NCT02949570

Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study

Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Hybrigenics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.

Detailed description

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

Conditions

• CML, Chronic Phase

Interventions

Type	Name	Description
DRUG	Inecalcitol	Prospective open label, non-comparative, multicentre exploratory study. Divided in 2 parts Part1: Inecalcitol treatment will be added to imatinib for 12 months. Part 2: Follow-up after discontinuation of inecalcitol. Imatinib will be maintained for 2 years and then will be stopped for those still in MR4.5. These patients will then be followed for 2 additional years after discontinuation of imatinib.

Timeline

• Start date: 2014-02-01
• Primary completion: 2018-02-01
• Completion: 2018-04-01
• First posted: 2016-10-31
• Last updated: 2016-10-31

Locations

1 site across 1 country: France