCAPTOPURINE
CAS Number: 50-44-2
Pharmaceutical Form:
INN or Proposed INN: TIOGUANINE
CAS Number: 154-42-7
Trade Name: Erwinase
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CRISANTASPASE
CAS Number: 9015-68-3
Current Sponsor code: Erwinase
Other descriptive name: CRISANTASPASE
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 10000-
Trade Name: Oncaspar
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PEGASPARGASE
CAS Number: 130167-69-0
Current Sponsor code: PEG-Asparaginase
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 3750-
Pharmaceutical Form:
INN or Proposed INN: DAUNORUBICIN
CAS Number: 20830-81-3
Pharmaceutical Form:
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Other descriptive name: PREDNISOLONE
Pharmaceutical Form:
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Other descriptive name: PREDNISONE
Pharmaceutical Form:
INN or Proposed INN: CYCLOPHOSPHAMIDE
CAS Number: 50-18-0
Pharmaceutical Form:
INN or Proposed INN: ETOPOSIDE PHOSPHATE
CAS Number: 117091-64-2
Other descriptive name: ETOPOSIDE PHOSPHATE
Pharmaceutical Form:
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Other descriptive name: METHOTREXATE
Pharmaceutical Form:
INN or Proposed INN: CYTARABINE
CAS Number: 147-94-4
Other descriptive name: CYTARABINE
Pharmaceutical Form:
INN or Proposed INN: ETOPOSIDE
CAS Number: 33419-42-0
Other descriptive name: ETOPOSIDE
Pharmaceutical Form:
INN or Proposed INN: VINCRISTINE
CAS Number: 57-22-7
Pharmaceutical Form:
INN or Proposed INN: IFOSFAMIDE
CAS Number: 3778-73-2
Phar
Critères de participation à l’étude
(Source de données: BASEC)
• Erste ALL Diagnose oder erste Diagnose von akuter Leukämie mit spezifischen genetischen Veränderungen (MPAL)
• Patienten unter 18 Jahren zum Zeitpunkt der ALL Diagnose
Critères d’exclusion
(Source de données: BASEC)
• Schwangerschaft
• Teilnahme an andere klinische Studien
• Krankheit erlaubt keine Behandlung nach dem Protokoll
Inclusion/Exclusion Criteria
(Source de données: WHO)
Gender:
Female: yes
Male: yes
Inclusion criteria:
- newly diagnosed acute lymphoblastic leukemia, from 1st September 2023 onwards only acute lymphoblastic leukemia with T-cell phenotype or
- newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:
? biphenotypic with a dominant T or B lineage assignment,from 1st September 2023 onwards only those with a dominant T lineage assignment,
?bilineal either with a dominant lymphoblastic (from 1st September 2023 onwards only T lymphoblastic) population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
- newly diagnosed acute undifferentiated leukemia
- age < 18 years (up to 17 years and 365 days) at the day of diagnosis
- patient enrolled in a participating center
- written informed consent to trial participation and transfer and processing of data
Are the trial subjects under 18? yes
Number of subjects for this age range: 5000
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:
- Ph+ (BCR-ABL1 or t(9;22)-positive) ALL
- bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (= 10% of total cells) blast subset
- pre-treatment with cytostatic drugs
- glucocorticoid pre-treatment with = 1 mg/kg/d Prednisolone equivalent for more than two weeks during the last month before diagnosis
- treatment started according to another protocol
- underlying diseases that does not allow treatment according to the protocol
- ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
- evidence of pregnancy or lactation period
- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
- participation in another clinical trial that interferes with the protocol
-other condition (either pre-existing or related to leukemia biology as present at diagnosis) or circumstances that significantly conflict with the treatment according to the protocol
-
Plus d’informations sur l’étude
Date d’enregistrement de l’étude
19 févr. 2018
Intégration du premier participant
2 juil. 2018
Statut de recrutement
Authorised-recruitment may be ongoing or finished
Titre scientifique
(Source de données: WHO)
AIEOP-BFM ALL 2017 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia - AIEOP-BFM ALL 2017
Type d’étude
(Source de données: WHO)
Interventional clinical trial of medicinal product
Conception de l’étude
(Source de données: WHO)
Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 14
Phase
(Source de données: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Points finaux primaires
(Source de données: WHO)
Main Objective: - Randomization R-eHR: Early high-risk (early HR) pB-ALL defined by genetics and/or inadequate treatment response over the course of induction: Can the pEFS from time of randomization be improved by additional therapy with the proteasome inhibitor Bortezomib during an extended consolidation treatment phase compared to standard extended consolidation?
- Randomization R-HR: High-risk (HR) pB-ALL defined by genetics and/or inadequate treatment response by the end of consolidation: Can the pEFS from time of randomization be improved by a treatment concept including two cycles of post-consolidation immunotherapy with Blinatumomab (15 ?g/m?/d for 28 days per cycle) plus 4 doses intrathecal Methotrexate compared to two conventional highly intensive chemotherapy courses?
(continued in field for another language)
;Secondary Objective: - All randomizations: Can the overall survival be improved by the treatment in the experimental arm?
- All randomizations: What is the incidence of treatment-related toxicities and mortality in the experimental arm compared to the standard arm?
- Randomization R-eHR: Can the MRD load after consolidation treatment be reduced by the additional treatment with Bortezomib?
- Randomization R-HR: Can treatment-related life-threatening complications and mortality during the intensified consolidation phase of high-risk treatment be reduced when replacing two intensive chemotherapy courses by two cycles of immunotherapy with Blinatumomab?
(continued in field for another language)
;Primary end point(s): For the randomized study questions, the primary endpoint will be the time from randomization until the first event defined as follows:
Randomization R-eHR, R-HR and R-T: Cytomorphological or molecular non-response (resistance to protocol treatment, considered as event at day zero), relapse, second malignancy or death from any cause. This will be called EFS time.
Randomization R-MR: Relapse, second malignancy or death from any cause. This will be called DFS time.
;Timepoint(s) of evaluation of this end point: EFS and DFS time: end of study
Points finaux secondaires
(Source de données: WHO)
Secondary end point(s): - Survival starting at the same time point as the EFS/DFS
- Frequency and incidence of treatment-related mortality in induction or CCR
- Frequency and incidence of AE of interest and SAE in specific protocol phases, randomized arms and overall during follow-up
- MRD load after the randomized treatment phases (R-eHR, R-HR, R-MR and R-T)
- MRD load after the first/second cycle of Blinatumomab or after the HR 2?/HR 3? block (R-HR)
- Proportion of patients with poor MRD response to the first Blinatumomab cycle (?Blinatumomab Poor-Response?) (R HR)
;Timepoint(s) of evaluation of this end point: Survival, treatment-related mortality, AE and SAE: end of study
MRD related endpoints: after the repective MRD evaluation of the last patient in study
Contact pour informations
(Source de données: WHO)
Deutsche Krebshilfe
Résultats de l’étude
(Source de données: WHO)
Résumé des résultats
AIEOP-BFM ALL 2017 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
Lien vers les résultats dans le registre primaire
pas encore d’informations disponibles
Informations sur la disponibilité des données individuelles des participants
pas encore d’informations disponibles
Lieux de réalisation des études
Lieux de réalisation des études en Suisse
(Source de données: BASEC)
Aarau, Bâle, Bellinzona, Berne, Genève, Lausanne, Luzern, St-Gall, Zurich
Pays où sont réalisées les études
(Source de données: WHO)
Australia, Austria, Czech Republic, Czechia, Germany, Israel, Italy, Slovakia, Switzerland
Contact pour plus d’informations sur l’étude
Données sur la personne de contact en Suisse
(Source de données: BASEC)
Dr. med. Nicole Bodmer
+41 44 266 74 55
nicole.bodmer@kispi.uzh.ch
Contact pour des informations générales
(Source de données: WHO)
Study Coordinator
Arnold-Heller-Str. 3, Haus U 18
Universit?tsklinikum Schleswig-Holstein, Campus Kiel
all-bfm-studie@pediatrics.uni-kiel.de
Contact pour des informations scientifiques
(Source de données: WHO)
Study Coordinator
Arnold-Heller-Str. 3, Haus U 18
Universit?tsklinikum Schleswig-Holstein, Campus Kiel
all-bfm-studie@pediatrics.uni-kiel.de
Autorisation de la commission d’éthique (Source de données: BASEC)
Nom de la commission d’éthique chargée de l’autorisation (dans le cas d’études multicentriques, uniquement la commission directrice)
Kantonale
Ethikkommission Zürich
Date d’autorisation de la commission d’éthique
30.07.2019
Plus de numéros d’identification d’étude
Numéro d’identification de l’étude de la commission d’éthique (BASEC-ID)
(Source de données: BASEC)
2019-00755
Secondary ID (Source de données: WHO)
AIEOP-BFM-ALL-2017
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