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
  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 ]

Enrollment: 28
Study Start Date: February 2009
Study Completion Date: September 2014
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
GSK Investigational Site
Aahur N, Denmark
GSK Investigational Site
Aalborg, Denmark, DK-9100
GSK Investigational Site
Koebenhavn Oe, Denmark, 2100
GSK Investigational Site
Odense C, Denmark
France
GSK Investigational Site
Bordeaux cedex, France, 33076
GSK Investigational Site
Lille Cedex, France, 59037
GSK Investigational Site
Nantes Cedex 1, France, 44093
GSK Investigational Site
Paris Cedex 10, France, 75475
GSK Investigational Site
Paris cedex 12, France, 75571
GSK Investigational Site
Paris Cedex 19, France, 75935
GSK Investigational Site
Vandoeuvre-Les-Nancy, France, 54511
Germany
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
GSK Investigational Site
Hamburg, Germany, 20246
Israel
GSK Investigational Site
Beer-Sheva, Israel, 84101
GSK Investigational Site
Haifa, Israel, 31096
GSK Investigational Site
Petach-Tikva, Israel
GSK Investigational Site
Ramat Gan, Israel, 52621
Italy
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40137
Netherlands
GSK Investigational Site
Rotterdam, Netherlands, 3015 GJ
Poland
GSK Investigational Site
Bydgoszcz, Poland
GSK Investigational Site
Lublin, Poland, 20-093
GSK Investigational Site
Warszawa, Poland, 02-781
GSK Investigational Site
Warszawa, Poland, 00-576
GSK Investigational Site
Wroclaw, Poland, 50-345
Russian Federation
GSK Investigational Site
Krasnodar, Russian Federation, 350007
GSK Investigational Site
Moscow, Russian Federation, 117997
GSK Investigational Site
Moscow, Russian Federation, 119049
Spain
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Boadilla del Monte (Madrid), Spain, 28660
GSK Investigational Site
Madrid, Spain, 28009
GSK Investigational Site
Madrid, Spain, 28047
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: January 12, 2015
Health Authority: Europe: European Medicines Agency

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

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

ClinicalTrials.gov processed this record on April 23, 2015