Clinical trial NCT04526223: Outcomes of MF Patients Exposure to Ruxolitinib During Transplantation
Official title: Allogeneic HCT Outcomes in MF Patients Exposure to Ruxolitinib During Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Time of Hematopoietic Reconstruction
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Time of neutrophils reconstruction
timeFrame: 1 year
Secondary outcomes:
measure: The incidence rate of GVHD
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanfangH
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: H Nanfang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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, 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.
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.