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Efficacy Study of Low-dose Glucocorticoid Prophylaxis for Acute Graft-versus-host Disease(GVHD)

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ClinicalTrials.gov Identifier: NCT01607580
Recruitment Status : Unknown
Verified January 2014 by Xiaojun Huang, Peking University People's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 30, 2012
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang, Peking University People's Hospital

Brief 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.

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


Condition or disease Intervention/treatment Phase
Leukemia Drug: low-dose glucocorticoid Methylprednisolone Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Risk Stratification-directed Low-dose Glucocorticoid Prophylaxis for Acute GVHD After Unmanipulated Haploidentical Blood and Marrow Transplantation——a Randomized, Controlled, Clinical Trial
Study Start Date : June 2012
Actual Primary Completion Date : November 2013
Estimated Study Completion Date : February 2014


Arm Intervention/treatment
Experimental: low-dose glucocorticoid
drug
Drug: low-dose glucocorticoid Methylprednisolone
patients receive low-dose glucocorticoid from day 5 post transplant
Other Name: Methylprednisolone
no intervention after transplant Drug: low-dose glucocorticoid Methylprednisolone
patients receive low-dose glucocorticoid from day 5 post transplant
Other Name: Methylprednisolone



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. incidence of infection [ Time Frame: participants will be followed for the duration of hospital stay,an expected average of 100 days ]
    number of participants with infection (including bacterium,EB virus, cytomegalovirus and fungus ) at 100 days


Other Outcome Measures:
  1. engrafment [ Time Frame: participants will be followed for the duration of hospital stay,an expected average of 100 days ]
    numbers of participants with the engrafment of neutrophilic granulocyte and platelets at 100 days



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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • no severe diarrhea no serious infection

Exclusion Criteria:

  • serious diarrhea active,uncontrolled infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607580


Locations
China
Peking University People's Hospital
Beijing, China, 100044
Peking University People's Hospital,Institute of Hematology
Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital

Additional Information:
Responsible Party: Xiaojun Huang, director of Peking University People's Hospital,Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01607580     History of Changes
Other Study ID Numbers: PUPH IRB [2012] (26)
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents