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Status unknownNCT04526223Updated Apr 15, 2022

Outcomes of MF Patients Exposure to Ruxolitinib During Transplantation

An interventional study of comprehensive treatment regimen in Time of Hematopoietic Reconstruction, sponsored by xuna. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-04-15.

Sponsored by xuna · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Apr 2017, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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
02

Conditions studied

  • Time of Hematopoietic Reconstruction
03

In context

Lead sponsor

xuna is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    treatment group

    MF patients exposure to ruxolitinib during transplantation

    Other: comprehensive treatment regimen

Interventions

  • Othercomprehensive 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

06

What researchers measure

Primary outcomes

  1. Time of neutrophils reconstruction

    Neutrophils count≧0.5G/L without G-CSF

    Time frame: 1 year

Secondary outcomes

  1. The incidence rate of GVHD

    The incidence rate of aGVHD and cGVHD

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • NanfangH
    Guangzhou, Guangdong 510515, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29515238 ↗
  • 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. PubMed 29800615 ↗
  • 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. PubMed 29791053 ↗
  • 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. PubMed 29316837 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04526223
Lead sponsor
xuna
Responsible party
xuna (doctor, Nanfang Hospital, Southern Medical University) — Sponsor-investigator
First posted
Aug 25, 2020
Start date
Apr 20, 2017
Primary completion
Dec 20, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Apr 15, 2022

Study contacts

na J xu
Contact
sprenaa@163.com
8618620698390 ext. 0
H Nanfang, doctor
principal investigator · Nanfang Hospital, Southern Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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