Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old)

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 1, 2015

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for young adults aged 18 to 59 who have been diagnosed with a type of blood cancer called T-cell Acute Lymphoblastic Leukemia (T-ALL). The study aims to evaluate how effective a specific treatment plan, which includes a medication called nelarabine, is in preventing the cancer from coming back after initial treatment. This is particularly focused on patients who are considered high-risk for relapse.

To participate in this trial, individuals must have a confirmed diagnosis of T-ALL with more than 20% cancer cells in their bone marrow and must have undergone certain preliminary tests. They should not have received prior treatment for this cancer and must be in reasonably good health. Participants will receive the new treatment and will be monitored closely throughout the study for their health and response to the therapy. It’s important for potential participants to understand that they will need to sign a consent form and may be required to use effective contraception if they are of childbearing age. This trial is currently recruiting participants, so those who meet the criteria and are interested can discuss it with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Whose blood and bone marrow explorations have been completed before the steroids prephase
• • 2. aged 18-59 years old with a not previously treated (including IT injection) T-ALL newly-diagnosed according to the WHO 2008 definition with \> 20% bone marrow blasts
• • 3. With Eastern Cooperative Oncology Group (ECOG) performance status \< 3
• • 4. With or without central nervous system (CNS) involvement or testis
• • 5. Without other evolving cancer (except basal cell carcinoma of the skin and "in situ" carcinoma of the cervix) or its chemo or radio-therapy treatment finished at least since 6 months
• • 6. Having signed a written informed consent
• • 7. With efficient contraception for women of childbearing age (excluding estrogens and IUD)
• • 8. Having received or being receiving steroid prephase
• • 9. With health insurance coverage
• 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 \> 1.5 x 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 ejection ventricle fraction (LEVF) \< 50% and/or RF \< 30%,
• • 4. Active severe infection or known seropositivity for HIV or Human T cell leukemia/lymphoma virus type 1 (HTLV-1) or active hepatitis B or C
• • 5. Other active malignancy
• • 6. Pregnant (beta-Human Chorionic Gonadotropin (hCG) positive) or nursing woman
• • 7. Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least three months thereafter. Patients not willing to ensure not to beget a child during participation in the study and at least three months thereafter
• • 8. Treated with any other investigational agent or participation in another trial within 30 days prior to entering this study
• • 9. Not able to bear with the procedures or the frequency of visits planned in the trial
• • 10. Unable to consent, under tutelage or curators, or judiciary safeguard