Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma
- Conditions
- Lymphoma, B-Cell, Marginal Zone
- Interventions
- Radiation: response-adapted radiation
- Registration Number
- NCT06583837
- Lead Sponsor
- Fudan University
- Brief 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
- Detailed Description
This prospective, multicenter trial is trying to evaluate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation as first-line treatment of local-stage mucosa associated lymphoid tissue extranodal marginal zone lymphoma
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation Orelabrutinib Orelabrutinib was administrated for 12 weeks, followed by response-adapted ultra-low dose 4Gy radiation for local stage MALT EMZL Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation response-adapted radiation Orelabrutinib was administrated for 12 weeks, followed by response-adapted ultra-low dose 4Gy radiation for local stage MALT EMZL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 6-months CR rate up to 6 months the ratio of numbers of patients with complete response to all the participants receiving treatment
2-year event-free survival (EFS) From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years the period from the date of patients sign informed consent to the observed event for any reason
2-year progression-free survival (PFS) From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
2-year overall survival rate From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Throughout the treatment period, up to 1 year Record the name of adverse events and number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Quality of life questionnaire(EORTC QLQ-C30) Up to 1 year evaluate patients' quality of life by questionnaire using EORTC QLQ-C30.There are a total of 30 entries. Among them, items 29 and 30 are divided into seven levels, ranging from 1 to 7 points based on their answer options; The other items are divided into four levels: none, a little, many to many, and are rated directly on a scale of 1 to 4.
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China