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The purpose of this study is to prospectively validate the new risk model, based on minimal residual disease (MRD) response level and oncogenetic status by comparing historical results of GRAALL-2005 with those of GRAALL-2014 in an identical population of patients (Philadelphia chromosome negative, B lineage ALL, aged 18 to 59 years old).
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| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of relapse (CIR) | 4 years | |
| non relapse mortality (NMR) | 4 years | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
With lymphoblastic lymphoma and bone marrow blasts < 20%, Burkitt-type ALL, or with antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm
With contra-indication to anthracyclines or any other general or visceral contra-indication to intensive therapy except if considered related to the ALL:
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%,
Active severe infection or known seropositivity for HIV or human T cell leukemia/lymphoma virus type 1 (HTLV1) or active hepatitis B or C
Pregnant (beta-Human Chorionic Gonadotropin positive) or nursing woman
Not able to bear with the procedures or the frequency of visits planned in the trial
Unable to consent, under tutelage or curators, or judiciary safeguard.
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Young Adults (age 18-59) with Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hervé Dombret, MDPhD | Contact | +33 (0)1 57 27 68 47 | herve.dombret@aphp.fr | |
| Véronique Lhéritier | Contact | +33(0)4 78 86 22 39 | veronique.lheritier@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Hervé Dombret, MDPhD | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hématologie Adulte, Saint Louis hospital | Recruiting | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41135009 | Derived | Boissel N, Chevret S, Huguet F, Leguay T, Hunault M, Graux C, Chalandon Y, Delabesse E, Hicheri Y, Chevallier P, Balsat M, Pastoret C, Escoffre-Barbe M, Pasquier F, Joris M, Thiebaut A, Huynh A, Dhedin N, Lemasle E, Bonmati C, Maury S, Guillerm G, Berceanu A, Manz M, Cluzeau T, Turlure P, Rousselot P, de Prijck B, Grardel N, Bene MC, Lafage-Pochitaloff M, Cuccuini W, Ifrah N, Lheritier V, Asnafi V, Clappier E, Dombret H. Age-adapted chemotherapy and MRD-oriented transplant for Ph-negative acute lymphoblastic leukemia: the GRAALL-2014 trial. Blood. 2026 Feb 19;147(8):821-833. doi: 10.1182/blood.2025029611. |
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leukemic cells, nucleic acids, serum
| 4 years |
| Cumulative incidence of relapse (CIR) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) | 4 years |
| overall survival after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) | 4 years |
| Non relapse mortality (NRM) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) | 4 years |
| Disease free survival (DFS) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) | 4 years |
| Minimal residual disease (MRD) | 1 year |