Advanced MDS Without Identical Sibling Donor Clinical Trial
Official title:
Haplo-identical/Mismatched Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome
| Verified date | April 2015 |
| Source | Peking University People's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Ministry of Health |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 116 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Contraindication to HSCT - Pregnancy - Mental illness |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| China | Aerospace center hospital | Beijing | |
| China | Peking University People's Hospital | Beijing | |
| China | Chongqing Medical University The 1st Affiliated Hospital | Chongqing | Sichuan |
| China | The 3rd Army Medical University The 2nd Affiliated Hospital | Chongqing | Sichuan |
| China | Nanfang Hospital, Nanfang Medical University | Guangzhou | Guangdong |
| China | Nanjing Gulou Hospital | Nanjing | Jiangsu |
| China | Suzhou University The 1st Affiliated Hospital | Suzhou | Jiangsu |
| China | Hebei Tangshan Steel and Iron Company Hospital | Tangshan | Hebei |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University People's Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | survival rate | number of participants with survival at one year | participants will be followed for an expected average of one year | No |
| Secondary | incidence of non-relapse mortality | number of participants with non-relapse mortality at one year | one year | Yes |