Protocol GRAALL-2014 Multicenter study on the treatment of acute lymphoblastic leukemia (ALL) in young adults (18–59 years) – including 3 sub-studies.
Summary description of the study
This clinical study focuses on a form of blood cancer called acute lymphoblastic leukemia (ALL) in young adults. It is divided into three parts, according to the type of ALL: B-cell ALL T-cell ALL Philadelphia-positive ALL For each group, the objective is different: For B and T-cell ALL: the aim is to confirm a new method that estimates the risk of relapse, based on genetic markers and the presence of residual cancer cells. For patients with high-risk T-cell ALL: a specific drug called Nelarabine is added to the treatment to reduce the risk of relapse. For patients with Philadelphia-positive ALL: researchers want to know if it is possible to reduce the amount of chemotherapy by adding a more potent targeted treatment called Nilotinib, without increasing the risk of relapse.
(BASEC)
Intervention under investigation
Treatments studied: GRAALL-2014 protocol, including risk stratification, the introduction of Nelarabine in high-risk patients, and the use of Nilotinib in Philadelphia-positive ALL patients.
(BASEC)
Disease under investigation
Acute lymphoblastic leukemia (ALL) in young adults
(BASEC)
Patient inclusion criteria: Blood and bone marrow explorations completed before the pre-phase to corticosteroids Aged 18 to 59 years, with untreated B-cell ALL Karyotype showing no translocation t(9;22) and/or absence of the BCR-ABL gene in molecular biology (BASEC)
Exclusion criteria
Patient exclusion criteria: Lymphoblastic lymphoma with bone marrow blasts < 20%, Burkitt-type ALL or history of CML or other myeloproliferative neoplasia Contraindication to anthracyclines or any other intensive treatment Myocardial infarction within 6 months prior to inclusion, cardiomyopathy (NYHA class III or IV), LVEF < 50% and/or renal function < 30% (BASEC)
Trial sites
Aarau, Basel, Bellinzona, Bern, Freiburg, Geneva, Lausanne, Luzern, St. Gallen, Zurich
(BASEC)
Sponsor
Assistance Publique – Hôpitaux de Paris
(BASEC)
Contact
Contact Person Switzerland
Julia Decoudre
+41 31 389 91 91
trials@clutterswisscancerinstitute.chSwiss Cancer Institute
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
16.03.2016
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Protocol GRAALL-2014 Multicenter trial for the treatment of Acute Lymphoblastic Leukemia (ALL) in younger adults (18-59 years) - Comprising 3 sub-studies according to lineage (2 sub-substudies) GRAALL-2014/B & QUEST substudy Ph-negative B-lineage ALL GRAALL-2014/T & ATRIALL substudy T-ALL GRAAPH-2014 Ph+ ALL (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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