Informations générales (source: ClinicalTrials.gov)
Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years). (GRAALL-2014/B)
Observational
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2016
décembre 2025
29 juin 2024
The purpose of this study is to prospectively validate the new risk model, based on
minimal residual disease (MRD) response level and oncogenetic status by comparing
historical results of GRAALL-2005 with those of GRAALL-2014 in an identical population of
patients (Philadelphia chromosome negative, B lineage ALL, aged 18 to 59 years old).
Etablissements
Critères
Tous
Inclusion Criteria:
1. Whose blood and bone marrow explorations have been completed before the steroids
prephase
2. Aged 18 to 59 years old with not previously treated (including intrathecal
injection) B-lineage-ALL newly diagnosed according to the WHO 2008 definition with ≥
20% bone marrow blasts
3. Whose karyotype shows no t(9;22) and/or the absence in molecular biology of
breakpoint cluster region-Abelson (BCR-ABL)
4. With Eastern Cooperative Oncology Group (ECOG) performance status ≤3
5. With or without central nervous system (CNS) or testis involvement
6. Without other evolving cancer (except basal cell carcinoma of the skin or "in situ"
carcinoma of the cervix) or its radiotherapy or chemotherapy treatment should be
finished at least since 6 months
7. Having signed a written informed consent
8. With efficient contraception for women of childbearing age (excluding estrogens and
IUD)
9. With health insurance coverage
10. Who have received or being receiving the steroid prephase
1. Whose blood and bone marrow explorations have been completed before the steroids
prephase
2. Aged 18 to 59 years old with not previously treated (including intrathecal
injection) B-lineage-ALL newly diagnosed according to the WHO 2008 definition with ≥
20% bone marrow blasts
3. Whose karyotype shows no t(9;22) and/or the absence in molecular biology of
breakpoint cluster region-Abelson (BCR-ABL)
4. With Eastern Cooperative Oncology Group (ECOG) performance status ≤3
5. With or without central nervous system (CNS) or testis involvement
6. Without other evolving cancer (except basal cell carcinoma of the skin or "in situ"
carcinoma of the cervix) or its radiotherapy or chemotherapy treatment should be
finished at least since 6 months
7. Having signed a written informed consent
8. With efficient contraception for women of childbearing age (excluding estrogens and
IUD)
9. With health insurance coverage
10. Who have received or being receiving the steroid prephase
1. With lymphoblastic lymphoma and bone marrow blasts < 20%, Burkitt-type ALL, or with
antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm
2. With contra-indication to anthracyclines or any other general or visceral
contra-indication to intensive therapy except if considered related to the ALL:
- Aspartate transaminase (AST) and/or alanine transaminase (ALT) > 5 x upper
limit of normal range (ULN)
- Total bilirubin ≥ 2.5 x upper limit of normal range (ULN)
- Creatinine >1.5x upper limit of normal range (ULN) or creatinine clearance <50
mL/mn
3. Myocardial infarction within 6 months prior to inclusion in the trial,
cardiomyopathy (NYHA grade III or IV), left ventricle ejection fraction (LVEF) < 50%
and or Shortening fraction < 30%,
4. Active severe infection or known seropositivity for HIV or human T cell
leukemia/lymphoma virus type 1 (HTLV1) or active hepatitis B or C
5. Pregnant (beta-Human Chorionic Gonadotropin positive) or nursing woman
6. Not able to bear with the procedures or the frequency of visits planned in the trial
7. Unable to consent, under tutelage or curators, or judiciary safeguard.