Treatment of MALT lymphoma with Orelabrutinib and low-dose radiation
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
This study is testing if a new drug called Orelabrutinib, followed by a low dose of radiation, can effectively treat people with early-stage MALT lymphoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | Orelabrutinib, radiation |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06583837 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Orelabrutinib, a targeted therapy, followed by a response-adapted ultra-low dose of 4Gy radiation as a first-line treatment for local-stage mucosa-associated lymphoid tissue (MALT) lymphoma. It is a prospective, multicenter study that aims to determine how well this combination works in treating patients with this specific type of lymphoma. Participants will receive Orelabrutinib and, based on their response, may subsequently receive radiation therapy tailored to their needs.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed local-stage MALT lymphoma.
Not a fit: Patients with advanced-stage MALT lymphoma or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could provide a more effective and less toxic option for patients with MALT lymphoma.
How similar studies have performed: While there have been studies on targeted therapies for lymphoma, the specific combination of Orelabrutinib and ultra-low dose radiation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Rong Tao — Fudan University
- Study coordinator: Rong Tao
- Email: rtao@shca.org.cn
- Phone: 02164175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.