Advanced MDS Without Identical Sibling DonorNCT01793675
Haplo-identical/Mismatched Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome
An observational study of Advanced MDS Without Identical Sibling Donor, run by Peking University People's Hospital at 8 sites in China.
Trial summary
Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the only curative treatment for myelodysplastic syndrome (MDS), especially for advanced MDS (blast >5%). However, many patients cannot find an HLA-matched donor. haploidentical donor is an alternative stem cell source. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Advanced MDS Without Identical Sibling Donor
- What is being tested?
- transplant with haploidentical donor
- Type of treatment
- Surgery or procedure
- How many people
- 116 participants
- Where
- 8 sitesChina
- Study dates
- Apr 2003to Dec 2014
- Phase
- Observational
- 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 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients with MDS:1)intermediate-2 or high risk 2)low or intermediate-1 risk, drug resistance or disease progression
Who may be able to join
- Patients with MDS (1)intermediate-2 or high risk (2)low or intermediate-1 risk with drug resistance or disease progression
- without identical sibling donor
Who cannot join
- Contraindication to HSCT
- Pregnancy
- Mental illness
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Peking University People's Hospital
Beijing, 100044
Aerospace center hospital
Beijing, 100781
Chongqing Medical University The 1st Affiliated Hospital
Chongqing, Sichuan
The 3rd Army Medical University The 2nd Affiliated Hospital
Chongqing, Sichuan
Nanfang Hospital, Nanfang Medical University
Guangzhou, Guangdong, 510515
Nanjing Gulou Hospital
Nanjing, Jiangsu
Suzhou University The 1st Affiliated Hospital
Suzhou, Jiangsu
Hebei Tangshan Steel and Iron Company Hospital
Tangshan, Hebei
About this study
Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the only curative treatment for myelodysplastic syndrome (MDS), especially for advanced MDS (blast >5%). However, many patients cannot find an HLA-matched donor. haploidentical donor is an alternative stem cell source.
the study hypothesis: Haploidentical/mismatched hematopoietic stem cell transplantation can improve the survival of patients with myelodysplastic syndrome
- Being tested
- transplant with haploidentical donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transplant with haploidentical donorProcedure or surgery
Also called haploidentical transplant
patients with advanced MDS without identical sibling donor receive haploidentical transplant
| Study group | Role | What they receive |
|---|---|---|
| haploidentical transplant | transplant with haploidentical donor Receives: Procedure: transplant with haploidentical donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
number of participants with survival at one year
Measured: participants will be followed for an expected average of one year
Secondary outcomes (1)
incidence of non-relapse mortality
number of participants with non-relapse mortality at one year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startApr 2003
- Primary completionDec 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MDS Without Identical Sibling DonorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Huang, Peking University People's Hospital
- Investigators
- xiaojun huang, M.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793675
- Sponsor's protocol ID
- PUPH IRB [2013] (04)
- Status last verified
- Apr 2015
- First submitted
- 14 Feb 2013
- Last updated
- 29 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haplo-identical/Mismatched Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT01793675
- Acronym / sponsor ID
- PUPH IRB [2013] (04)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Feb 2013 (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.
Allogeneic hematopoietic stem cell transplantation (HSCT) is currently the only curative treatment for myelodysplastic syndrome (MDS), especially for advanced MDS (blast >5%). However, many patients cannot find an HLA-matched donor. haploidentical donor is an alternative stem cell source.
the study hypothesis: Haploidentical/mismatched hematopoietic stem cell transplantation can improve the survival of patients with myelodysplastic syndrome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| haploidentical transplant | – | Procedure: transplant with haploidentical donortransplant with haploidentical donor |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients with MDS:1)intermediate-2 or high risk 2)low or intermediate-1 risk, drug resistance or disease progression
Key inclusion criteria (2 listed)
- Patients with MDS (1)intermediate-2 or high risk (2)low or intermediate-1 risk with drug resistance or disease progression
- without identical sibling donor
Key exclusion criteria (3 listed)
- Contraindication to HSCT
- Pregnancy
- Mental illness
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 |
|---|---|---|
| transplant with haploidentical donorAlso: haploidentical transplantpatients with advanced MDS without identical sibling donor receive haploidentical transplant | Procedure or surgery | haploidentical transplant |
Primary outcome
survival rate
Time frame: participants will be followed for an expected average of one year
number of participants with survival at one year
1 secondary outcome
incidence of non-relapse mortality
Time frame: one year
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 29 Apr 2015.
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.
xiaojun huang, M.D. principal investigator
Peking University People's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced MDS Without Identical Sibling Donor, run by Peking University People's Hospital at 8 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 2 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: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
survival rate (time frame: participants will be followed for an expected average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2015.