ruxolitinib for Other Cancers

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Massachusetts General Hospital, Boston, MAOther Cancersruxolitinib - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a drug to see if it can treat BOS, a condition that may occur after HCT, a procedure where blood cells are transplanted from one person to another.

Eligible Conditions
  • Other Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 2 Years

1 Year
Change scores for PFT measurements
2 Years
Overall survival
cGVHD progression-free survival
2 years
The total systemic corticosteroid dose longitudinally over time
3 Months
absolute FEV1 increase
Treatment failure
3 and 6 Months
Improvements in chronic GVHD organ manifestations
Month 13
The incidence and types of serious adverse events

Trial Safety

Safety Progress

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

Side Effects for

INC424 (Ruxolitinib) - Study Treatment
27%Upper respiratory tract infection
17%Diarrhoea
17%Weight increased
17%Abdominal pain upper
17%Nausea
13%Alanine aminotransferase increased
13%Anaemia
10%Fatigue
10%Nasopharyngitis
10%Aspartate aminotransferase increased
10%Pleuritic pain
10%Urinary tract infection
10%Gastroenteritis
10%Pain in extremity
10%Headache
7%Nasal congestion
7%Pharyngitis
7%Abdominal pain
7%Constipation
7%Myalgia
7%Pneumonia
7%Increased appetite
7%Pyrexia
3%Pneumonia viral
3%Vomiting
3%Drug-induced liver injury
This histogram enumerates side effects from a completed 2016 Phase 2 trial (NCT02049450) in the INC424 (Ruxolitinib) - Study Treatment ARM group. Side effects include: Upper respiratory tract infection with 27%, Diarrhoea with 17%, Weight increased with 17%, Abdominal pain upper with 17%, Nausea with 17%.

Trial Design

2 Treatment Groups

newly-diagnosed BOS
1 of 2
Established BOS
1 of 2

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: ruxolitinib · No Placebo Group · Phase 2

newly-diagnosed BOS
Drug
Experimental Group · 1 Intervention: ruxolitinib · Intervention Types: Drug
Established BOS
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: 2 years

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor
323 Previous Clinical Trials
46,971 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,725 Previous Clinical Trials
31,219,247 Total Patients Enrolled
4 Trials studying Other Cancers
30,301 Patients Enrolled for Other Cancers
Zachariah DeFilipp, MDPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
93 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 17 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have at least one of two symptoms of bronchiolitis obliterans syndrome (BOS).
You stopped taking any medication for chronic graft-versus-host disease or bronchiolitis obliterans syndrome at least 4 weeks ago.

Frequently Asked Questions

What is the current enrollment for this trial?

"Affirmative. Clinicaltrials.gov hosts data that confirms this clinical trial's ongoing recruitment process, which began on April 19th 2019. Currently the research team is seeking 50 participants from one medical facility for their study and have most recently edited it on September 30th 2021." - Anonymous Online Contributor

Unverified Answer

Does the study currently cater to individuals over 30 years of age?

"The requirements for participation in this investigation stipulate that the minimum age is 18, while the maximum age to enroll is 75." - Anonymous Online Contributor

Unverified Answer

Are there any opportunities to participate in this medical experiment presently?

"The trial is open for enrollment, with its initial posting on April 19th 2019 and the most recent edit having occurred on September 30th 2021. This information can be found at clinicaltrials.gov." - Anonymous Online Contributor

Unverified Answer

Who is eligible to become a participant in this medical experiment?

"This medical trial is admitting 50 bronchiolitis patients aged between 18 and 75. To qualify, applicants must meet the following criteria: Vital Capacity (FVC or SVC); 5th percentile of predicted as lower limit of 90% confidence interval; FEV1/VC < 0.7 or at least the 5th percentile of predicted; Forced Expiratory Volume in 1 second should be less than 75% if with ≥ 10% absolute decline over 2 years; elderly patients need to adhere to NHANESIII calculations for their normal limits; Residual Volume > 120% or RV/Total Lung Capacity outwith 90%. Additionally" - Anonymous Online Contributor

Unverified Answer

Has the FDA granted approval to ruxolitinib?

"The safety of ruxolitinib is rated a 2 on the 1 to 3 scale, as there has been some evidence collected that suggests it may be safe but no proof yet demonstrating efficacy." - Anonymous Online Contributor

Unverified Answer

What is the typical application of ruxolitinib?

"Ruxolitinib has been known to be efficacious in treating polycythemia vera, polycythemia and cases where hydroxyurea is either ineffective or intolerable." - 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.