Chronic myeloid leukaemia (CML) Cancer Myeloid leukaemia
Conditions
Interventions
Nilotinib will be commenced on day +35 post-transplant. Nilotinib will be commenced at a dose of 200 mg daily (orally) for two weeks and if this is tolerated, it will be increased to 200 mg twice dail
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. BCR/ABL positive CML in first chronic phase 2. Resistant or intolerant to imatinib mesylate 3. Aged greater than 18 years, either sex 4. Patients with a human leukocyte antigen (HLA) identical sibling donor or a suitable matched unrelated donor 5. Patients considered fit for transplantation 6. Patients must be able to swallow capsules 7. Liver function less than 2.5 upper limit of normal 8. In patients with magnesium and potassium levels below the lower limit of normal (LLN), every attempt should be made to normalise levels 9. All men and women of child bearing potential must agree to practice effective contraception during the entire study period 10. CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition or imatinib-resistance or intolerance are eligible 11. Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice 12. Be willing and able to comply with the protocol for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Patients with an allergy to fludarabine, busulphan, campath or nilotinib 2. BCR/ABL negative CML 3. Pregnant or lactating women 4. Patients with organ allografts 5. Impaired cardiac function 6. Patients with any other condition, which in the Investigator's opinion would not make the patient a good candidate for the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of nilotinib therapy. Adverse events and therapy-related side effects will be monitored continuously during nilotinib treatment and until 28 days after the last dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Relapse rate, assessed at 12 months post-transplant 2. Survival, assessed annually until 3 years post-transplant | — |
Countries
United Kingdom
Outcome results
None listed