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IDH2 Inhibitor

Ruxolitinib + Enasidenib for Myelofibrosis

Phase 2
Waitlist Available
Led By Michal Bar-Natan, MD
Research Sponsored by John Mascarenhas
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 6 months
Awards & highlights

Study Summary

This trial will study the combination of the drugs ruxolitinib and enasidenib in patients with myeloproliferative neoplasms who have an IDH2 mutation.

Eligible Conditions
  • Isocitrate Dehydrogenase 2 Mutation
  • Myelofibrosis
  • Myeloproliferative Neoplasm

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of MPN participants with response
Secondary outcome measures
Proportion of MF-CP participants with any response
Proportion of MPN participants with blast response

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036
33%
Anaemia
19%
Hypertension
17%
Nasopharyngitis
16%
Weight increased
14%
Herpes zoster
14%
Constipation
14%
Abdominal pain
14%
Headache
12%
Pruritus
12%
Back pain
12%
Epistaxis
12%
Pyrexia
12%
Dizziness
10%
Asthenia
10%
Fatigue
10%
Cough
10%
Oedema peripheral
10%
Arthralgia
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Blood creatine phosphokinase increased
3%
Cystitis
3%
Bronchitis
3%
Paraesthesia
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Localised infection
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
2%
Vertigo
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with MPNExperimental Treatment2 Interventions
Ruxolitinib and Enasidenib combination therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Enasidenib
2020
Completed Phase 2
~560

Find a Location

Who is running the clinical trial?

John MascarenhasLead Sponsor
9 Previous Clinical Trials
224 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,230 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,159 Total Patients Enrolled

Media Library

Enasidenib (IDH2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04281498 — Phase 2
Isocitrate Dehydrogenase Research Study Groups: Patients with MPN
Isocitrate Dehydrogenase Clinical Trial 2023: Enasidenib Highlights & Side Effects. Trial Name: NCT04281498 — Phase 2
Enasidenib (IDH2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04281498 — Phase 2

Frequently Asked Questions

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

Are there any other existing studies that have used Ruxolitinib before?

"Currently, there are 121 ongoing clinical trials for Ruxolitinib with 14 of them in Phase 3. Interestingly, many of the clinical trials for Ruxolitinib are based in Edmonton, Alberta; however, 3739 locations around the world are conducting similar research."

Answered by AI

In how many different places is this trial taking place?

"Presently, this clinical trial is recruiting patients from 11 different locations. These include places such as Cleveland, Toronto and Ann Arbor. If you are interested in enrolling it might be beneficial to choose the closest location to reduce travel time commitments."

Answered by AI

What are some of the common conditions that ruxolitinib is used to treat?

"Ruxolitinib is primarily used to treat leukemia, myelocytic, acute. However, this medication can also be given to patients suffering from polycythemia vera or resistant/intolerant hydroxyurea."

Answered by AI

Are there any vacant positions in this clinical trial for new patients?

"The clinical trial is currently recruiting patients. According to the information on clinicaltrials.gov, the trial was first posted on 1/20/2021 and was most recently edited on 5/9/2022. They are looking for a total of 32 patients that will be recruited from 11 different locations."

Answered by AI

When was the last time Ruxolitinib was cleared by the FDA?

"The safety of Ruxolitinib was given a score of 2 because, at the time of this assessment, there is some data supporting its safety but no evidence regarding whether or not the drug is effective."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation
John Mascarenhas 2021. "Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04281498.
~1 spots leftby Apr 2025
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