Outcomes of MF Patients Exposure to Ruxolitinib During Transplantation

Sponsor

xuna (Other)

Overall Status

Recruiting

CT.gov ID

NCT04526223

Collaborator

(none)

Enrollment

Location

Arm

68.4

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Increasing experience of Ruxolitinib pre-allo SCT and data concerning Ruxolitinib during transplantation

Diagnosis MF(includ Post-ET,Post-PV,PMF,MDS/MPN with MF)
With at least two month Ruxolitinib treatment prior to transplantation
DAC+BF as myeloablative conditioning regimen
CSA from day -3 and MMF from day +1 until day 28 ATG Neovii® at dose of 7.5mg/KG for mismatch donor
received Rux at +6d in ASCT and continued to +60d

Condition or Disease	Intervention/Treatment	Phase
Time of Hematopoietic Reconstruction	Other: comprehensive treatment regimen	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Allogeneic HCT Outcomes in MF Patients Exposure to Ruxolitinib During Transplantation

Actual Study Start Date :

Apr 20, 2017

Anticipated Primary Completion Date :

Dec 20, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment group MF patients exposure to ruxolitinib during transplantation	Other: comprehensive treatment regimen Diagnosis MF(includ Post-ET,Post-PV,PMF，MDS/MPN with MF) With at least two month Ruxolitinib treatment prior to transplantation DAC+BF as myeloablative conditioning regimen received Rux at +5d in ASCT and continued to +60d

Arm

Intervention/Treatment

Experimental: treatment group

MF patients exposure to ruxolitinib during transplantation

Other: comprehensive treatment regimen

Diagnosis MF(includ Post-ET,Post-PV,PMF，MDS/MPN with MF) With at least two month Ruxolitinib treatment prior to transplantation DAC+BF as myeloablative conditioning regimen received Rux at +5d in ASCT and continued to +60d

Outcome Measures

Primary Outcome Measures

Time of neutrophils reconstruction [1 year]
Neutrophils count≧0.5G/L without G-CSF

Secondary Outcome Measures

The incidence rate of GVHD [1 year]
The incidence rate of aGVHD and cGVHD

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-60 years old, gender is not limited;
Diagnosis MF(includ Post-ET,Post-PV,PMF) according to 2016 WHO
With at least two month Ruxolitinib treatment before transplantation
Informed consent of the patient or his legal representative

Exclusion Criteria:

HCT-CI score≥2
Woman who is pregnant or nursing
MPN Patients who have received allogeneic hematopoietic stem cell transplantation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NanfangH	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

xuna

Investigators

Principal Investigator: H Nanfang, doctor, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

xuna, doctor, Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT04526223

Other Study ID Numbers:

HSCT-MF-01

First Posted:

Aug 25, 2020

Last Update Posted:

Apr 15, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Apr 15, 2022