Hematopoietic Stem Cell TransplantationPhase 4NCT02412423
Post-transplantation Cyclophosphamide for Haploidentical Transplant From Maternal or Collateral Donors
A Phase 4 study testing post-transplantation cyclophosphamide in people with Hematopoietic Stem Cell Transplantation, run by Peking University People's Hospital at 1 site in China.
Trial summary
In "beijing model" for haploidentical transplant, the rate of acute graft-versus-host disease (GVHD) from maternal or collateral donors was significantly higher than that from other kins. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- post-transplantation cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Mar 2017
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- haploidentical patients from maternal or collateral donors
Who cannot join
- uncontrolled infection before transplant
Trial locations and contacts
1 site in 1 country.
About this study
In "beijing model" for haploidentical transplant, the rate of acute graft-versus-host disease (GVHD) from maternal or collateral donors was significantly higher than that from other kins. To reduce the GVHD incidence from maternal or collateral donors, post-transplantation cyclophosphamide is planned to be added into the protocol in "beijing model".
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- post-transplantation cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-transplantation cyclophosphamideDrug
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | post-transplantation cyclophosphamide Receives: Drug: post-transplantation cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of acute GVHD
Measured: participants will be followed for an expected average of 365 days
Secondary outcomes (3)
rate of non-relapse mortality
Measured: participants will be followed for an expected average of 365 days
rate of relapse
Measured: participants will be followed for an expected average of 365 days
probability of survival
Measured: participants will be followed for an expected average of 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Huang,MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412423
- Sponsor's protocol ID
- 2015PHB016-01
- Status last verified
- Sep 2020
- First submitted
- 5 Apr 2015
- Last updated
- 17 Sep 2020
- Results posted
- No
Publications
Wang Y, Wu DP, Liu QF, Xu LP, Liu KY, Zhang XH, Yu WJ, Xu Y, Huang F, Huang XJ. Low-dose post-transplant cyclophosphamide and anti-thymocyte globulin as an effective strategy for GVHD prevention in haploidentical patients. J Hematol Oncol. 2019 Sep 3;12(1):88. doi: 10.1186/s13045-019-0781-y.
PubMed 31481121
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-transplantation Cyclophosphamide for Haploidentical Transplant From Maternal or Collateral Donors
- ClinicalTrials.gov ID
- NCT02412423
- Acronym / sponsor ID
- 2015PHB016-01
- Conditions
- Hematopoietic Stem Cell Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 9 Apr 2015 (estimated)
- 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.
In "beijing model" for haploidentical transplant, the rate of acute graft-versus-host disease (GVHD) from maternal or collateral donors was significantly higher than that from other kins. To reduce the GVHD incidence from maternal or collateral donors, post-transplantation cyclophosphamide is planned to be added into the protocol in "beijing model".
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: post-transplantation cyclophosphamidepost-transplantation cyclophosphamide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- haploidentical patients from maternal or collateral donors
Key exclusion criteria (1 listed)
- uncontrolled infection before transplant
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 |
|---|---|---|
| post-transplantation cyclophosphamide | Drug | treatment group |
Primary outcome
rate of acute GVHD
Time frame: participants will be followed for an expected average of 365 days
3 secondary outcomes
rate of non-relapse mortality
Time frame: participants will be followed for an expected average of 365 days
rate of relapse
Time frame: participants will be followed for an expected average of 365 days
probability of survival
Time frame: participants will be followed for an expected average of 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Derived from this study: PubMed 31481121Wang Y, Wu DP, Liu QF, Xu LP, Liu KY, Zhang XH, Yu WJ, Xu Y, Huang F, Huang XJ. Low-dose post-transplant cyclophosphamide and anti-thymocyte globulin as an effective strategy for GVHD prevention in haploidentical patients. J Hematol Oncol. 2019 Sep 3;12(1):88. doi: 10.1186/s13045-019-0781-y.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing post-transplantation cyclophosphamide in people with Hematopoietic Stem Cell Transplantation, run by Peking University People's Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Sep 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of acute GVHD (time frame: participants will be followed for an expected average of 365 days). 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 NCT02412423, which also lists 1 linked publication.
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 17 Sep 2020.