NCT00981799

Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL

A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL and POETIC

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Therapeutic Advances in Childhood Leukemia Consortium · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.

Conditions

• Relapsed T-Cell Acute Lymphoblastic Leukemia
• Relapsed T-Cell Lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	Nelarabine	Dose will be assigned at study entry. Nelarabine will be given IV over 60 minutes (given at hours 0 to 1) on days 1 through 5.
DRUG	Etoposide	100 mg/m2/day IV over 2 hours (given at hours 1 to 3) on days 1 through 5
DRUG	Cyclophosphamide	Dose will be assigned at study entry, IV as a 30-60 minute infusion (given at hours 3 to 4) on days 1 through 5.
DRUG	Methotrexate	Give between day 29 and 36 or when ANC\>750 and PLTS\>75,000 - whichever comes first (but not prior to day 22) at the dose defined by age below, ideally in conjunction with BM evaluation. Given intrathecally at the dose defined by age below. 8 mg for patients age greater than or equal to 1, but \<2 years of age 10 mg for patients age greater than or equal to 2, but \<3 years of age 12 mg for patients greater than or equal to 3, but \< 9 years of age 15 mg for patients greater than or equal to \>9 years of age
DRUG	Filgrastim	5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is \> 1000/mm3 for two consecutive days.

Timeline

• Start date: 2010-06-01
• Primary completion: 2015-11-01
• Completion: 2016-07-18
• First posted: 2009-09-22
• Last updated: 2020-10-01
• Results posted: 2020-10-01

Locations

37 sites across 7 countries: United States, Australia, Austria, Canada, France, Italy, Netherlands