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Active, not recruiting Phase 2

Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma

NCT06583837 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2024-09-10
Last updated
2026-02-27

Condition(s) studied

Lymphoma, B-Cell, Marginal Zone

Investigational drug(s) / intervention(s)

Orelabrutinib →response-adapted radiation

Orelabrutinib: Orelabrutinib was administrated for 12 weeks

response-adapted radiation: response-adapted ultra-low dose 4Gy radiation

Study summary

Investigate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation in the treatment of local-stage MALT lymphoma

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years old * Histologically confirmed mucosa-associated lymphoid tissue (MALT) lymphoma * Lugano stage I-II * ECOG 0-2 * Signed informed consent * Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 109/L, PLT ≥ 50 × 109/L, Hb ≥ 80g/L; b) Liver function: bilirubin ≤1.5 times the upper limit of normal (ULN), ALT and AST\<3 x ULN, serum albumin ≥ 30 g/L; c) Renal function: serum Cr\<1.5 × ULN, creatinine clearance rate ≥ 50mL/min (calculated according to the standard Cockcroft Gault formula, if renal dysfunction is caused by tumor compression, creatinine clearance rate ≥ 30mL/min); d) Coagulation function (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at the time of screening): International standardized ratio (INR) ≤ 1.5 x ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN. Exclusion Criteria: * Recent major surgery (within 4 weeks prior to enrollment), except for diagnostic surgery * Have uncontrolled intercurrent diseases (cardiovascular and cerebrovascular diseases, coagulation disorders, severe infectious diseases) including but not limited to: severe acute or chronic infection requiring systemic treatment, symptomatic congestive heart failure (NYHA III-IV) or symptomatic or poorly controlled arrhythmias, arterial hypertension (systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥100mmHg) that is not controlled even with standard treatment, unstable angina, active peptic ulcer or bleeding disorder; * Severe concomitant diseases that interfere with treatment * Active interstitial pneumonia * Active chronic hepatitis B infection (defined as HBV DNA positive; patients with latent or prior hepatitis B infection (defined as positive for hepatitis B surface antigen or hepatitis B core total antibody) can be included if HBV-DNA is undetectable at screening. The above-mentioned patients must voluntarily undergo regular DNA tests and receive appropriate antiviral therapy as prescribed) * Positive hepatitis C test result (for patients who are positive for HCV antibodies, only polymerase chain reaction (PCR) shows a negative HCV RNA can participate) * Patients with active HIV and syphilis infections; * Pregnant or lactating women * Patients with multiple factors affecting oral medication (such as dysphagia, nausea, vomiting, chronic diarrhea, and intestinal obstruction) * The researcher determined that patients are not suitable to participate in this study.

Primary outcome measure(s)

  • 1-year event-free survival (EFS) — 1 year
    the period from the date of patients sign informed consent to the observed event for any reason

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06583837 on ClinicalTrials.gov ↗ ← All trials in China