Liping Dou
Beijing, Beijing Municipality, 100853, China
NCT Number: NCT02677181
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).
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Notify Me40 year–70 year
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100853, China
Transplantation with G-CSF (Granulocyte colony stimulating factor )mobilized peripheral blood stem cell (PBSCT) has been a stable transplant setting with matched sibling donor transplantation. Unmanipulated haploidentical donor PBSCT (haplo-PBSCT) has been applied in patients with hematologic malignancies. In our previous cohort study, haplo-PBSCT was associated with lower incidence of severe acute GVHD and extensive chronic GVHD compared with matched sibling donor PBSCT (MSD-PBSCT). Haplo-PBSCT has the same GVHD prophylaxis regimen with MSD-PBSCT, except ATG. It suggested the potential advantage of ATG in prophylaxis of GVHD and improvement of long-term quality of life of the transplant recipients, which motivate us to observe the efficacy of combined ATG regimen for GVHD prophylaxis in MSD-PBSCT.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
rabbit ATG(Sanofi)
Other names: Thymoglobuline
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.
Other names: Neoral/Sandimmun
From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30 for MSD-PBSCT.
Other names: MMF(Novartis)
short-term methotrexate
Other names: MTX(Pfizer)
Time frame: three years
Chronic graft versus host disease grading criteria (refer to NIH criteria)
Time frame: two years
Time frame: two years
Time frame: two years
disease-free survival
Time frame: two years
treatment-related mortality
Time frame: three months
Chinese PLA General Hospital
Other
Prospective Study of Combined ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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