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RecruitingNCT02619630GRAALL-2014/TUpdated Oct 21, 2019

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

A Phase 2 interventional study of nelarabine in T-cell Adult Acute Lymphoblastic Leukemia, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2019-10-21.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2020, 5 years 10 months ago, but the record still lists the study as recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
275
Allocation
Not applicable
Ages
18 Years to 59 Years
Sex
All
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Study 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.

02

Conditions studied

  • T-cell Adult Acute Lymphoblastic Leukemia
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In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.

This study's planned enrollment of 275 is above the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
275 participants (estimated)

Study arms

  • Experimental
    High-Risk (HR) patients

    Nelarabine during consolidation and maintenance

    Drug: nelarabine

Interventions

  • Drugnelarabine

    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

06

What researchers measure

Primary outcomes

  1. Disease free survival (DFS)

    Time frame: 4 years

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02619630
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Dec 2, 2015
Start date
Dec 2015
Primary completion
Dec 2020 (estimated)
Completion
Dec 2025 (estimated)
Last update
Oct 21, 2019

Study contacts

Hervé Dombret, MDPhD
Contact
herve.dombret@aphp.fr
+33 (0)1 57 27 68 47
Véronique Lhéritier
Contact
veronique.lheritier@chu-lyon.fr
+33(0)4 78 86 22 39

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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