ClinicalTrials.gov record NCT07270835

Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma

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

The Study of Zanubrutinib Combined With Rituximab in the Treatment of Secondary Hemophagocytic Lymphohistiocytosis in B-cell Lymphoma

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 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.
Age14 years old to 80 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 Phase 4, single-group study gives zanubrutinib (oral) together with rituximab (IV) to people with HLH linked to B‑cell lymphoma. Prednisone, ruxolitinib and optionally emapalumab may also be used alongside the main drugs. The study measures HLH response after 4 weeks and overall survival at 8 weeks, and tracks adverse events.

What it is studying. The study tests the combination of zanubrutinib and rituximab (often given with prednisone, ruxolitinib and possibly emapalumab) as a treatment for secondary HLH occurring with B‑cell lymphoma, focusing on HLH response and short-term survival and monitoring safety.

What the researchers hope to learn. Determine HLH response rate after 4 weeks; measure overall survival at 8 weeks and at later timepoints; assess safety and adverse events of the drug combination.

What this study is about

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

For patients who met the inclusion criteria, treatment regimens were administered: Rituximab 375 mg/m², intravenously, once weekly for 4 weeks. Zanubrutinib 160 mg, orally, twice daily for 4 weeks. Combined drugs: prednisone 100 mg/m²/d, orally, d1-5; Ruxolitinib 15mg bid orally; With/without emapalumab as appropriate.

Interventions being studied

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

Drug
  • Rituximab
  • Zanubrutinib

Eligibility

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

Inclusion criteria

  • According to the diagnostic criteria of HLH-04, the patients meet the diagnostic criteria of HLH;
  • HLH patients with definite or highly suspected evidence of B-cell lymphoma; Or HLH patients whose bone marrow flow cytometry show an increased proportion of CD20-positive B cells;
  • Age of 14-80 years old, both sexes;
  • Predicted survival beyond 1 month;
  • Baseline serum creatinine ≤1.5 times ULN; Fibrinogen could be corrected to ≥0.6g/L by infusion;
  • Negative serum HIV antibody; Either negative for HCV antibodies or positive for HCV antibodies but negative for HCV RNA. HBV surface antigen and HBV core antibody were negative. If any of the above was positive, HBV DNA titer in peripheral blood should be tested, and the titer was less than 1×10\^3 copies /ml;
  • Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiography;
  • The patient have no serious and uncontrollable infections, such as pulmonary infection, intestinal infection, and sepsis;
  • Women of childbearing age must be confirmed to be not pregnant by pregnancy test and willing to take effective measures to prevent pregnancy during the study period and ≥12 months after the last dose; Pregnant and lactating women cannot participate; All male subjects took contraceptive measures during the trial and ≥3 months after the last dose;
  • Patients should be able to sign informed consent.

Exclusion criteria

  • Patients with known severe allergy to rituximab, zanubrutinib, or other BTK inhibitors;
  • Severe active infections (including bacterial, viral or fungal infections) or uncontrolled co-infections;
  • Severe organ dysfunction including NYHA class III-IV heart failure or severe arrhythmia; Liver function: ALT or AST >5 times the upper limit, or severe cirrhosis; Renal function: CrCl <30 mL/min or severe renal insufficiency;
  • Combined with other malignant tumors and the expected survival time was less than 3 months;
  • Have received other experimental drugs and had not completed the drug washout period;
  • Pregnant or lactating women, or unwilling to use effective contraception;
  • any condition that would not be suitable for participation in the study or that might affect adherence, follow-up, or safety assessment, as judged by the investigator.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

For patients who met the inclusion criteria, treatment regimens were administered: Rituximab 375 mg/m², intravenously, once weekly for 4 weeks (may be extended or adjusted according to clinical response). Zanubrutinib: 160 mg, orally, twice daily for 4 weeks as for rutuximab. Dose can be adjusted or extended according to tolerance and efficacy. When ≥3 grade hematological or intolerable non-hematological toxicity occur, zanubrutinib or rituximab will be suspended, and the dose will be reduced or resumed according to the toxicity grade after recovery. The dose of zanubrutinib should be adjusted according to the manufacturer's label with concomitant use of strong CYP3A inhibitor/inducer. Combined drugs: prednisone 100 mg/m²/d, orally, d1-5; Ruxolitinib 15mg bid orally; With/without emapalumab as appropriate.

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 treatment: rituximab by IV once weekly for about 4 weeks and zanubrutinib orally twice daily for about 4 weeks; prednisone (oral, short course), ruxolitinib (oral), and possibly emapalumab may also be given as appropriate. Doses may be adjusted, paused, or extended based on side effects or clinical response; zanubrutinib dosing will follow manufacturer guidance when interacting drugs are used. Screening and on-study checks include blood testing, pregnancy testing, heart-function assessment (LVEF), and potentially bone marrow testing for CD20+ cells; safety monitoring for adverse events will occur during treatment. Participation involves regular clinic visits for infusions, drug dispensing, and monitoring; procedures and frequency are determined by the study team and the participant's condition.

How the study is structured. Interventional Phase 4, single-group (all participants receive the same treatment), open-label study. Participants receive rituximab intravenously once weekly and zanubrutinib orally twice daily around a 4‑week treatment period; doses may be adjusted for tolerance. The team evaluates HLH response at 4 weeks, overall survival at set timepoints (including week 8), and records adverse events using standard grading.

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
Nov 1, 2025
Primary completion
April 2027 (estimated)
Study completion
August 2027 (estimated)
Target enrollment
40 participants (estimated)
Last updated on registry
Dec 8, 2025
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
The First Affiliated Hospital of Soochow University
Principal investigator
Xuefeng He, professor
The First Affiliated Hospital of Soochow University

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.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

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.
prednisone
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
Baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
ULN
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.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
CrCl
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
washout period
A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
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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