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
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.
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 →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.
Exclusion Criteria:
With contra-indication to anthracyclines or any other general or visceral contra-indication to intensive therapy except if considered related to the ALL:
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
Disease free survival (DFS)
Time frame: 4 years
Overall survival
Time frame: 4 years
Cumulative incidence of relapse
Time frame: 4 years
Non relapse mortality (NRM)
Time frame: 4 years
Disease free survival censored at allograft in first complete remission (CR)
Time frame: 4 years
Cumulative incidence of relapse censored at allograft in first complete remission (CR)
Time frame: 4 years
Overall survival censored at allograft in first complete remission (CR)
Time frame: 4 years
Non relapse mortality (NRM) censored at allograft in first complete remission (CR)
Time frame: 4 years
Minimal residual disease (MRD)
Time frame: within 1 year
Proportion of patients having received the 5 cycles of nelarabine
Time frame: 3 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Precursor Cell Lymphoblastic Leukemia-Lymphoma→
Assistance Publique - Hôpitaux de Paris