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New drug cocktail aims to tame deadly immune storm in lymphoma

NCT ID NCT07270835

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two drugs, zanubrutinib and rituximab, for people with B-cell lymphoma who develop a severe immune overreaction called hemophagocytic lymphohistiocytosis (HLH). The trial will enroll 40 participants and aims to see how well the treatment controls HLH after 4 weeks. The approach adds targeted therapy to standard care, potentially offering a new way to manage this dangerous complication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zanubrutinib and rituximab
What this could lead to
If successful, this combination could offer a new treatment option for a rare and life-threatening complication of B-cell lymphoma.
What could go wrong
This is a small, early-phase trial with only 40 participants. The treatment may not work for everyone, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, China

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