Last updated: 11/03/2018 11:23:39
Observational study of nelarabine in children and young adults
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Neurological adverse events
Timeframe: Up to one year after treatment
Secondary outcomes:
Other adverse events
Timeframe: Up to one year after treatment
clinical response rate and survival
Timeframe: one year
Interventions:
Enrollment:
28
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Leukaemia, Lymphoblastic, Acute
Product
nelarabine
Collaborators
Not applicable
Study date(s)
February 2009 to September 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable - 21 years
Accepts healthy volunteers
No
- ≤ 21 years of age
- Relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
- Known hypersensitivity to the active substance.
- Women of childbearing potential who are unable or unwilling to use adequate contraceptive measures
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Boadilla del Monte (Madrid), Spain, 28660
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40137
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2014-22-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website