A Phase 2 interventional study of Orelabrutinib in Marginal Zone Lymphoma(MZL), sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment
Among 20 studies testing orelabrutinib in Lymphoma, B-Cell, Marginal Zone — 16 open to participants now, 20 under way, 1 of them phase 3. orelabrutinib · Lymphoma, B-Cell, Marginal Zone.
Among the 20 studies testing orelabrutinib in Lymphoma, B-Cell, Marginal Zone, this one is the 15th largest by planned enrollment, is one of 3 that started in 2026, is one of 16 in phase 2, reaches primary completion later than 19 of the 19 other live ones, and was the 20th registered.
875 studies on the registry are indexed under Lymphoma, B-Cell, Marginal Zone; 111 are open to participants now.
Browse Lymphoma, B-Cell, Marginal Zone studies →16 of the 20 studies testing orelabrutinib in Lymphoma, B-Cell, Marginal Zone are open now, in 1 country. Recruiting first, the newest first:
Zhejiang Cancer Hospital · Sites in China
Ages 18+
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18+
Beijing Tongren Hospital · Sites in China
Ages 18+
The First Affiliated Hospital of Soochow University · Sites in China
Ages 18+
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 18–75
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 92 Lymphoma, B-Cell, Marginal Zone studies recruiting now, 77 (84%) set no upper age limit and 7 (8%) stop at 75 or younger; 9 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2023; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 45 is above the median of 40 across 681 interventional studies indexed under Lymphoma, B-Cell, Marginal Zone.
Median enrollment 51 across the 20 interventional studies. None of them has completed or been terminated yet.
This tab as a report to print or save as PDF → With an account.
1 of 20 have an industry lead sponsor. The 10 most frequent:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 393 studies on the registry; 280 are open to participants now.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences has 3 studies filed under Lymphoma, B-Cell, Marginal Zone — fewer than ten, so there is no comparison to draw.
6 of the studies testing orelabrutinib in Lymphoma, B-Cell, Marginal Zone that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06134284Lixia ShengClinical Study of OR for Second-line Treatment of Refractory MZL | 2026-12-31 |
| NCT06513234Institute of Hematology & Blood Diseases Hospital, ChinaCombination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas | 2027-06-21 |
| NCT06478472The First Affiliated Hospital of Xiamen UniversityProspective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy | 2027-06-23 |
| NCT06504940First Affiliated Hospital of Zhejiang UniversityOptimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL) | 2027-07-08 |
| NCT07022223Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOrelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma | 2027-09-11 |
Add all 6 to your calendar (.ics) → With an account.
Among the 20 studies testing orelabrutinib in Lymphoma, B-Cell, Marginal Zone, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A prospective, multicenter, open-label, phase II trial of PET/CT-guided maintenance therapy in newly diagnosed marginal zone lymphoma. After first-line immunochemotherapy, dual-tracer PET/CT (18F-FDG and 68Ga-Pentixafor) is performed. Patients with Deauville score 4-5 receive orelabrutinib 150 mg daily for 1 year; those with score 1-3 are observed. Primary endpoint: 2-year progression-free survival rate.
Marginal zone lymphoma (MZL) is an indolent B-cell malignancy in which the value of post-induction maintenance therapy remains controversial. This is a prospective, multicenter, open-label, phase II study investigating a PET/CT-guided, response-adapted maintenance strategy in patients with newly diagnosed MZL, including its three subtypes ( extranodal MALT lymphoma, nodal MZL, and splenic MZL). A total of 45 patients will be enrolled (40 evaluable cases, assuming a 10% dropout rate).Patients aged ≥18 years with MZL confirmed per the WHO 2022 lymphoma classification, ECOG performance status 0-2, an indication for systemic treatment per NCCN guidelines, and no prior systemic therapy for MZL (excluding topical and anti-infective treatment) will be eligible. Adequate organ function is required (ANC ≥1.0×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥80 g/dL, TBIL \<1.5×ULN, ALT/AST \<2.5×ULN [\<5×ULN with liver involvement], creatinine clearance ≥40 mL/min). Key exclusions include CNS involvement, prior or concurrent uncontrolled malignancy (except cured basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer), significant cardiovascular disease, and coagulation abnormalities or thromboembolic events within 12 months.First-line immunochemotherapy (e.g., R-CHOP, R-CVP, or bendamustine-rituximab) will be selected by the treating physician according to routine clinical practice; the study does not intervene in treatment decisions. All patients will undergo dual-tracer PET/CT with 68Ga-Pentixafor and 18F-FDG at two mandatory time points: baseline (before first-line therapy) and end of treatment (after completion of planned first-line therapy). Both scans will be performed within 72 hours of each other at Peking Union Medical College Hospital, with randomized imaging order. Images will be independently and blindly interpreted by two experienced nuclear medicine physicians using the Lugano 2014 criteria; 18F-FDG PET/CT will be graded by the 5-point Deauville scale (score 4-5 defined as PET-positive).At the response-assessment and decision point, post-treatment 18F-FDG PET/CT results will guide the subsequent strategy: patients with a positive scan (Deauville 4-5) will receive maintenance therapy with orelabrutinib 150 mg once daily for 1 year, while patients with a negative scan (Deauville 1-3) will be followed with observation alone. The 68Ga-Pentixafor PET/CT results will be used for exploratory diagnostic-performance comparison only and will not influence treatment decisions.After the decision point, all patients will be followed every 3 months (±7 days) by clinic visit or telephone for at least 2 years, or until death, loss to follow-up, or study completion. The primary endpoint is the 2-year progression-free survival (PFS) rate. Secondary endpoints include the sensitivity, specificity, accuracy, and positive/negative predictive values of both tracers at baseline and end of treatment (with ROC analysis using pathology or clinical follow-up as the reference standard); concordance between 18F-FDG and 68Ga-Pentixafor PET/CT (kappa test); adverse events (CTCAE); and overall survival. PFS and OS will be estimated by the Kaplan-Meier method, and survival will be compared between the PET-positive and PET-negative groups using the log-rank test.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥18 years performance status (PS) 0-2 of no less than 12 weeks Marginal zone lymphoma (MZL) confirmed according to the WHO 2022 classification of lymphoid neoplasms, including all three subtypes: splenic MZL, nodal MZL, and extranodal MZL Presence of a treatment indication for MZL per NCCN guidelines, and no prior systemic therapy for MZL (hormonal therapy and anti-infective treatment excepted)
Adequate organ function, as defined by the following criteria (except when attributable to lymphoma involvement):
Hematologic function:
Biochemical function:
Exclusion Criteria:
Central nervous system involvement Prior or concurrent malignant tumor that has not been cured, except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer Presence of any of the following cardiovascular diseases: myocardial ischemia or myocardial infarction of grade II or above, uncontrolled arrhythmia (including ≥450 ms in males and ≥470 ms in females), (NYHA) class III-IV heart failure, or (LVEF) \<50% on echocardiography Coagulation abnormalities ( >1.5, or prothrombin time (PT) > + 4 seconds, or APTT >1.5×ULN), a bleeding tendency, or ongoing thrombolytic or anticoagulant therapy Arterial or venous thromboembolic events within 12 months before enrollment, such as cerebrovascular accidents (including , cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism Known hereditary or acquired bleeding or thrombotic diathesis (e.g., hemophilia, coagulation disorders) Major surgery, severe traumatic injury, fracture, or ulcer within 4 weeks before enrollment Factors that significantly affect the oral absorption of drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction Active infection requiring antimicrobial therapy (e.g., antibacterial or antiviral agents; excluding anti- therapy for chronic hepatitis B and antifungal therapy) Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or (positive anti-HCV antibody with HCV RNA above the lower limit of detection of the assay) History of psychotropic substance abuse that cannot be abstained from, or presence of a psychiatric disorder Known allergy to 68Ga-Pentixafor or 18F-FDG Inability to undergo PET/CT examination for other reasons (e.g., claustrophobia, inability to lie supine) Pregnant or lactating women; patients of who are unwilling or unable to use effective Any other condition that, in the judgment of the investigator, may affect the conduct of the clinical study or the assessment of study results.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Baseline dual-tracer PET/CT with 68Ga-Pentixafor and 18F-FDG will be performed at the Department of Nuclear Medicine, Peking Union Medical College Hospital, before first-line treatment. Patients will then receive standard first-line therapy; upon completion of 6 cycles, both PET/CT scans will be repeated at the same institution. The post-treatment 18F-FDG PET/CT result will determine the subsequent strategy: PET-positive (Deauville 4-5): maintenance therapy with orelabrutinib 150 mg once daily for 1 year; PET-negative (Deauville 1-3): regular follow-up with observation alone. The 68Ga-Pentixafor PET/CT results will be used for comparative analysis only and will not directly influence treatment decisions.
Drug: Orelabrutinib
After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.
24-month progression-free survival rate
Percentage of patients alive and free from disease progression at 24 months (±4 weeks) after enrollment.
Time frame: From enrollment to 24 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2029, 42 months after the start.
Of 97 non-industry phase 2 interventional studies under Lymphoma, B-Cell, Marginal Zone, half reached primary completion within 73 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 117. This study's planned 42 months is below that.
Counting every sponsor, half of 113 studies reached it within 69 months; a quarter within 38 and three quarters within 110.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Orelabrutinib
Lymphoma, B-Cell, Marginal Zone →
Cancer Institute and Hospital, Chinese Academy of Medical Sciences →