Comparison of Imatinib Versus Dasatinib in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia
Summary
Imatinib 400mg daily is the current NICE-approved standard treatment for newly diagnosed Chronic Myeloid Leukaemia (CML). 5 yr follow up of CML patients treated in this way indicates an 89% probability of progression-free survival. Imatinib is not tolerated or effective in some patients however, and a proportion of patients become resistant to the drug. SPIRIT 2 study aims to establish whether a new drug, dasatinib, is superior to imatinib in terms of event free survival and therefore will be an effective first-line therapy for newly-diagnosed CML patients. This study will also provide crucial long-term survival, quality of life and health economic data to assist health care providers and managers to determine the most cost-effective drug therapy for CML.
Timeline
- Start
- 2008-08
- Primary completion
- 2018-03-07
- Completion
- 2018-03-07
Publications
- Neelakantan P, Gerrard G, Lucas C, Milojkovic D, May P, Wang L, Paliompeis C, Bua M, Reid A, Rezvani K, O'Brien S, Clark R, Goldman J, Marin D. Combining BCR-ABL1 transcript levels at 3 and 6 months in chronic myeloid leukemia: implications for early intervention strategies. Blood. 2013 Apr 4;121(14):2739-42. doi: 10.1182/blood-2012-11-466037. Epub 2013 Feb 4.
- Marin D, Hedgley C, Clark RE, Apperley J, Foroni L, Milojkovic D, Pocock C, Goldman JM, O'Brien S. Predictive value of early molecular response in patients with chronic myeloid leukemia treated with first-line dasatinib. Blood. 2012 Jul 12;120(2):291-4. doi: 10.1182/blood-2012-01-407486. Epub 2012 May 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Imatinib | Small molecule | 100 mg | Oral |
| Subject | dasatinib anhydrous | Small molecule | 100 mg | Oral |