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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 : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
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).

Condition or disease
Philadelphia Chromosome Negative Adult B-cell Acute Lymphoblastic Leukemia

Study Design
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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

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Cumulative incidence of relapse (CIR) [ Time Frame: 4 years ]
  2. non relapse mortality (NMR) [ Time Frame: 4 years ]
  3. Overall survival [ Time Frame: 4 years ]
  4. Cumulative incidence of relapse (CIR) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
  5. overall survival after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
  6. Non relapse mortality (NRM) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
  7. Disease free survival (DFS) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR) [ Time Frame: 4 years ]
  8. Minimal residual disease (MRD) [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
leukemic cells, nucleic acids, serum

Eligibility Criteria
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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
Study Population
Young Adults (age 18-59) with Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia
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.
Contacts and Locations
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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


Contacts
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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

Locations
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France
Hématologie Adulte, Saint Louis hospital Recruiting
Paris, France, 75010
Contact: Hervé Dombret    +33 (0)1 57 27 68 47    herve.dombret@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Hervé Dombret, MDPhD APHP
More Information
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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
Additional relevant MeSH terms:
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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