NCT02619630

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 275 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-12-01
• Completion: 2025-12-01
• First posted: 2015-12-02
• Last updated: 2019-10-21

Locations

1 site across 1 country: France