Outcomes of MF Patients Exposure to Ruxolitinib During Transplantation

Time of Hematopoietic Reconstruction Clinical Trial

Official title:

Allogeneic HCT Outcomes in MF Patients Exposure to Ruxolitinib During Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04526223
• Other study ID #: HSCT-MF-01
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: na J xu
• Phone: 8618620698390
• Email: sprenaa[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Time of Hematopoietic Reconstruction

Intervention

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

Locations

Country	Name	City	State
China	NanfangH	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
xuna

Country where clinical trial is conducted

China, 

References & 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. Review. — View Citation

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. — View Citation

Kröger 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. — View Citation

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, Kröger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of neutrophils reconstruction	Neutrophils count?0.5G/L without G-CSF	1 year
Secondary	The incidence rate of GVHD	The incidence rate of aGVHD and cGVHD	1 year