Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
Cancer Research UK
Chief Investigator:
Prof Adele Fielding
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
A Phase 2 study for older adults with Acute Lymphoblastic Leukaemia
Design: UKALL60+ is a multicentre, non-randomised Phase II trial forolder patients with Acute Lymphoblastic Leukaemia (ALL). There are four treatment pathways based on standard practice here in the UK and in the Netherlands. Investigators together with their patients choose between these based on performance status, co-morbidities and personal preference. There is also a Registration pathway available for eligible patients not wishing to enroll in the main trial but consent to the collection of basic data regarding their treatment and outcome.
Treatment: Treatment for all pathways consists of Induction, Intensification (where applicable), Consolidation and Maintenance therapy during which combination chemotherapy is given for up to 2.5 years. For patient with Philadelphia chromosome positive disease the tyrosine kinase inhibitor imatinib is incorporated into the combination chemotherapy (Pathway A). Patients with Philadelphia chromosome negative ALL receive one of three treatment pathways; for patients perceived to have a good performance status and are willing to undergo intensive in-patient therapy during Induction local investigators and patients can choose between Intensive (Pathway B) and Intensive + (Pathway C). In the case of poor performance status and/or patient choice, a less intensive approach (Pathway D) is available. Patients registered to the Registration pathway (Pathway E) receive standard of care off trial. 
Key inclusion/exclusion criteria: Patients must be age ≥60 with ALL or ≥55 with ALL and not suitable for the UKALL14 trial. They must have newly diagnosed, previously untreated ALL. Patientsare not eligible if they have a known HIV infection, blast transformation of CML, mature B-cell leukaemia or be pregnant or lactating. 
Duration of recruitment: 6 years.
The overall aim of UKALL60+ is to document the safety, tolerability and feasibility of standard ‘backbone’ chemotherapeutic regimens for older patients with Acute Lymphoblastic Leukaemia (ALL). This trial will provided essential baseline data to inform the design of future phase II and III studies for older patients with ALL. 
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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