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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 : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

November 25, 2015
November 30, 2015
December 8, 2017
February 2016
December 2020   (Final data collection date for primary outcome measure)
Disease free survival (DFS) [ Time Frame: 4 years ]
Same as current
Complete list of historical versions of study NCT02617004 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Multicenter Trial Treatment of Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia of Young Adults
Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years).
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).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
leukemic cells, nucleic acids, serum
Non-Probability Sample
Young Adults (age 18-59) with Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia
Philadelphia Chromosome Negative Adult B-cell Acute Lymphoblastic Leukemia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Same as current
December 2025
December 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 59 Years   (Adult)
No
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
 
 
NCT02617004
AOM12629_3
Yes
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Hervé Dombret, MDPhD APHP
Assistance Publique - Hôpitaux de Paris
December 2017