Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414681
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-23
Brief Title:
Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate Contraindicated or Declined
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
An Open Label Pilot Trial of the Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate Contraindicated or Declined
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this open-label single-center pilot trial is to test the combination of Tagraxofusp TAG with Pacritinib PAC in patients with intermediate-II or higher myelofibrosis MF who have had prior therapy with the approved JAK12 inhibitor or in which therapy with the approved JAK12 inhibitors is not appropriate contraindicated or declined by the subjects
The Primary Objective is to
1 Characterized efficacy of the combination of Tagraxofusp and Pacritinib
The Secondary Objective is to
1 characterize the safety profile of the combination Tagraxofusp and Pacritinib
2 Characterize the feasibility of the combination Tagraxofusp and Pacritinib 3 Characterize hematologic improvement with the combination Tagraxofusp and Pacritinib
4 Evaluate and compare the effect of Tagraxofusp and Pacritinib on participant reports of MF symptoms
Exploratory
Pharmacokinetic PK testing of Tagraxofusp and Pacritinib to assess clinical predictors of response
Next Generation Sequencing NGS Testing to define the number and the allele burden of pathological mutations as well as the changes over the course of therapy both in regard to progression and response
Blood will be collected and stored at KU BRCF for future study related PK analysis
The Primary Objective is to
1 Characterized efficacy of the combination of Tagraxofusp and Pacritinib
The Secondary Objective is to
1 characterize the safety profile of the combination Tagraxofusp and Pacritinib
2 Characterize the feasibility of the combination Tagraxofusp and Pacritinib 3 Characterize hematologic improvement with the combination Tagraxofusp and Pacritinib
4 Evaluate and compare the effect of Tagraxofusp and Pacritinib on participant reports of MF symptoms
Exploratory
Pharmacokinetic PK testing of Tagraxofusp and Pacritinib to assess clinical predictors of response
Next Generation Sequencing NGS Testing to define the number and the allele burden of pathological mutations as well as the changes over the course of therapy both in regard to progression and response
Blood will be collected and stored at KU BRCF for future study related PK analysis
Detailed Description:
A combination of these agent provides rational scientific merit and compatible mechanisms of action by targeting myelofibrosis stem cells and BM environment in combination with effective JAK2 and IRAK1 inhibition resulting in improvement in MPN related symptoms and splenomegaly without overlapping toxicities Both agents have been studied in mildly depleted bone marrow phenotypes showing safety and hematological improvements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None