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Efficacy and Safety Study of ATG for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

NCT02677181 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-05-24

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of combined ATG （antithymocyte globulin ） regimen for aGVHD(acute graft-versus-host disease ) prophylaxis in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).

Conditions

  • aGVHD

Interventions

DRUG

ATG

rabbit ATG（Sanofi）

DRUG

CsA

cyclosporine (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered.

DRUG

mycophenolate mofetil

From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30 for MSD-PBSCT.

DRUG

Methotrexate

short-term methotrexate

Sponsors & Collaborators

  • 309th Hospital of Chinese People's Liberation Army

    collaborator OTHER

  • Beijing Naval General Hospital

    collaborator OTHER

  • Space Center Hospital, Peking University

    collaborator UNKNOWN

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Daihong Liu, Doctor · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-01-31
Completion
2022-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02677181 on ClinicalTrials.gov