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Trial record 74 of 170 for:    "Acute Lymphocytic Leukemia" | "Etoposide"

Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old) (GRAALL-2014/T)

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ClinicalTrials.gov Identifier: NCT02619630
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
T-cell Adult Acute Lymphoblastic Leukemia Drug: nelarabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old): Evaluating the Efficacy of a Nelarabine Based Consolidation and Maintenance in High-risk Patients
Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Nelarabine

Arm Intervention/treatment
Experimental: High-Risk (HR) patients
Nelarabine during consolidation and maintenance
Drug: nelarabine

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





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

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]
  2. Cumulative incidence of relapse [ Time Frame: 4 years ]
  3. Non relapse mortality (NRM) [ Time Frame: 4 years ]
  4. Disease free survival censored at allograft in first complete remission (CR) [ Time Frame: 4 years ]
  5. Cumulative incidence of relapse censored at allograft in first complete remission (CR) [ Time Frame: 4 years ]
  6. Overall survival censored at allograft in first complete remission (CR) [ Time Frame: 4 years ]
  7. Non relapse mortality (NRM) censored at allograft in first complete remission (CR) [ Time Frame: 4 years ]
  8. Minimal residual disease (MRD) [ Time Frame: within 1 year ]
  9. Proportion of patients having received the 5 cycles of nelarabine [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Whose blood and bone marrow explorations have been completed before the steroids prephase
  2. aged 18-59 years old with a not previously treated (including IT injection) T-ALL newly-diagnosed according to the WHO 2008 definition with > 20% bone marrow blasts
  3. With Eastern Cooperative Oncology Group (ECOG) performance status < 3
  4. With or without central nervous system (CNS) involvement or testis
  5. Without other evolving cancer (except basal cell carcinoma of the skin and "in situ" carcinoma of the cervix) or its chemo or radio-therapy treatment finished at least since 6 months
  6. Having signed a written informed consent
  7. With efficient contraception for women of childbearing age (excluding estrogens and IUD)
  8. Having received or being receiving steroid prephase
  9. With health insurance coverage

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 > 1.5 x 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 ejection ventricle fraction (LEVF) < 50% and/or RF < 30%,
  4. 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
  5. Other active malignancy
  6. Pregnant (beta-Human Chorionic Gonadotropin (hCG) positive) or nursing woman
  7. 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
  8. Treated with any other investigational agent or participation in another trial within 30 days prior to entering this study
  9. Not able to bear with the procedures or the frequency of visits planned in the trial
  10. Unable to consent, under tutelage or curators, or judiciary safeguard

Information from the National Library of Medicine

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): NCT02619630


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
Hematology Recruiting
Paris, France, 75010
Contact: Hervé Dombret, MDPhD       herve.dombret@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02619630     History of Changes
Other Study ID Numbers: AOM12629_2
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases