Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old)
GRAALL-2014/T
1 other identifier
interventional
275
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2015
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 21, 2019
February 1, 2019
5 years
November 25, 2015
October 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Disease free survival (DFS)
4 years
Secondary Outcomes (9)
Overall survival
4 years
Cumulative incidence of relapse
4 years
Non relapse mortality (NRM)
4 years
Disease free survival censored at allograft in first complete remission (CR)
4 years
Cumulative incidence of relapse censored at allograft in first complete remission (CR)
4 years
- +4 more secondary outcomes
Study Arms (1)
High-Risk (HR) patients
EXPERIMENTALNelarabine during consolidation and maintenance
Interventions
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
Eligibility Criteria
You may qualify if:
- Whose blood and bone marrow explorations have been completed before the steroids prephase
- 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
- With Eastern Cooperative Oncology Group (ECOG) performance status \< 3
- With or without central nervous system (CNS) involvement or testis
- 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
- Having signed a written informed consent
- With efficient contraception for women of childbearing age (excluding estrogens and IUD)
- Having received or being receiving steroid prephase
- With health insurance coverage
You may not qualify if:
- With lymphoblastic lymphoma and bone marrow blasts \< 20%, Burkitt-type ALL or with antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm
- 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
- 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
- Other active malignancy
- Pregnant (beta-Human Chorionic Gonadotropin (hCG) positive) or nursing woman
- 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
- Treated with any other investigational agent or participation in another trial within 30 days prior to entering this study
- Not able to bear with the procedures or the frequency of visits planned in the trial
- Unable to consent, under tutelage or curators, or judiciary safeguard
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hematology
Paris, 75010, France
Related Publications (1)
Boissel N, Chevret S, Rigal-Huguet F, Leguay TT, Hunault M, Graux C, Chalandon Y, Delabesse E, Hicheri Y, Chevallier P, Balsat M, Pastoret C, Escoffre-Barbe M, Pasquier F, Joris M, Thiebaut A, Huynh A, Dhedin N, Lemasle E, Bonmati C, Maury S, Guillerm G, Berceanu A, Schanz U, Cluzeau T, Turlure P, Rousselot P, De Prijck B, Grardel N, Bene MC, Lafage-Pochitaloff M, Cuccuini W, Ifrah NH, Lheritier V, Asnafi V, Clappier E, Dombret H. Age-adapted chemotherapy and MRD-oriented transplant for Ph-negative acute lymphoblastic leukemia: the GRAALL-2014 trial. Blood. 2025 Oct 24:blood.2025029611. doi: 10.1182/blood.2025029611. Online ahead of print.
PMID: 41135009DERIVED
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2015
First Posted
December 2, 2015
Study Start
December 1, 2015
Primary Completion
December 1, 2020
Study Completion
December 1, 2025
Last Updated
October 21, 2019
Record last verified: 2019-02