Observational Study of Nelarabine in Children and Young Adults

This study is currently recruiting participants.
Verified March 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00866671
First received: March 19, 2009
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention
Leukaemia, Lymphoblastic, Acute
Drug: nelarabine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Neurological adverse events [ Time Frame: Up to one year after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Nelarabine
nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.
Drug: nelarabine
Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866671

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Denmark
GSK Investigational Site Completed
Aahur N, Denmark
GSK Investigational Site Recruiting
Aalborg, Denmark, DK-9100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Koebenhavn Oe, Denmark, 2100
GSK Investigational Site Terminated
Odense C, Denmark
France
GSK Investigational Site Recruiting
Bordeaux cedex, France, 33076
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Lille Cedex, France, 59037
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Nantes Cedex 1, France, 44093
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Terminated
Paris Cedex 10, France, 75475
GSK Investigational Site Recruiting
Paris cedex 12, France, 75571
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Paris Cedex 19, France, 75935
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Vandoeuvre-Les-Nancy, France, 54511
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Germany
GSK Investigational Site Recruiting
Essen, Nordrhein-Westfalen, Germany, 45122
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hamburg, Germany, 20246
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Israel
GSK Investigational Site Terminated
Beer-Sheva, Israel, 84101
GSK Investigational Site Recruiting
Haifa, Israel, 31096
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Terminated
Petach-Tikva, Israel
GSK Investigational Site Recruiting
Ramat Gan, Israel, 52621
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Italy
GSK Investigational Site Terminated
Bologna, Emilia-Romagna, Italy, 40137
Netherlands
GSK Investigational Site Recruiting
Rotterdam, Netherlands, 3015 GJ
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Poland
GSK Investigational Site Completed
Bydgoszcz, Poland
GSK Investigational Site Completed
Lublin, Poland, 20-093
GSK Investigational Site Completed
Warszawa, Poland, 02-781
GSK Investigational Site Terminated
Warszawa, Poland, 00-576
GSK Investigational Site Completed
Wroclaw, Poland, 50-345
Russian Federation
GSK Investigational Site Recruiting
Krasnodar, Russian Federation, 350007
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Terminated
Moscow, Russian Federation, 119049
GSK Investigational Site Not yet recruiting
Moscow, Russian Federation, 117997
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Spain
GSK Investigational Site Terminated
Barcelona, Spain, 08035
GSK Investigational Site Terminated
Boadilla del Monte (Madrid), Spain, 28660
GSK Investigational Site Recruiting
Madrid, Spain, 28047
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Madrid, Spain, 28009
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00866671     History of Changes
Other Study ID Numbers: 111081
Study First Received: March 19, 2009
Last Updated: March 27, 2014
Health Authority: Europe: European Medicines Agency

Keywords provided by GlaxoSmithKline:
Safety
T-LBL
Lymphoblastic Lymphoma
Post Authorisation Safety Study
Acute Lymphoblastic Leukemia
T-ALL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2014