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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Risk (HR) patients | Experimental | Nelarabine during consolidation and maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nelarabine | Drug | Nelarabine 1500 mg/m2/d (IV 2h) : D1, D3, D5 Cyclophosphamide 150 mg/m2/d (IV 3h) : D1, D3 etoposide (VP-16) 75 mg/m2/d (IV 1h) : D1, D3 granulocyte-colony stimulating factor 5 µg/kg/d (SC) : D7 until neutrophil >1 Giga/Liter for a maximum of 5 blocks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 4 years | |
| Cumulative incidence of relapse | 4 years | |
| Non relapse mortality (NRM) |
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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 ejection ventricle fraction (LEVF) < 50% and/or RF < 30%,
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
Other active malignancy
Pregnant (beta-Human Chorionic Gonadotropin (hCG) positive) or nursing woman
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
Treated with any other investigational agent or participation in another trial within 30 days prior to entering this study
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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| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology | 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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| ID | Term |
|---|---|
| C104457 | nelarabine |
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| 4 years |
| Disease free survival censored at allograft in first complete remission (CR) | 4 years |
| Cumulative incidence of relapse censored at allograft in first complete remission (CR) | 4 years |
| Overall survival censored at allograft in first complete remission (CR) | 4 years |
| Non relapse mortality (NRM) censored at allograft in first complete remission (CR) | 4 years |
| Minimal residual disease (MRD) | within 1 year |
| Proportion of patients having received the 5 cycles of nelarabine | 3 years |