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JAK2 Inhibitor

FEDRATINIB for Primary Myelofibrosis (FREEDOM Trial)

Phase 3
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at screening, cycle 1, 2, 3, 6, 9, 15, 18, 21, 24, 27, 30 and end of treatment (an average of 50.3 weeks up to a maximum of 124 weeks)
Awards & highlights

FREEDOM Trial Summary

This trial is a study to see if a drug called fedratinib is effective and safe in people with a certain type of bone marrow cancer.

Eligible Conditions
  • Primary Myelofibrosis
  • Myelofibrosis

FREEDOM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at screening, cycle 1, 2, 3, 6, 9, 15, 18, 21, 24, 27, 30 and end of treatment (an average of 50.3 weeks up to a maximum of 124 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening, cycle 1, 2, 3, 6, 9, 15, 18, 21, 24, 27, 30 and end of treatment (an average of 50.3 weeks up to a maximum of 124 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Have a ≥ 35% Spleen Volume Reduction (SVR) at End of Cycle 6
Secondary outcome measures
Durability of Spleen Response by Palpation (DRP)
Durability of Spleen Volume Response by MRI/CT (DR)
Durability of Symptom Response (DSR)
+13 more

Side effects data

From 2023 Phase 3 trial • 38 Patients • NCT03755518
58%
Anaemia
50%
Constipation
39%
Diarrhoea
39%
Nausea
39%
Blood creatinine increased
34%
Thrombocytopenia
29%
Fatigue
26%
Dyspnoea
24%
Dizziness
24%
Pruritus
24%
Cough
21%
Oedema peripheral
18%
Vomiting
18%
Insomnia
18%
Decreased appetite
18%
Hyperuricaemia
16%
Vitamin B1 decreased
16%
Hyperkalaemia
16%
Pain in extremity
16%
Abdominal pain
16%
Arthralgia
11%
Neutropenia
11%
Chills
11%
Contusion
11%
Fall
11%
Back pain
11%
Muscle spasms
11%
Peripheral sensory neuropathy
11%
Acute kidney injury
11%
Alopecia
11%
Pneumonia
11%
Glomerular filtration rate decreased
11%
Hyponatraemia
11%
Paraesthesia
11%
Tremor
11%
Anxiety
11%
Epistaxis
8%
Leukocytosis
8%
Stomatitis
8%
Pain
8%
Pyrexia
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
8%
Lipase increased
8%
Weight decreased
8%
Hypocalcaemia
8%
Bone pain
8%
Muscular weakness
8%
Musculoskeletal chest pain
8%
Dysuria
8%
Blood alkaline phosphatase increased
8%
Atrial fibrillation
8%
Ascites
8%
Dyspepsia
8%
Pollakiuria
8%
Hypoxia
8%
Pleural effusion
8%
Hypertension
8%
Headache
8%
Hypoaesthesia
5%
Febrile neutropenia
5%
Lymphopenia
5%
Leukopenia
5%
Early satiety
5%
Influenza like illness
5%
Bacteraemia
5%
Candida infection
5%
Skin laceration
5%
Amylase increased
5%
Aspartate aminotransferase increased
5%
Gout
5%
Hyperglycaemia
5%
Hyperphosphataemia
5%
Hypoglycaemia
5%
Hypokalaemia
5%
Hypomagnesaemia
5%
Disturbance in attention
5%
Purpura
5%
Skin exfoliation
5%
Tachycardia
5%
Lacrimation increased
5%
Vision blurred
5%
Abdominal hernia
5%
Dry mouth
5%
Melaena
5%
Blast cell count increased
5%
Encephalopathy
5%
Depression
5%
Dry skin
5%
Erythema
5%
Hot flush
5%
Cardiac failure congestive
5%
Neuropathy peripheral
3%
Splenomegaly
3%
Cardiac tamponade
3%
Gastric haemorrhage
3%
Gastrointestinal haemorrhage
3%
Upper gastrointestinal haemorrhage
3%
Hepatic failure
3%
Basal cell carcinoma
3%
Chronic kidney disease
3%
Acute pulmonary oedema
3%
Hypotension
3%
Humerus fracture
3%
Laryngeal squamous cell carcinoma
3%
Neuroendocrine carcinoma of the skin
3%
Haemorrhage intracranial
3%
Atrioventricular block complete
3%
Myocardial ischaemia
3%
Pericardial effusion
3%
Abdominal pain upper
3%
Anal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fedratinib

FREEDOM Trial Design

1Treatment groups
Experimental Treatment
Group I: Administration of Fedratinib 400mg/dayExperimental Treatment1 Intervention
Self-administered Investigational Product (IP) (400 mg/day) on an outpatient basis, once daily preferably with food during an evening meal at the same time each day in consecutive 4-week (28-day) cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FEDRATINIB
2019
Completed Phase 3
~40

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,816 Total Patients Enrolled
12 Trials studying Primary Myelofibrosis
4,057 Patients Enrolled for Primary Myelofibrosis
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene CorporationIndustry Sponsor
6 Previous Clinical Trials
326 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
202 Patients Enrolled for Primary Myelofibrosis
Shelo Rose, MDStudy DirectorCelgene

Media Library

Fedratinib (JAK2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03755518 — Phase 3
Primary Myelofibrosis Research Study Groups: Administration of Fedratinib 400mg/day
Primary Myelofibrosis Clinical Trial 2023: Fedratinib Highlights & Side Effects. Trial Name: NCT03755518 — Phase 3
Fedratinib (JAK2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03755518 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are included in the research for this experiment?

"This research is not currently enrolling patients. The clinical trial was first advertised on March 27th, 2019 and was last updated on October 27th, 2022. There are, however, 137 other trials for primary myelofibrosis and 20 trials for Luspatercept that are still looking for participants."

Answered by AI

What primary objectives has this trial been designed to assess?

"The purpose of this clinical trial is to evaluate the safety and efficacy of the study medication over a period of approximately 6 months. The primary endpoint is to assess the frequency and severity of adverse events. Secondary objectives include durability of response, defined as the time from first documented response to first deterioration or death, and symptom response rate, defined as the proportion of subjects with a 50% or greater reduction in symptoms from baseline."

Answered by AI

Can you give some more examples of where Luspatercept has been studied?

"As of now, there are 20 different clinical trials being conducted for Luspatercept with 6 of them in Phase 3. Even though the majority of the Luspatercept trials are being run out of Sendai and Nagasaki, there are 1262 locations for these sorts of clinical trials."

Answered by AI

Are there any more patients being recruited for this experiment?

"Although this study is no longer recruiting patients, information on clinicaltrials.gov suggests that it was actively seeking participants at some point in the past. The original posting date was March 27th, 2019 and the most recent edit was on October 27th, 2022. There are currently 157 other trials that are actively looking for patients."

Answered by AI

Luspatercept is often associated with which condition?

"Luspatercept is a medication used to treat anemia. In some cases, it is also effective for patients with thalassemia, primary myelofibrosis, and ipss risk category intermediate-2."

Answered by AI

Is this a new or experimental type of clinical trial?

"Luspatercept has been researched since 2018, with the first study being sponsored by Celgene. 145 patients participated in the first clinical trial in 2018 which led to the drug's Phase 2 approval. As of now, 20 live trials are being conducted in 117 cities and 34 countries."

Answered by AI

When will Luspatercept be available for general use?

"Luspatercept, which is currently in Phase 3 clinical trials, has been shown to be safe and effective in prior rounds of testing."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib
2019. "A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03755518.
~6 spots leftby Apr 2025
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