CML, Chronic Phase Clinical Trial
Official title:
Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study
To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.
To determine:
- Duration of response
- Progression free survival
- Proportion of responders 2 years after discontinuation of inecalcitol
- Duration of response after discontinuation of inecalcitol and imatinib
- Bone remodelling effect
- Safety of inecalcitol in combination with imatinib
- Quality of Life
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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