Text Size

Observational Study of Nelarabine in Children and Young Adults

This study is currently recruiting participants.
Verified April 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00866671
First received: March 19, 2009
Last updated: May 9, 2013
Last verified: April 2013
History of Changes
  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:

Drug Information available for: Nelarabine
U.S. FDA Resources

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 Not yet recruiting
Aahur N, Denmark
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
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 Not yet recruiting
Koebenhavn Oe, Denmark, 2100
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    
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 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 Not yet recruiting
Beer-Sheva, Israel, 84101
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
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 Not yet recruiting
Petach-Tikva, Israel
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
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 Not yet recruiting
Bologna, Emilia-Romagna, Italy, 40137
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    
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 Recruiting
Bydgoszcz, Poland
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
Lublin, Poland, 20-093
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
Warszawa, Poland, 02-781
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
Wroclaw, Poland, 50-345
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    
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 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 Not yet recruiting
Barcelona, Spain, 08035
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
Boadilla del Monte (Madrid), Spain, 28660
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    
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    
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: May 9, 2013
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 May 19, 2013