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DNA Methyltransferase Inhibitor
Fedratinib + Decitabine for Blast Crisis
Phase 1
Recruiting
Led By Joseph Jurcic, MD
Research Sponsored by Joseph Jurcic
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 up to 3 years
Awards & highlights
Study Summary
This trial is testing the safety and tolerability of two drugs, fedratinib and decitabine, in combination. The goal is to find the maximum tolerated dose (MTD).
Who is the study for?
This trial is for adults with advanced-phase Myeloproliferative Neoplasms (MPN-AP/BP) who have a specific percentage of blasts in their blood or bone marrow and adequate organ function. It's not for those who've had certain treatments recently, are pregnant, have severe medical conditions like heart failure or liver cirrhosis, or an immediate candidate for stem cell transplant.Check my eligibility
What is being tested?
The study aims to find the safest dose combination of two drugs: Fedratinib and Decitabine. Participants will receive these medications to see how well they tolerate them and what effects they have on MPNs that are in an accelerated phase (AP) or blast phase (BP).See study design
What are the potential side effects?
Potential side effects may include gastrointestinal symptoms like nausea and vomiting, changes in blood counts leading to increased risk of infections or bleeding, liver enzyme alterations suggesting liver stress, fatigue, and possible neurological issues such as confusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of Decitabine and Fedratinib
Secondary outcome measures
Complete Remission (CR) Rate
Composite Complete Remission (CRc) Rate
Overall Survival (OS)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Fedratinib 400 mgExperimental Treatment2 Interventions
Cohort 2: 400 mg of Fedratinib by mouth, once daily during each 28-day cycle
Group II: Fedratinib 300 mgExperimental Treatment2 Interventions
Cohort 1: 300 mg of Fedratinib by mouth, once daily during each 28-day cycle
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Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,019 Total Patients Enrolled
Joseph JurcicLead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
Joseph Jurcic, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
82 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving treatment for acute myeloid leukemia.I have a matching donor for a stem cell transplant.I have been diagnosed with acute myelofibrosis.I have a blood disorder with specific characteristics and a history of ET, PV, or PMF.I have never had Wernicke's encephalopathy.I haven't had chemotherapy or new drugs, except hydroxyurea, in the last 4 weeks.I do not have any severe illnesses or conditions that my doctor says could interfere with the study.
Research Study Groups:
This trial has the following groups:- Group 1: Fedratinib 300 mg
- Group 2: Fedratinib 400 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment accepting new participants?
"Affirmative. Information posted on clinicaltrials.gov demonstrates that this medical investigation is currently receiving applications from participants, having initially been advertised on September 1st 2022. A total of 13 individuals are needed to be recruited across a single location for the trial's completion."
Answered by AI
How many individuals have been approved to partake in this clinical experiment?
"Affirmative. According to the information accessible on clinicaltrials.gov, this research is presently engaging participants. It was initially published on September 1st 2022 and updated as recently as August 30th 2022. This scientific endeavour requires 13 patients from a single site for participation."
Answered by AI
Could you please elucidate the potential risks of Decitabine 20 mg/m2 for patients?
"As this is a Phase 1 medical trial, the safety of Decitabine 20 mg/m2 was rated at a conservative 1 due to limited data concerning its efficacy and potential side effects."
Answered by AI
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