Observational Study of Nelarabine in Children and Young Adults
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | March 19, 2009 | ||||
Last Updated Date | August 9, 2012 | ||||
Start Date ICMJE | February 2009 | ||||
Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Neurological adverse events [ Time Frame: Up to one year after treatment ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00866671 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Observational Study of Nelarabine in Children and Young Adults | ||||
Official Title ICMJE | 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 | ||||
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). |
||||
Detailed Description | |||||
Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
Biospecimen | |||||
Sampling Method | Probability Sample | ||||
Study Population | Male or Female 21 years or younger with Relapsed or refractory T-lineage Acute Lymphoblastic Leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) |
||||
Condition ICMJE | Leukaemia, Lymphoblastic, Acute | ||||
Intervention ICMJE | Drug: nelarabine
Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue. |
||||
Study Group/Cohort (s) | Nelarabine
nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.
Intervention: Drug: nelarabine |
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 40 | ||||
Estimated Completion Date | April 2014 | ||||
Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | up to 21 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
|
||||
Location Countries ICMJE | Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Russian Federation, Spain | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00866671 | ||||
Other Study ID Numbers ICMJE | 111081 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | GlaxoSmithKline | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | GlaxoSmithKline | ||||
Verification Date | August 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |