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

NCT06583837 | Active Not Recruiting Phase 2

• 1 other identifier: iNHL-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphoma, B-Cell, Marginal Zone

Outcome Measures

Primary Outcomes (1)

• 1-year event-free survival (EFS)

  the period from the date of patients sign informed consent to the observed event for any reason

  1 year

Secondary Outcomes (6)

• 6-months CR rate

  up to 6 months

• 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

• 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

• 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

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Throughout the treatment period, up to 1 year

Study Arms (1)

Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation

EXPERIMENTAL

Orelabrutinib was administrated for 12 weeks, followed by response-adapted ultra-low dose 4Gy radiation for local stage MALT EMZL

Drug: Orelabrutinib; Radiation: response-adapted radiation

Interventions

Orelabrutinib DRUG

Orelabrutinib was administrated for 12 weeks

Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation

response-adapted radiation RADIATION

response-adapted ultra-low dose 4Gy radiation

Also known as: radiation

Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

orelabrutinib; Radiation

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Rong Tao

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 4, 2024
• Study Start: September 10, 2024
• Primary Completion: August 18, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)