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New treatment option for Lymphohistiocytosis, Hemophagocytic
Official title Prospective Single-Arm Clinical Trial of GO Regimen for HLH.
ClinicalTrials.gov ID: NCT07339345
What this study is testing
What is Golidocitinib?
Golidocitinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for lymphohistiocytosis, hemophagocytic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to investigate the efficacy and safety of Golidocitinib(GO) monotherapy in the treatment of hemophagocytic lymphohistiocytosis.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 70
You may be able to join if
- 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.
- Patients must be at least 14 years of age and no older than 70 years of age, with no gender restrictions.
You likely can't join if
- 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.
- uncontrollable infection.
- Severe mental illness.
See the full eligibility criteria
- 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.
- Patients must be at least 14 years of age and no older than 70 years of age, with no gender restrictions.
- Before the study began, TB was ≤10 times the upper limit of normal; Cr was ≤1.5 times the normal value.
- Serum HIV antigen or antibody negative。
- HCV antibody negative, or HCV antibody positive but HCV RNA negative.
- .HBsAg and HBcAb are both negative. If either of the above is positive, peripheral blood hepatitis B virus DNA titer testing is required, with a titer of less than 1×10³ copies/ml.
- Echocardiography showed LVEF ≥ 50%.
- Women of childbearing age must be confirmed as not pregnant by a pregnancy test and must be willing to use effective contraception during the study period and for at least 12 months after the last dose; all male...
- 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.
- uncontrollable infection.
- Severe mental illness.
- History of non-melanoma skin cancer.
- Unable to comply during the trial and/or follow-up phase. Participate in other clinical research at the same time.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.