Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL) Cancer Acute Lymphoblastic Leukaemia
Conditions
Interventions
No additional procedures are required in the trial. The trial drugs have already been used in previous paediatric oncology trials for many years.
Randomisation closed December 2007
Sponsors
Central Manchester University Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All children aged 1 - 18 years who have been previously diagnosed to have acute lymphoblastic leukaemia and have either relapsed after treatment or have primary refractory disease 2. For children who have relapsed, only those in whom this is the first relapse are eligible 3. Provide signed, written informed consent from parent and/or guardian 4. Protocol to have received national local ethical committee approval
Exclusion criteria
Exclusion criteria: 1. Children less than 1 year old and young adults of 18 years of age and older 2. Children in whom this is not the first relapse of their disease 3. Children with first relapse who have already received chemotherapy or radiotherapy prior to starting R3 4. Children with mature B cell ALL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added 13/05/2010: 1. Evaluate Progression Free Survival (PFS) by risk group 2. Evaluate whether a minimal residual disease level (MRD) level of 10-4 is a suitable criteria at the end of induction on which to decide whether chemotherapy or stem cell transplantation (SCT) will be most beneficial to patients in the intermediate risk group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 13/05/2010: 1. MRD as a surrogate marker for PFS 2. Randomised comparison between Mitoxantrone and Idarubicin | — |
Countries
Australia, Ireland, Netherlands, New Zealand, United Kingdom
Outcome results
None listed