Health TrialsbyHealthPanel

Golidocitinib Combined With Selinexor for CAEBVD

ConditionsLymphohistiocytosisEBVCAEBV
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Friendship Hospital

About this trial

This study is a multicenter, prospective, single-arm clinical investigation, with patients with CAEBVD as the main research subjects, to evaluate the effectiveness of the combined treatment regimen of golidocitinib and selinexor.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

CAEBVD diagnosed in accordance with the Consensus on the Diagnosis and Treatment of Chronic Active Epstein-Barr Virus Disease (2025 Edition).

Aged ≥ 18 years and ≤ 70 years, regardless of gender.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Before the initiation of the study, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN; serum creatinine ≤ 1.5 × ULN.

Disqualifiers

Evidence of EBV-associated hematological diseases or malignancies, such as hemophagocytic lymphohistiocytosis, lymphomatoid granulomatosis, post-transplant lymphoproliferative disorder, non-Hodgkin's lymphoma, Burkitt lymphoma, nasopharyngeal carcinoma, and gastric cancer.

Having received any of the following treatments: prior treatment with any JAK inhibitor; administration of any investigational drug within 12 weeks prior to the first dose of the study drug; concurrent enrollment in another clinical study.

A history of other primary malignancies within 5 years prior to the first dose of the study drug, excluding locally curable malignancies that have received curative treatment (e.g., basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).

A history of organ transplantation (e.g., liver transplantation, kidney transplantation).

Trial design

Design model

Single group

Treatments tested in this trial

  • golidocitinib

    Drug

    golidocitinib 150 mg once daily.

  • Selinexor (combination therapy)

    Drug

    selinexor 40 mg once weekly.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Experimental group:CAEBVDExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Disease Activity

Patients are classified into active and inactive phases based on their clinical symptoms, signs, and laboratory tests.Disease activity is defined as the presence of CAEBVD-related symptoms and signs.

Time frame
Weeks 8 after the start of treatment
2

EBV-DNA

The decline rate of EBV-DNA copy number in peripheral blood mononuclear cells (PBMCs)/plasma (defined as a 2-log reduction in EBV-DNA copy number) or conversion to negative.

Time frame
Weeks 8 after the start of treatment

Secondary outcomes

Other outcomes

1

Survival

The 6-month, 1-year, and 2-year survival rates as well as the median survival time are analyzed.

Time frame
6-month, 1-year and 2-year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov
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