Ruxolitinib as GVHD Prophylaxis in AA Patients (NCT05914714) | Clinical Trial Compass
UnknownPhase 2
Ruxolitinib as GVHD Prophylaxis in AA Patients
46 participantsStarted 2023-07-01
Plain-language summary
Our study aimed to determine the prophylactic value of ruxolitinib for aGVHD in HSCT recipients of AA.Ruxolitinib was initiated at the beginning of conditioning regimen at 5 twice daily until 3 months post-transplantation. The cumulative incidence of aGVHD within 6 months after HSCT will be the primary observation item.
Who can participate
Age range14 Years
SexALL
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Inclusion Criteria:
* (1) diagnosed as aplasitic anemia, including V/SAA,CAA and HAAA. (2) Age elder than or equal to 14 years; (3) Informed consent may be signed by themselves. (4) HIV negative, HBV, HCV negative; (5) Informed consent must be signed before the start of the study procedures, and informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member
Exclusion Criteria:
* (1) received a previous allogeneic HSCT; (2) Uncontrolled infection at enrollment; requires mechanical ventilation or is hemodynamically unstable at the time of enrollment; (3) has severe hepatic insufficiency (defined as Child-Pugh Class C; has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 xthe upper limit of normal (ULN) or serum total bilirubin \> 2.5 x ULN.
(4) has end-stage renal impairment with a creatinine clearance less than 10 mL/min.
(5) has both moderate hepatic insufficiency AND moderate renal insufficiency; (6) has documented positive results for human immunodeficiency virus antibody (HIVAb), hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollments; (7) has active solid tumor malignancies with the exception of localized basal cell or squamous cellā¦
What they're measuring
1
cumulative incidence of aGVHD
Timeframe: 6 months post-HSCT
Trial details
NCT IDNCT05914714
SponsorInstitute of Hematology & Blood Diseases Hospital, China