A Phase 2 study for older adults with Acute Lymphoblastic Leukaemia
Completed
- Conditions
- Acute Lymphoblastic Leukaemia (ALL)10024324
- Registration Number
- NL-OMON41230
- Lead Sponsor
- Cancer Research UK & UCL Cancer Trials Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
• Age >= 60 with Acute Lymphoblastic Leukaemia (ALL) OR >= 55 with Acute Lymphoblastic Leukaemia (ALL) unsuitable for the UKALL14 or HOVON 100 trial
• Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5-7 days may be given before study registration)
• Written informed consent
Exclusion Criteria
• Known HIV infection
• Blast transformation of CML
• Mature B-cell leukemia i.e. Burkitt*s disease t(8,14)(q24;q32) and variant c-myc translocations e.g. t(2;8)(p12;q24),t(8;22)(q24;q11)
• Women who are pregnant or lactating
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Complete remission rate after 2 phases of induction</p><br>
- Secondary Outcome Measures
Name Time Method <p>* EFS at 1 year<br /><br>* Treatment related mortality<br /><br>* Complete remission rate after 1 phase of induction<br /><br>* Prognostic significance of molecularly determined minimal residual disease<br /><br>(MRD) at various timepoints during therapy with respect to relapse<br /><br>occurrence.<br /><br>* Overall Survival at 1 year<br /><br>* Tolerability of treatment as determined by occurrence of key adverse effects<br /><br>* Duration of in-patient hospitalisation<br /><br>* Relationship between performance status/comorbidity and treatment option<br /><br>chosen<br /><br>* Quality of life aspects assessed at diagnosis/baseline at various time<br /><br>points.</p><br>