Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukaemia, Lymphoblastic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nelarabine | Drug | Nelarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Nelarabine
- description
- nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.
- interventionNames
- Drug: nelarabine
Primary outcomes (1)
- measure
- Neurological adverse events
- timeFrame
- Up to one year after treatment
Secondary outcomes (2)
- measure
- Other adverse events
- timeFrame
- Up to one year after treatment
- measure
- clinical response rate and survival
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available