Actively Recruiting
Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
Led by Novartis Pharmaceuticals · Updated on 2026-04-29
6
Participants Needed
6
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase 1b, multicenter, open-label study aims to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of pelabresib as add-on to ruxolitinib in Japanese patients with myelofibrosis (MF).
CONDITIONS
Official Title
Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary myelofibrosis, post-polycythemia vera MF, or post-essential thrombocythemia MF according to 2022 International Consensus Classification
- DIPSS risk category intermediate-1, intermediate-2, or high risk at screening
- Currently treated with ruxolitinib monotherapy and expected to benefit from adding pelabresib
- Receiving stable dose of ruxolitinib (5 to 25 mg twice daily) for at least 8 weeks before first pelabresib dose
- Palpable spleen or documented splenomegaly by MRI or CT at screening
- Platelet count at least 100 x 10^9/L without growth factor support or platelet transfusions in the 4 weeks before first pelabresib dose
- Peripheral blood blasts less than 5%, assessed at screening
You will not qualify if you...
- Prior splenectomy at any time or splenic irradiation within 6 months
- Prior hematopoietic cell transplant or planned transplant within 24 weeks from first pelabresib dose
- Bone marrow blasts 5% or more if available at screening, or history of accelerated phase or leukemic transformation
- History of other malignancy except certain treated local skin cancers, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer under control, certain early-stage cancers in complete remission, or other cancers in remission for 3 or more years
- Received any approved or investigational agent for MF other than ruxolitinib within 14 days or 5 half-lives (whichever longer) before first pelabresib dose
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Novartis Investigative Site
Kamogawa, Chiba, Japan, 296-8602
Actively Recruiting
2
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0030006
Actively Recruiting
3
Novartis Investigative Site
Kamakura, Kanagawa, Japan, 247-8533
Actively Recruiting
4
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan, 1138431
Actively Recruiting
5
Novartis Investigative Site
Chūō, Yamanashi, Japan, 409-3898
Actively Recruiting
6
Novartis Investigative Site
Kumamoto, Japan, 862-8655
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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