Adjunctive use of nilotinib in patient with imatinib resistant or intolerant chronic myeloid leukaemia (CML) undergoing a reduced intensity conditioned allogeneic transplant

Phase 1

Completed

• Conditions: Chronic myeloid leukaemia (CML); Cancer; Myeloid leukaemia

• Registration Number: ISRCTN12974558
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-30
• Study Completion: 2010-10-29
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified