A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis (REFINE)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507276-53-00

Acronym

M16-109

Enrollment

Registered

2024-04-24

Start date

2020-03-23

Completion date

2025-01-28

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis

Brief summary

≥ 35% spleen volume reduction from baseline (SVR35) at Week 24 measured by MRI/CT.

Detailed description

The secondary endpoints are at least 50% reduction in total symptom score from baseline measured by MFSAF 4.0; anemia response; and change in grade of bone marrow fibrosis.

Interventions

DRUGNavitoclax

DRUGRUXOLITINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
≥ 35% spleen volume reduction from baseline (SVR35) at Week 24 measured by MRI/CT.	—

Secondary

Measure	Time frame
The secondary endpoints are at least 50% reduction in total symptom score from baseline measured by MFSAF 4.0; anemia response; and change in grade of bone marrow fibrosis.	—

Countries

Croatia, Greece, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026