Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old)
NCT02619630 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 275
Last updated 2019-10-21
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.
Conditions
- T-cell Adult Acute Lymphoblastic Leukemia
Interventions
- 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
Sponsors & Collaborators
-
Assistance Publique - Hôpitaux de Paris
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 59 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2020-12-31
- Completion
- 2025-12-31
Countries
- France
Study Locations
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