Leukemia Clinical Trial
Official title:
Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation--a Randomized, Controlled, Clinical Trial
Verified date | September 2020 |
Source | Peking University People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 145 |
Est. completion date | February 2014 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 60 Years |
Eligibility |
Inclusion Criteria: - no severe diarrhea no serious infection Exclusion Criteria: - serious diarrhea active,uncontrolled infection |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's Hospital | Beijing | |
China | Peking University People's Hospital,Institute of Hematology | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | engrafment | numbers of participants with the engrafment of neutrophilic granulocyte and platelets at 100 days | participants will be followed for the duration of hospital stay,an expected average of 100 days | |
Primary | incidence of acute graft-versus-host disease | number of participants with acute graft-versus-host disease at 100 days | paticipants will be followed for the duration of hospital stay,an expected average of 100 days | |
Secondary | incidence of infection | number of participants with infection (including bacterium,EB virus, cytomegalovirus and fungus ) at 100 days | participants will be followed for the duration of hospital stay,an expected average of 100 days |
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