Lymphoma, B-Cell, Marginal Zone
Conditions
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
Interventions
DRUGOrelabrutinib
Orelabrutinib was administrated for 12 weeks
RADIATIONresponse-adapted radiation
response-adapted ultra-low dose 4Gy radiation
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORRong Tao
Fudan University
Outcome results
None listed