LeukemiaNCT01607580
Efficacy Study of Low-dose Glucocorticoid Prophylaxis for Acute Graft-versus-host Disease(GVHD)
A study testing low-dose glucocorticoid Methylprednisolone in people with Leukemia, run by Peking University People's Hospital at 2 sites in China.
Trial summary
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, GVHD rate was still high after haploidentical HSCT. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Leukemia
- What is being tested?
- low-dose glucocorticoid Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2012to Feb 2014
- 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- no severe diarrhea no serious infection
Who cannot join
- serious diarrhea active,uncontrolled infection
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University People's Hospital，Institute of Hematology
Beijing, 100044
Peking University People's Hospital
Beijing, 100044
About this study
Official title: Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, GVHD rate was still high after haploidentical HSCT.
It was found in our previous study that CD4/CD8>=1.16、CD56bright NK>1.9×106/kg in the graft was associated with higher risk of developing acute Graft-versus-host Disease (GVHD).
The study hypothesis:
Risk stratification-directed low-dose glucocorticoid prophylaxis for acute GVHD after unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of acute GVHD
Read the detailed description
patients undergone haploidentical HSCT following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).
- Conditions
- Leukemia
- Being tested
- low-dose glucocorticoid Methylprednisolone
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose glucocorticoid MethylprednisoloneDrug
Also called Methylprednisolone
patients receive low-dose glucocorticoid from day 5 post transplant
| Study group | Role | What they receive |
|---|---|---|
| low-dose glucocorticoid | Experimental | drug Receives: Drug: low-dose glucocorticoid Methylprednisolone |
| no intervention after transplant | Other | Not described Receives: Drug: low-dose glucocorticoid Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of acute graft-versus-host disease
number of participants with acute graft-versus-host disease at 100 days
Measured: paticipants will be followed for the duration of hospital stay,an expected average of 100 days
Secondary outcomes (1)
incidence of infection
number of participants with infection (including bacterium,EB virus, cytomegalovirus and fungus ) at 100 days
Measured: participants will be followed for the duration of hospital stay,an expected average of 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2013
- Study completionFeb 2014
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 LeukemiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 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
- NCT01607580
- Sponsor's protocol ID
- PUPH IRB [2012] (26)
- Status last verified
- Sep 2020
- First submitted
- 23 May 2012
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang YJ, Xu LP, Wang Y, Zhang XH, Chen H, Chen YH, Wang FR, Han W, Sun YQ, Yan CH, Tang FF, Mo XD, Liu KY, Huang XJ. Effects of Low-Dose Glucocorticoid Prophylaxis on Chronic Graft-versus-Host Disease and Graft-versus-Host Disease-Free, Relapse-Free Survival after Haploidentical Transplantation: Long-Term Follow-Up of a Controlled, Randomized Open-Label Trial. Biol Blood Marrow Transplant. 2019 Mar;25(3):529-537. doi: 10.1016/j.bbmt.2018.11.020. Epub 2018 Nov 24.
PubMed 30481596
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT01607580
- Acronym / sponsor ID
- PUPH IRB [2012] (26)
- Conditions
- Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 May 2012 (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.
Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, GVHD rate was still high after haploidentical HSCT.
It was found in our previous study that CD4/CD8>=1.16、CD56bright NK>1.9×106/kg in the graft was associated with higher risk of developing acute Graft-versus-host Disease (GVHD).
The study hypothesis:
Risk stratification-directed low-dose glucocorticoid prophylaxis for acute GVHD after unmanipulated haploidentical blood and marrow transplantation can reduce the incidence of acute GVHD
Detailed description
patients undergone haploidentical HSCT following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-dose glucocorticoid | Experimental | Drug: low-dose glucocorticoid Methylprednisolonedrug |
| no intervention after transplant | Other | Drug: low-dose glucocorticoid Methylprednisolone |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- no severe diarrhea no serious infection
Key exclusion criteria (1 listed)
- serious diarrhea active,uncontrolled infection
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 |
|---|---|---|
| low-dose glucocorticoid MethylprednisoloneAlso: Methylprednisolonepatients receive low-dose glucocorticoid from day 5 post transplant | Drug | low-dose glucocorticoid, no intervention after transplant |
Primary outcome
incidence of acute graft-versus-host disease
Time frame: paticipants will be followed for the duration of hospital stay,an expected average of 100 days
number of participants with acute graft-versus-host disease at 100 days
1 secondary outcome
incidence of infection
Time frame: participants will be followed for the duration of hospital stay,an expected average of 100 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 24 Sep 2020.
- Derived from this study: PubMed 30481596Chang YJ, Xu LP, Wang Y, Zhang XH, Chen H, Chen YH, Wang FR, Han W, Sun YQ, Yan CH, Tang FF, Mo XD, Liu KY, Huang XJ. Effects of Low-Dose Glucocorticoid Prophylaxis on Chronic Graft-versus-Host Disease and Graft-versus-Host Disease-Free, Relapse-Free Survival after Haploidentical Transplantation: Long-Term Follow-Up of a Controlled, Randomized Open-Label Trial. Biol Blood Marrow Transplant. 2019 Mar;25(3):529-537. doi: 10.1016/j.bbmt.2018.11.020. Epub 2018 Nov 24.
- hospital websiteLink provided by the sponsor.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-dose glucocorticoid Methylprednisolone in people with Leukemia, run by Peking University People's Hospital at 2 sites 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 24 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 2 sites 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?
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?
incidence of acute graft-versus-host disease (time frame: paticipants will be followed for the duration of hospital stay,an expected average of 100 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 NCT01607580, 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 24 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.