Who may be eligible for the Prospective Single-Arm Clinical Trial of GO Regimen for HLH. trial?

Inclusion Criteria: 1. Researchers evaluate patients with newly diagnosed or refractory/relapsed HLH disease. 2. Definite diagnosis of HLH: molecular diagnosis consistent with pHLH, or at least 5 of the 8 criteria in the HLH-2004 diagnostic criteria. 3. Patients who are currently unsuitable or unable to undergo allo-HSCT. 4. Researchers estimate that the expected survival period exceeds one month. 5. Patients must be at least 14 years of age and no older than 70 years of age, with no gender restrictions. 6. Before the study began, TB was ≤10 times the upper limit of normal; Cr was ≤1.5 times the normal value. 7. Serum HIV antigen or antibody negative。 8. HCV antibody negative, or HCV antibody positive but HCV RNA negative. 9. .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. 10. Echocardiography showed LVEF ≥ 50%. 11. 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 participants must use contraception during the study period and for at least 3 months after the last dose. Exclusion Criteria: 1. Heart function above grade II(including II) (NYHA). 2. Pregnancy or lactating Women and reproductive-age patients who refused to use appropriate contraceptive measures during this trial. 3. Individuals who are allergic to GO or have a severe allergic constitution. 4. Active bleeding of the internal organs. 5. uncontrollable infection. 6. Severe mental illness. 7. History of non-melanoma skin cancer. 8. Unable to comply during the trial and/or follow-up phase. Participate in other clinical research at the same time.

ClinicalTrials.gov record NCT07339345

Prospective Single-Arm Clinical Trial of GO Regimen for HLH.

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Prospective Single-Arm Clinical Trial of Golidocitinib Monotherapy for Hemophagocytic Lymphohistiocytosis.

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2/3A study that tests whether a treatment works while continuing to check safety, in a larger group than a phase 2 study alone. It combines the aims of phase 2 and phase 3 in one protocol.

Age14 years old to 70 years old

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a single-group, open-label Phase 2/3 trial testing Golidocitinib (GO) given at 150 mg once daily for people with newly diagnosed or relapsed/refractory hemophagocytic lymphohistiocytosis who are unsuitable for allo‑HSCT. The study will evaluate response to treatment at several early time points and record treatment-related adverse events. All participants receive the same study drug; there is no placebo or comparison group.

What it is studying. The study is testing whether Golidocitinib given alone produces measurable clinical and laboratory responses in people with HLH and is collecting safety information. Response is assessed using HLH-related signs and lab markers (for example ferritin, sCD25, triglycerides, blood counts, and hemophagocytosis) at defined weeks after starting treatment. The study also tracks adverse events and serious adverse events during and after treatment.

What the researchers hope to learn. To measure how often Golidocitinib produces complete or partial responses in HLH using standard HLH response measures, and to collect information about treatment-related adverse events.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This study aims to investigate the efficacy and safety of Golidocitinib(GO) monotherapy in the treatment of hemophagocytic lymphohistiocytosis.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Golidocitinib

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion 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 participants must use contraception during the study period and for at least 3 months after the last dose.

Exclusion criteria

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive golidocitinib 150 mg once daily and attend regular clinic visits for treatment and safety checks. Visits include blood tests and clinical assessments of HLH markers and symptoms at about weeks 2, 4, 6 and 8 to evaluate response (markers listed in the study include sCD25, ferritin, triglycerides, blood counts, hemophagocytosis and level of consciousness if CNS HLH is present). Screening and on‑study tests include baseline heart ultrasound (echocardiography), viral tests (HIV, HCV, hepatitis B), liver and kidney tests, and pregnancy testing as required; contraception requirements apply. Safety monitoring for treatment‑related adverse events continues, with adverse‑event assessment extending to 30 days after the last dose.

How the study is structured. Interventional, single-group, open-label Phase 2/3 trial: every participant receives Golidocitinib 150 mg once daily. Responses are evaluated at specified times early in treatment (weeks 2, 4, 6, and 8) and safety is monitored, with adverse events assessed through 30 days after the last dose.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on hemophagocytic lymphohistiocytosis

Clinical trials34 trials listed for hemophagocytic lymphohistiocytosisEvery trial the registry lists for hemophagocytic lymphohistiocytosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hemophagocytic lymphohistiocytosis researchLatest monthly update: September 2026. Includes: Multiple test results. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jun 27, 2025
Primary completion: Jun 27, 2026 (estimated)
Study completion: Jun 27, 2027 (estimated)
Target enrollment: 28 participants (estimated)
Last updated on registry: Jan 14, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Beijing Friendship Hospital
Principal investigator: Zhao Wang, Doctor
Beijing Friendship Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

jingshi Wang, M.M. 📞 86-13520280731 ✉ wangjingshi987@126.com

Participating sites (1)

beijing Friendship Hospital, Capital Medical UniversityRecruiting
Beijing, Beijing Municipality, 100050 · China
- jingshi Wang, M.M. · 86-13520280731 · wangjingshi987@126.com

Terms used on this page · explanations by MedicalUpdates.ai

refractory: A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
relapsed: A condition that improved with treatment and has since returned or worsened.
allo-HSCT: A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
upper limit of normal: The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Echocardiography: An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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