18 and older, any sex, with Primary Myelofibrosis or Post-Polycythemia Vera-Myelofibrosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With at Least 50% Reduction in Spleen Length From Baseline at Week 24Primary· Baseline up to week 24
Percentage of participants achieving a 50% reduction in spleen length at week 24. For subjects with palpable spleen at baseline and non-palpable at post-baseline, the post-baseline spleen are imputed as 0. Subjects who had palpable, but missing spleen length at baseline is excluded from the analysis. Subjects with missing spleen length at Week 24 or who withdraw earlier from the study are considered as a non-responder. The 95% CI is computed using exact Clopper-Pearson method.
Group
Value
95% CI
All Subjects
56.0
41.3 – 70.0
Percentage of Participants With at Least 50% Reduction in Spleen Length From Baseline at Week 48Secondary· Baseline up to week 48
Percentage of participants achieving a 50% reduction in spleen length at week 48. For subjects with palpable spleen at baseline and non-palpable at post-baseline, the post-baseline spleen is imputed as 0. Subjects who had palpable, but missing spleen length at baseline is excluded from the analysis. Subjects with missing spleen length at Week 48 or who withdraw earlier from the study are considered as a non-responder. The 95% CI is computed using exact Clopper-Pearson method.
Group
Value
95% CI
All Subjects
36.0
22.9 – 50.8
Percentage of Participants by Spleen Length Reduction or no Increase From Baseline Category at Week 24 and Week 48Secondary· baseline, weeks 24 and 48
Participants who achieved a ≤ 50% reduction in spleen length at week 24 and 48 (reduction) and participants who had no increase greater than or equal to 50% (increase). The edge of the spleen shall be determined by palpation, measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion. For subjects with palpable spleen at baseline and non-palpable at post-baseline, the post-baseline spleen is imputed as 0.
Wk 24 ≤ -50% reduction n=43
Group
Value
95% CI
All Subjects
65.1
Wk 24 -50%, -25% reduction n=43
Group
Value
95% CI
All Subjects
11.6
Wk 24 -25%, -5% reduction n=43
Group
Value
95% CI
All Subjects
9.3
Wk 24 -5%, 5% reduction, increase n=43
Group
Value
95% CI
All Subjects
4.7
Wk 24 5%, 25% increase n=43
Group
Value
95% CI
All Subjects
9.3
Wk 24 25%, 50% increase n=43
Group
Value
95% CI
All Subjects
0
Wk 24 >50% increase n=43
Group
Value
95% CI
All Subjects
0
Wk 24 remained non-palpable n=43
Group
Value
95% CI
All Subjects
0
Percentage of Participants With at Least a 50% Reduction in Myelofibrosis 7 Item Symptom Scale (MF-7) and Myelofibrosis Symptom Assessment Form (MFSAF) at Week 24Secondary· Baseline and week 24
The MF-7 is a disease specific questionnaire comprised of 7 items that measures the severity of seven of the most prevalent associated symptoms including: tiredness, early satiety, abdominal discomfort, night sweats, itching (pruritus), bone pain (diffuse not joint or arthritis) and pain under ribs on left side. Each item was scored on a scale ranging from 0 (absent) to 10 (worst imaginable). The MF-7 score is computed as the sum of the observed scores in the individual items to achieve a 0 to 70 score. There would be one recall period of 24 hours used in this questionnaire. A separate questio
MF-7 Total Symptom score
Group
Value
95% CI
All Subjects
51.1
35.8 – 66.3
Modified MFSAF v2.0 Total symptom score
Group
Value
95% CI
All Subjects
55.6
40.0 – 70.4
Patient Global Impression of Change (PGIC) at Week 24 and Week 48Secondary· Baseline up to week 48
The PGIC is comprised of a single question intended to measure a subject's perspective of improvement or deterioration over time relative to treatment. The PGIC uses a seven-point scale where '1' equals very much improved and '7' equals very much worse.
Week 24 n=41 Very much improved
Group
Value
95% CI
All Subjects
5
Week 24 n=41 Much improved
Group
Value
95% CI
All Subjects
20
Week 24 n=41 Minimally improved
Group
Value
95% CI
All Subjects
9
Week 24 n=41 No change
Group
Value
95% CI
All Subjects
6
Week 24 n=41 Minimally worse
Group
Value
95% CI
All Subjects
1
Week 24 n=41 Much worse
Group
Value
95% CI
All Subjects
0
Week 24 n=41 Very much worse
Group
Value
95% CI
All Subjects
0
Week 48 n=33 Very much improved
Group
Value
95% CI
All Subjects
5
Percentage of Participants Transfusion Independency From Baseline up to Week 96Secondary· Baseline up to week 96
Percentage is based on number of subjects who are transfusion dependent at baseline. Transfusion dependence (TD) is defined as subjects receiving 6 or more units of transfusions 12 weeks prior to baseline. Transfusion independence (TI) rate is defined as subjects who are transfusion dependent at baseline and require no unit of transfusion for ≥ 12 weeks at any time during the study.
Transfusion response rate is defined as subjects who are TD at baseline and have 5 or less units of transfusion for ≥ 12 weeks at any time during the study.
Week 24 transfusion independent rate
Group
Value
95% CI
All Subjects
0
Week 24 transfusion responder rate
Group
Value
95% CI
All Subjects
44.4
Week 48 transfusion independent rate
Group
Value
95% CI
All Subjects
0
Week 48 transfusion responder rate
Group
Value
95% CI
All Subjects
66.7
Week 72 transfusion independent rate
Group
Value
95% CI
All Subjects
0
Week 72 transfusion responder rate
Group
Value
95% CI
All Subjects
66.7
Week 96 transfusion independent rate
Group
Value
95% CI
All Subjects
0
Week 96 transfusion responder rate
Group
Value
95% CI
All Subjects
66.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 100 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
All Patients
Serious: 17/51 (33%)
Deaths: 7/51
Serious adverse events (27 terms)
Reaction
System
All Patients
Anaemia
Blood and lymphatic system disorders
—
Cardiac failure
Cardiac disorders
—
Pneumonia
Infections and infestations
—
Haemolytic anaemia
Blood and lymphatic system disorders
—
Pancytopenia
Blood and lymphatic system disorders
—
Thrombocytopenia
Blood and lymphatic system disorders
—
Aortic valve disease
Cardiac disorders
—
Atrial fibrillation
Cardiac disorders
—
Cardiac failure acute
Cardiac disorders
—
Myocardial ischaemia
Cardiac disorders
—
Abdominal pain
Gastrointestinal disorders
—
Crohn's disease
Gastrointestinal disorders
—
Bile duct stone
Hepatobiliary disorders
—
Bronchitis
Infections and infestations
—
Escherichia sepsis
Infections and infestations
—
Escherichia urinary tract infection
Infections and infestations
—
Gastroenteritis
Infections and infestations
—
Lower respiratory tract infection bacterial
Infections and infestations
—
Respiratory syncytial virus bronchitis
Infections and infestations
—
Sepsis
Infections and infestations
—
Septic shock
Infections and infestations
—
Staphylococcal bacteraemia
Infections and infestations
—
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This was a study of treatment with ruxolitinib in patients who presented with transfusion dependent or independent anemia. Starting dose was 10 mg BID. This dose was maintained for the first 12 weeks of the study and up-titrated thereafter unless the subject met criteria for dose hold or dose reduction
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05621733 — A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea
· recruiting
NCT04551053 — To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Re
· Phase 3
· terminated
NCT04551066 — To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)
· Phase 3
· terminated
NCT04455841 — INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloprol
· Phase 1, PHASE2
· active not recruiting
NCT04530344 — Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
· Phase 3
· completed
Other recruiting trials for Primary Myelofibrosis
Currently open trials in the same condition.
NCT07228624 — Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplas
· Phase 2
· recruiting
NCT06661915 — A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)
· Phase 2
· recruiting
NCT06468033 — P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk
· Phase 3
· recruiting
NCT06517875 — Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
· Phase 2
· recruiting
NCT06343805 — A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF)
· Phase 1
· recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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· Phase 3
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· Phase 4
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· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
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NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 30 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02966353.