Outcomes of MF Patients Exposure to Ruxolitinib During Transplantation

April 9, 2022 updated by: xuna

Allogeneic HCT Outcomes in MF Patients Exposure to Ruxolitinib During Transplantation

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • NanfangH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of neutrophils reconstruction
Time Frame: 1 year
Neutrophils count≧0.5G/L without G-CSF
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of GVHD
Time Frame: 1 year
The incidence rate of aGVHD and cGVHD
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

xuna

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2017

Primary Completion (Anticipated)

December 20, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 16, 2020

First Submitted That Met QC Criteria

August 21, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • HSCT-MF-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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