Clinical trial NCT02619630: Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old)
Official title: Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old): Evaluating the Efficacy of a Nelarabine Based Consolidation and Maintenance in High-risk Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: T-cell Adult Acute Lymphoblastic Leukemia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of nelarabine-based consolidation and maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients.


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

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: 4 years
Secondary outcomes:
measure: Overall survival
timeFrame: 4 years
measure: Cumulative incidence of relapse
timeFrame: 4 years
measure: Non relapse mortality (NRM)
timeFrame: 4 years
measure: Disease free survival censored at allograft in first complete remission (CR)
timeFrame: 4 years
measure: Cumulative incidence of relapse censored at allograft in first complete remission (CR)
timeFrame: 4 years
measure: Overall survival censored at allograft in first complete remission (CR)
timeFrame: 4 years
measure: Non relapse mortality (NRM) censored at allograft in first complete remission (CR)
timeFrame: 4 years
measure: Minimal residual disease (MRD)
timeFrame: within 1 year
measure: Proportion of patients having received the 5 cycles of nelarabine
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hematology
Study officials:
References: