Prospective Single-Arm Clinical Trial of GO Regimen for HLH.
ConditionLymphohistiocytosis, Hemophagocytic
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age14-70
SponsorBeijing Friendship Hospital
About this trial
This study aims to investigate the efficacy and safety of Golidocitinib(GO) monotherapy in the treatment of hemophagocytic lymphohistiocytosis.
Eligibility criteria
Qualifiers
Researchers evaluate patients with newly diagnosed or refractory/relapsed HLH disease.
Definite diagnosis of HLH: molecular diagnosis consistent with pHLH, or at least 5 of the 8 criteria in the HLH-2004 diagnostic criteria.
Patients who are currently unsuitable or unable to undergo allo-HSCT.
Researchers estimate that the expected survival period exceeds one month.
Disqualifiers
Heart function above grade II(including II) (NYHA).
Pregnancy or lactating Women and reproductive-age patients who refused to use appropriate contraceptive measures during this trial.
Individuals who are allergic to GO or have a severe allergic constitution.
Active bleeding of the internal organs.
Trial design
Treatments tested in this trial
- Golidocitinib
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov