Clinical trial · Interventional
Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma
A Prospective, Multicenter, Phase II Study 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
NCT06583837CI-TRIAL-00104181active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Investigate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation in the treatment of local-stage MALT lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell, Marginal Zone | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orelabrutinib | Drug | — | UNRESOLVED |
| response-adapted radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation
- description
- Orelabrutinib was administrated for 12 weeks, followed by response-adapted ultra-low dose 4Gy radiation for local stage MALT EMZL
- interventionNames
- Drug: Orelabrutinib
- Radiation: response-adapted radiation
Primary outcomes (1)
- measure
- 1-year event-free survival (EFS)
- timeFrame
- 1 year
- description
- the period from the date of patients sign informed consent to the observed event for any reason
Secondary outcomes (6)
- measure
- 6-months CR rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.