Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Observational Study of Nelarabine in Children and Young Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00866671
First received: March 19, 2009
Last updated: January 12, 2015
Last verified: January 2015

March 19, 2009
January 12, 2015
February 2009
September 2014   (final data collection date for primary outcome measure)
Neurological adverse events [ Time Frame: Up to one year after treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00866671 on ClinicalTrials.gov Archive Site
  • Other adverse events [ Time Frame: Up to one year after treatment ] [ Designated as safety issue: Yes ]
  • clinical response rate and survival [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Male or Female 21 years or younger with Relapsed or refractory T-lineage Acute Lymphoblastic Leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)

Leukaemia, Lymphoblastic, Acute
Drug: nelarabine
Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.
Nelarabine
nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.
Intervention: Drug: nelarabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Germany,   Israel,   Italy,   Netherlands,   Poland,   Russian Federation,   Spain
 
NCT00866671
111081
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP