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New treatment option for Hemophagocytic Lymphohistiocytosis
Official title Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma
ClinicalTrials.gov ID: NCT07270835
What this study is testing
What is Rituximab?
Rituximab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for hemophagocytic lymphohistiocytosis.
Also referred to as HALPRYZA.
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
- 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.
- Phase 4: studies an already-approved treatment
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 80
You may be able to join if
- 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...
- 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;
You likely can't join if
- 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...
- 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;
See the full eligibility 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...
- 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...
- Patients should be able to sign informed consent.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, 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.