Treatment for young adults with T-cell acute lymphoblastic leukemia
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
This study is testing if a new treatment plan using nelarabine can help young adults with T-cell acute lymphoblastic leukemia stay cancer-free longer than the usual treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 275 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT02619630 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of nelarabine-based consolidation and maintenance therapy in improving relapse-free survival for high-risk young adults aged 18-59 diagnosed with T-cell acute lymphoblastic leukemia (T-ALL). Participants must have completed necessary blood and bone marrow tests and have a performance status of less than 3. The study aims to determine if this treatment approach can lead to better outcomes compared to standard therapies.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 18-59 with newly diagnosed T-ALL and more than 20% bone marrow blasts.
Not a fit: Patients with lymphoblastic lymphoma, Burkitt-type ALL, or those with chronic myeloid leukemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for young adults with high-risk T-ALL.
How similar studies have performed: Other studies have shown promise with similar treatment approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hematology — Paris, France (Recruiting)
Study contacts
- Study coordinator: Hervé Dombret, MDPhD
- Email: herve.dombret@aphp.fr
- Phone: +33 (0)1 57 27 68 47
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.