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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01607580
First received: May 23, 2012
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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 Intervention
Leukemia
Drug: low-dose glucocorticoid Methylprednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    number of participants with acute graft-versus-host disease at 100 days


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


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


Enrollment: 145
Study Start Date: June 2012
Estimated Study Completion Date: February 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

patients undergone haploidentical HSCT following day 5 post transplant were randomized to treated group(low-dose glucocorticoid) and controlled group(no intervention).

  Eligibility

Ages Eligible for Study:   up to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • no severe diarrhea no serious infection

Exclusion Criteria:

  • serious diarrhea active,uncontrolled infection
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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)
Study First Received: May 23, 2012
Last Updated: January 3, 2014
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on September 30, 2014