RecruitingPhase 2NCT04370301

Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis

Pilot Study of JAK Inhibitor Therapy Followed by Reduced Intensity Haploidentical Transplantation for Patients With Myelofibrosis


Sponsor

Fred Hutchinson Cancer Center

Enrollment

20 participants

Start Date

Feb 9, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This initial cohort of this phase II trial studied the outcomes of using a JAK inhibitor prior to reduced intensity haploidentical (Haplo) transplantation for the treatment of primary or secondary myelofibrosis (MF). The primary risk of using Haplo HCT in patients with MF is graft failure. In the first cohort, all patients engrafted. There were no instances of graft failure. However, a large number of patients did have graft versus host disease as a complication of their transplant. JAK inhibitors have since been approved for the indication of graft versus host disease treatment. And we are also using them for graft versus host disease prevention in a study of MF patients with sibling and unrelated donors. Therefore, we are opening a new cohort of the current study using the JAK inhibitor prior to, during and after Haplo transplant. Our goal is to decrease graft versus host disease in patients receiving a Haplo MF transplant without increasing the risk of graft failure.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a procedure called Bone Marrow Aspiration, and others for people with primary myelofibrosis and secondary myelofibrosis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Given IV

DRUGJAK Inhibitor

Given PO

DRUGFludarabine

Given IV

BIOLOGICALRecombinant Granulocyte Colony-Stimulating Factor

Given SC

DRUGMelphalan

Given IV

DRUGMycophenolate Mofetil

Given PO

PROCEDUREPeripheral Blood Stem Cell Transplantation

Given IV

DRUGTacrolimus

Given IV and PO

RADIATIONTotal-Body Irradiation

Undergo TBI

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDUREBone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDUREMultigated Acquisition Scan

Undergo MUGA


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT04370301


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