Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT02617004
Eligibility Criteria:
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
Exclusion Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT02617004
Study Brief:
Protocol Section:
NCT02617004