Treatment of Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia in Young Adults
Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years).
This study is testing a new way to predict treatment success for young adults with a specific type of leukemia to see if it can help them get better outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT02617004 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a new risk model for Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia (ALL) in young adults by comparing historical data from two cohorts, GRAALL-2005 and GRAALL-2014. It focuses on patients aged 18 to 59 years who have not been previously treated and have a specific genetic profile. The study will assess the relationship between minimal residual disease (MRD) response levels and oncogenetic status to improve treatment outcomes for this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 59 years with newly diagnosed Philadelphia Chromosome Negative B-lineage ALL and specific eligibility criteria.
Not a fit: Patients with other evolving cancers or those who have received prior treatment for ALL may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for young adults with Philadelphia Chromosome Negative B-cell ALL.
How similar studies have performed: Other studies have shown promise in validating risk models for ALL, suggesting that this approach may yield beneficial insights.
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 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.
Where this trial is running
Paris
- Hématologie Adulte, Saint Louis hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: Hervé Dombret, MDPhD — Aphp
- 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.