Observational Study of Nelarabine in Children and Young Adults

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Leukaemia, Lymphoblastic, Acute

Treatments: Drug: nelarabine

Study type: Observational

Funder types: Industry

Identifiers

NCT00866671

111081

Details and patient eligibility

About

This international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It is a post-authorisation safety study (PASS) conducted for the purpose of confirming the safety profile and the clinical benefit of nelarabine under licensed conditions of use. The study is observational, non-interventional, and will include approximately 40 children and young adults (up to 21 years of age).

Enrollment: 28 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≤ 21 years of age
• Relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
• Prior treatment with at least two chemotherapy regimens
• Selected for treatment with nelarabine

Exclusion criteria

• Known hypersensitivity to the active substance.
• Women of childbearing potential who are unable or unwilling to use adequate contraceptive measures
• Males with partners of child bearing potential who are not willing to use condoms or abstinence
• Patients with persistent neurological toxicity (CTC grade > = grade 2)
• Adolescents (aged 16 years and over) and adults for whom the physician prescribes the 1500mg/m2 dose of nelarabine.

Trial design

28 participants in 1 patient group

Nelarabine

Description:

nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.

Treatment:

Drug: nelarabine