Decitabine 20 mg/m2 for Myeloproliferative Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Myeloproliferative NeoplasmsDecitabine 20 mg/m2 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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).

Eligible Conditions
  • Myeloproliferative Neoplasms

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 3 years

Up to 3 years
Complete Remission (CR) Rate
Composite Complete Remission (CRc) Rate
Overall Survival (OS)
Partial Remission (PR) Rate
Progression Free Survival (PFS)
Week 8
Maximum Tolerated Dose (MTD) of Decitabine and Fedratinib

Trial Safety

Trial Design

2 Treatment Groups

Fedratinib 400 mg
1 of 2
Fedratinib 300 mg
1 of 2

Experimental Treatment

13 Total Participants · 2 Treatment Groups

Primary Treatment: Decitabine 20 mg/m2 · No Placebo Group · Phase 1

Fedratinib 400 mgExperimental Group · 2 Interventions: Decitabine 20 mg/m2, Fedratinib Oral Capsule 400 mg · Intervention Types: Drug, Drug
Fedratinib 300 mgExperimental Group · 2 Interventions: Decitabine 20 mg/m2, Fedratinib Oral Capsule 300 mg · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Joseph JurcicLead Sponsor
1 Previous Clinical Trials
Bristol-Myers SquibbIndustry Sponsor
2,496 Previous Clinical Trials
3,930,314 Total Patients Enrolled
Joseph Jurcic, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
76 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an estimated creatinine clearance of ≥ 50 mL/min.
You are at least 18 years of age.