Observational Study of Nelarabine in Children and Young Adults

A Multicentre, Single Arm, Observational Phase IV Study to Assess the Safety and Efficacy of Nelarabine in Children and Young Adults (up to 21 Years of Age) With Relapsed or Refractory T-Lineage Acute Lymphoblastic Leukaemia or Lymphoblastic Lymphoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00866671

Enrollment

Registered

2009-03-20

Start date

2009-02-28

Completion date

2014-09-30

Last updated

2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukaemia, Lymphoblastic, Acute

Keywords

T-ALL, Safety, Post Authorisation Safety Study, T-LBL, Lymphoblastic Lymphoma, Acute Lymphoblastic Leukemia

Brief summary

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).

Interventions

DRUGnelarabine

Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

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.

Design outcomes

Primary

Measure	Time frame
Neurological adverse events	Up to one year after treatment

Secondary

Measure	Time frame
Other adverse events	Up to one year after treatment
clinical response rate and survival	one year

Countries

Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Russia, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026