An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia

Phase 3

Completed

• Conditions: Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL); Cancer; Acute Lymphoblastic Leukaemia

• Registration Number: ISRCTN45724312
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust (UK)

Brief Summary

1. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/21131038 2. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25279465 3. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30826273

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-10-01
• Study Completion: 2011-12-31
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 480

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified