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
N/A
N/A
21 Years
N/A
21 Years
Open (Enrolling)
Both
Leukaemia, Lymphoblastic, Acute
Both
Leukaemia, Lymphoblastic, Acute
Trial Information
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
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Neurological adverse events
Outcome Time Frame:
Up to one year after treatment
Safety Issue:
Yes
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Europe: European Medicines Agency
Study ID:
111081
NCT ID:
NCT00866671
Start Date:
February 2009
Completion Date:
April 2014
Related Keywords:
- Leukaemia, Lymphoblastic, Acute
- Safety
- T-LBL
- Lymphoblastic Lymphoma
- Post Authorisation Safety Study
- Acute Lymphoblastic Leukemia
- T-ALL
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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