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Ruxolitinib Not Eligible pre-HSCT for Myelofibrosis

Memorial Sloan Kettering Cancer Center, New York, NY
MyelofibrosisRuxolitinib - Drug
Eligibility
18 - 75
All Sexes

Study Summary

This trial is testing Ruxolitinib as a possible treatment for Myelofibrosis, a disorder where the bone marrow doesn't make enough blood cells.

Eligible Conditions
  • Myelofibrosis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Ruxolitinib
1
Imetelstat
1
CK0804

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 1 and 2 years

1 and 2 years
Cumulative incidence of cGVHD
Overall Survival
Progression Free Survival
1 year
GVHD free and relapse free survival at 1 year
2 years
Hemopoietic stem cell transplant
Rate of Engraftment
Toxicity rate
6 months
Cumulative incidence of aGVHD

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Ruxolitinib
1
Imetelstat
1
CK0804

Side Effects for

Best Available Therapy
23%Pruritus
12%Headache
9%Diarrhoea
9%Upper respiratory tract infection
8%Thrombocytopenia
8%Asthenia
8%Fatigue
7%Dizziness
7%Nausea
7%Night sweats
7%Haematocrit increased
5%Leukocytosis
5%Constipation
5%Influenza
5%Decreased appetite
5%Erythema
5%Weight decreased
4%Arthralgia
4%Hypertension
4%Abdominal pain upper
4%Thrombocytosis
3%Tinnitus
3%Abdominal discomfort
3%Dyspepsia
3%Oedema peripheral
3%Nasopharyngitis
3%Myalgia
3%Pain in extremity
3%Cough
3%Dyspnoea
3%Epistaxis
3%Bronchitis
1%Anaemia
1%Atrial fibrillation
1%Gastrointestinal haemorrhage
1%Rectal haemorrhage
1%Cellulitis
1%Hyponatraemia
1%Bladder transitional cell carcinoma
1%Syncope
1%Extremity necrosis
1%Abdominal pain
1%Pyrexia
1%Flatulence
1%Blood lactate dehydrogenase increased
1%Gamma-glutamyltransferase increased
1%Musculoskeletal pain
1%Hyperuricaemia
1%Osteoarthritis
1%Haematoma
1%Pneumonia
1%Septic shock
1%Neutropenia
1%Meningitis
1%Vertigo
1%Depression
1%Myelofibrosis
1%Respiratory failure
1%Abdominal distension
1%Vomiting
1%Weight increased
1%Muscle spasms
1%Acute myeloid leukaemia
1%Breast cancer
1%Cardiac failure
1%Renal failure
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02038036) in the Best Available Therapy ARM group. Side effects include: Pruritus with 23%, Headache with 12%, Diarrhoea with 9%, Upper respiratory tract infection with 9%, Thrombocytopenia with 8%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Ruxolitinib Not Eligible pre-HSCT
1 of 2
Ruxolitinib Eligible pre-HSCT
1 of 2

Experimental Treatment

54 Total Participants · 2 Treatment Groups

Primary Treatment: Ruxolitinib Not Eligible pre-HSCT · No Placebo Group · Phase 2

Ruxolitinib Not Eligible pre-HSCT
Drug
Experimental Group · 1 Intervention: Ruxolitinib · Intervention Types: Drug
Ruxolitinib Eligible pre-HSCT
Drug
Experimental Group · 1 Intervention: Ruxolitinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 and 2 years

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor
330 Previous Clinical Trials
47,876 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,782 Previous Clinical Trials
31,225,250 Total Patients Enrolled
Gabriela Hobbs, MD4.04 ReviewsPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
4 Previous Clinical Trials
116 Total Patients Enrolled
5Patient Review
I was always made to feel cared for, never rushed, and given as much time as I needed during appointments. Dr. Smith is also very knowledgeable and quick to return calls. I am very impressed with her as both a physician and a human being.

Eligibility Criteria

Age 18 - 75 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
For Cohort 2 only: You cannot have an enlarged spleen or symptoms of myelofibrosis, or you have previously taken ruxolitinib and it did not work for you. Additionally, you cannot be allergic to ruxolitinib.
References

Frequently Asked Questions

How many people are total are enrolled in this clinical trial?

"Yes, this is an ongoing clinical trial that was originally posted on 8/28/2018. The latest update to the study's information was made on 10/21/2022. At present, 54 patients are being recruited from 5 different medical facilities." - Anonymous Online Contributor

Unverified Answer

Are patients currently being accepted for this clinical trial?

"The trial is currently ongoing, as seen on clinicaltrials.gov. Recruitment for the study began on 8/28/2018 and the most recent update was on 10/21/2022." - Anonymous Online Contributor

Unverified Answer

Does this study have any age requirements?

"For this particular clinical trial, patients between 18-75 years old are eligible to enroll. By comparison, there are 34 trials for patients younger than 18 and 195 trials for patients older than 65." - Anonymous Online Contributor

Unverified Answer

What type of patient would not be able to receive Ruxolitinib prior to a HSCT procedure?

"Ruxolitinib Not Eligible pre-HSCT is effective in treating polycythemia vera. This drug can also help patients with conditions like hydroxyurea resistance or intolerance, and primary myelofibrosis." - Anonymous Online Contributor

Unverified Answer

To whom is this clinical trial available?

"The ideal candidate for this clinical trial would be somebody suffering from primary myelofibrosis between the ages of 18 and 75. So far, 54 people have met the qualifications and enrolled in the study." - Anonymous Online Contributor

Unverified Answer

Would you be able to share how many hospitals are a part of this research?

"There are 4 primary centres for this trial. They are Vanderbilt University, Washington University, The Ohio State University Wexner Medical Center, and 5 other locations." - Anonymous Online Contributor

Unverified Answer

How does Ruxolitinib Not Eligible pre-HSCT affect patients?

"While there is some evidence supporting the safety of Ruxolitinib, it did not yet receive a score of 3 because Phase 2 trials have limited data on efficacy." - Anonymous Online Contributor

Unverified Answer

Are there other cases where Ruxolitinib wasn't effective in treating patients before a stem cell transplant?

"Ruxolitinib was first studied in 2002 at the National Institutes of Health Clinical Center. As of now, there are 92 completed trials and 99 live clinical trials studying this medication. A large portion of these studies are based in Nashville, Tennessee." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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