Outcomes of MF Patients Exposure to Ruxolitinib During Transplantation
NCT ID: NCT04526223
Last Updated: 2022-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2017-04-20
2022-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment group
MF patients exposure to ruxolitinib during transplantation
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
2. Woman who is pregnant or nursing
3. MPN Patients who have received allogeneic hematopoietic stem cell transplantation
18 Years
60 Years
ALL
No
Sponsors
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xuna
OTHER
Responsible Party
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xuna
doctor
Principal Investigators
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H Nanfang, doctor
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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NanfangH
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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HSCT-MF-01
Identifier Type: -
Identifier Source: org_study_id
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