NCT04526223

Brief Summary

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

  1. 1.Diagnosis MF(includ Post-ET,Post-PV,PMF,MDS/MPN with MF)
  2. 2.With at least two month Ruxolitinib treatment prior to transplantation
  3. 3.DAC+BF as myeloablative conditioning regimen
  4. 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. 5.received Rux at +6d in ASCT and continued to +60d

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

5.7 years

First QC Date

February 16, 2020

Last Update Submit

April 9, 2022

Conditions

Time of Hematopoietic Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Time of neutrophils reconstruction

    Neutrophils count≧0.5G/L without G-CSF

    1 year

Secondary Outcomes (1)

  • The incidence rate of GVHD

    1 year

Study Arms (1)

treatment group

EXPERIMENTAL

MF patients exposure to ruxolitinib during transplantation

Other: comprehensive treatment regimen

Interventions

comprehensive treatment regimenOTHER

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

treatment group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NanfangH

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (4)

  • Barbui T, Tefferi A, Vannucchi AM, Passamonti F, Silver RT, Hoffman R, Verstovsek S, Mesa R, Kiladjian JJ, Hehlmann R, Reiter A, Cervantes F, Harrison C, Mc Mullin MF, Hasselbalch HC, Koschmieder S, Marchetti M, Bacigalupo A, Finazzi G, Kroeger N, Griesshammer M, Birgegard G, Barosi G. Philadelphia chromosome-negative classical myeloproliferative neoplasms: revised management recommendations from European LeukemiaNet. Leukemia. 2018 May;32(5):1057-1069. doi: 10.1038/s41375-018-0077-1. Epub 2018 Feb 27.

    PMID: 29515238BACKGROUND

  • Kroger N, Shahnaz Syed Abd Kadir S, Zabelina T, Badbaran A, Christopeit M, Ayuk F, Wolschke C. Peritransplantation Ruxolitinib Prevents Acute Graft-versus-Host Disease in Patients with Myelofibrosis Undergoing Allogenic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2018 Oct;24(10):2152-2156. doi: 10.1016/j.bbmt.2018.05.023. Epub 2018 May 22.

    PMID: 29800615BACKGROUND

  • Shahnaz Syed Abd Kadir S, Christopeit M, Wulf G, Wagner E, Bornhauser M, Schroeder T, Crysandt M, Mayer K, Jonas J, Stelljes M, Badbaran A, Ayuketang Ayuk F, Triviai I, Wolf D, Wolschke C, Kroger N. Impact of ruxolitinib pretreatment on outcomes after allogeneic stem cell transplantation in patients with myelofibrosis. Eur J Haematol. 2018 Sep;101(3):305-317. doi: 10.1111/ejh.13099. Epub 2018 Jul 4.

    PMID: 29791053BACKGROUND

  • Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.

    PMID: 29316837BACKGROUND

Study Officials

  • H Nanfang, doctor

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

na J xu

CONTACT

8618620698390sprenaa@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

February 16, 2020

First Posted

August 25, 2020

Study Start

April 20, 2017

Primary Completion

December 20, 2022

Study Completion

December 31, 2022

Last Updated

April 15, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Locations

CN(1)