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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

Tracking Information
First Submitted Date November 25, 2015
First Posted Date November 30, 2015
Last Update Posted Date February 19, 2019
Study Start Date February 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 27, 2015)
Disease free survival (DFS) [ Time Frame: 4 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 27, 2015)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multicenter Trial Treatment of Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia of Young Adults
Official Title Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years).
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
leukemic cells, nucleic acids, serum
Sampling Method Non-Probability Sample
Study Population Young Adults (age 18-59) with Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia
Condition Philadelphia Chromosome Negative Adult B-cell Acute Lymphoblastic Leukemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 27, 2015)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02617004
Other Study ID Numbers AOM12629_3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Hervé Dombret, MDPhD APHP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2019