Observational Study of Nelarabine in Children and Young Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Leukaemia, Lymphoblastic, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nelarabine

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

nelarabine

Intervention Type DRUG

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

Interventions

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nelarabine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No