Multicenter Trial Treatment of Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia of Young Adults (GRAALL-2014/B)
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ClinicalTrials.gov Identifier: NCT02617004 |
Recruitment Status :
Recruiting
First Posted : November 30, 2015
Last Update Posted : February 19, 2019
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Condition or disease |
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Philadelphia Chromosome Negative Adult B-cell Acute Lymphoblastic Leukemia |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years). |
Study Start Date : | February 2016 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2025 |

- Disease free survival (DFS) [ Time Frame: 4 years ]
- Cumulative incidence of relapse (CIR) [ Time Frame: 4 years ]
- non relapse mortality (NMR) [ Time Frame: 4 years ]
- Overall survival [ Time Frame: 4 years ]
- Cumulative incidence of relapse (CIR) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
- overall survival after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
- Non relapse mortality (NRM) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
- Disease free survival (DFS) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
- Minimal residual disease (MRD) [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Whose blood and bone marrow explorations have been completed before the steroids prephase
- 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
- Whose karyotype shows no t(9;22) and/or the absence in molecular biology of breakpoint cluster region-Abelson (BCR-ABL)
- With Eastern Cooperative Oncology Group (ECOG) performance status ≤3
- With or without central nervous system (CNS) or testis involvement
- 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
- Having signed a written informed consent
- With efficient contraception for women of childbearing age (excluding estrogens and IUD)
- With health insurance coverage
- Who have received or being receiving the steroid prephase
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
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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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617004
Contact: Hervé Dombret, MDPhD | +33 (0)1 57 27 68 47 | herve.dombret@aphp.fr | |
Contact: Véronique Lhéritier | +33(0)4 78 86 22 39 | veronique.lheritier@chu-lyon.fr |
France | |
Hématologie Adulte, Saint Louis hospital | Recruiting |
Paris, France, 75010 | |
Contact: Hervé Dombret +33 (0)1 57 27 68 47 herve.dombret@aphp.fr |
Principal Investigator: | Hervé Dombret, MDPhD | APHP |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT02617004 |
Other Study ID Numbers: |
AOM12629_3 |
First Posted: | November 30, 2015 Key Record Dates |
Last Update Posted: | February 19, 2019 |
Last Verified: | February 2019 |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Translocation, Genetic Chromosome Aberrations Pathologic Processes |