Time of Hematopoietic ReconstructionNCT04526223
Outcomes of MF Patients Exposure to Ruxolitinib During Transplantation
A study testing comprehensive treatment regimen in people with Time of Hematopoietic Reconstruction, run by xuna at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Time of Hematopoietic Reconstruction
- What is being tested?
- comprehensive treatment regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2017to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- HCT-CI score≥2
- Woman who is pregnant or nursing
- MPN Patients who have received allogeneic hematopoietic stem cell transplantation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
NanfangH
Guangzhou, Guangdong, 510515
xu na, doctor, 18620698390, sprenaa@163.com
About this study
Official title: Allogeneic HCT Outcomes in MF Patients Exposure to Ruxolitinib During Transplantation
Increasing experience of Ruxolitinib pre-allo SCT and data concerning Ruxolitinib during transplantation
- 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
- CSA from day -3 and MMF from day +1 until day 28 ATG Neovii® at dose of 7.5mg/KG for mismatch donor
- received Rux at +6d in ASCT and continued to +60d
- Conditions
- Time of Hematopoietic Reconstruction
- Being tested
- comprehensive treatment regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive treatment regimenOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | MF patients exposure to ruxolitinib during transplantation Receives: Other: comprehensive treatment regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of neutrophils reconstruction
Neutrophils count≧0.5G/L without G-CSF
Measured: 1 year
Secondary outcomes (1)
The incidence rate of GVHD
The incidence rate of aGVHD and cGVHD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start20 Apr 2017
- Primary completion20 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Time of Hematopoietic ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xuna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xuna, Nanfang Hospital, Southern Medical University
- Investigators
- H Nanfang, doctor, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526223
- Sponsor's protocol ID
- HSCT-MF-01
- Status last verified
- Apr 2022
- First submitted
- 16 Feb 2020
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 29515238Kroger 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 29800615Shahnaz 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 29791053Jagasia 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic HCT Outcomes in MF Patients Exposure to Ruxolitinib During Transplantation
- ClinicalTrials.gov ID
- NCT04526223
- Acronym / sponsor ID
- HSCT-MF-01
- Conditions
- Time of Hematopoietic Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- xunaUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Increasing experience of Ruxolitinib pre-allo SCT and data concerning Ruxolitinib during transplantation
- 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
- CSA from day -3 and MMF from day +1 until day 28 ATG Neovii® at dose of 7.5mg/KG for mismatch donor
- received Rux at +6d in ASCT and continued to +60d
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Other: comprehensive treatment regimenMF patients exposure to ruxolitinib during transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- HCT-CI score≥2
- Woman who is pregnant or nursing
- MPN Patients who have received allogeneic hematopoietic stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive treatment regimen1. 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 | Other | treatment group |
Primary outcome
Time of neutrophils reconstruction
Time frame: 1 year
Neutrophils count≧0.5G/L without G-CSF
1 secondary outcome
The incidence rate of GVHD
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 29515238Barbui 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.
- Background: PubMed 29800615Kroger 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.
- Background: PubMed 29791053Shahnaz 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.
- Background: PubMed 29316837Jagasia 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H Nanfang, doctor principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive treatment regimen in people with Time of Hematopoietic Reconstruction, run by xuna at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact na J xu (8618620698390 ext. 0, sprenaa@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of neutrophils reconstruction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04526223, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.