Observational Study of Nelarabine in Children and Young Adults

Leukaemia, Lymphoblastic, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866671
• Other study ID #: 111081
• Status: Completed
• Phase: N/A
• First received: March 19, 2009
• Last updated: January 12, 2015
• Start date: February 2009
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Europe: European Medicines Agency
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukaemia, Lymphoblastic, Acute
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• nelarabine
Nelarabine is a prodrug of 9-ß-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.

Locations

Country	Name	City	State
Denmark	GSK Investigational Site	Aahur N
Denmark	GSK Investigational Site	Aalborg
Denmark	GSK Investigational Site	Koebenhavn Oe
Denmark	GSK Investigational Site	Odense C
France	GSK Investigational Site	Bordeaux cedex
France	GSK Investigational Site	Lille Cedex
France	GSK Investigational Site	Nantes Cedex 1
France	GSK Investigational Site	Paris Cedex 10
France	GSK Investigational Site	Paris cedex 12
France	GSK Investigational Site	Paris Cedex 19
France	GSK Investigational Site	Vandoeuvre-Les-Nancy
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Israel	GSK Investigational Site	Beer-Sheva
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Petach-Tikva
Israel	GSK Investigational Site	Ramat Gan
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Netherlands	GSK Investigational Site	Rotterdam
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wroclaw
Russian Federation	GSK Investigational Site	Krasnodar
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Boadilla del Monte (Madrid)
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Israel,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological adverse events		Up to one year after treatment	Yes
Secondary	Other adverse events		Up to one year after treatment	Yes
Secondary	clinical response rate and survival		one year	No