Actively Recruiting
Orelabrutinib, Sintilimab and Temozolomide in Relapsed or Refractory Central Nervous System Lymphoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-07-31
19
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
S
Sir Run Run Shaw Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial is evaluating the efficacy and side effect of orelabrutinib, sintilimab and temozolomide as possible treatments for relapsed or refractory central nervous system lymphoma.
CONDITIONS
Official Title
Orelabrutinib, Sintilimab and Temozolomide in Relapsed or Refractory Central Nervous System Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary CNS lymphoma or secondary diffuse large B-cell lymphoma limited to CNS
- Disease that has relapsed or is refractory after at least one prior methotrexate-based therapy
- Age 18 to 75 years at time of informed consent
- Ability and willingness to sign informed consent
- Willingness and ability to follow study visits, treatments, and lab tests
- Evidence of measurable or evaluable enhancing disease on MRI for PCNSL subjects
- Availability of 10 to 20 unstained tissue slides from initial or recent biopsy for research
- ECOG performance status between 0 and 3
- Life expectancy greater than 3 months by investigator's opinion
- Stable, recovered toxicities from prior therapy to Grade 1 or less
- Ability to tolerate lumbar puncture and MRI/CT scans
- Adequate organ function including ANC ≥ 1.0 x 10^9/L, platelets ≥ 75 x 10^9/L, coagulation tests less than 2 times normal, liver enzymes less than 2.5 times normal, bilirubin ≤ 1.5 times normal, and creatinine clearance > 30 mL/min
- Women of child-bearing potential must use effective contraception during and 120 days after treatment
- Male participants must use contraception during treatment and 120 days after last dose
- Ability to swallow oral medications
You will not qualify if you...
- CNS lymphoma with systemic disease
- Pathological diagnosis of T-cell lymphoma
- Chemotherapy within 4 weeks, targeted therapy within 2 weeks, antibody-drug conjugates within 10 weeks, or autologous stem cell transplant within 6 months prior to study treatment
- Prior allogeneic stem cell transplant
- Participation in another investigational clinical trial within 4 weeks prior to study treatment
- External beam radiation therapy to CNS within 14 days before study treatment
- Requirement of more than 8 mg daily dexamethasone or equivalent at study start, unless tapered within 14 days
- History of intracranial hemorrhage or significant stroke within 6 months prior to study
- Significant gastrointestinal disease affecting oral drug absorption
- Active cancer requiring therapy other than lymphoma
- Prior treatment with checkpoint inhibitors or BTK inhibitors
- Use of warfarin or related anticoagulants within 7 days prior to study drug; low molecular weight heparin or novel anticoagulants allowed
- Concurrent use of moderate or strong CYP3A inhibitors or inducers
- Receipt of live attenuated vaccine within 30 days prior to study; no live vaccines during and 30 days after treatment
- Suspected or confirmed progressive multifocal leukoencephalopathy
- Active autoimmune disease requiring systemic treatment within 2 years, except certain controlled conditions
- Significant medical diseases increasing risk, including recent heart attack, unstable angina, uncontrolled diabetes, active infections, severe immunosuppression, or severe heart failure
- Known bleeding disorders or active bleeding
- Known HIV infection
- Active hepatitis B or C infection
- History of invasive fungal infections or active tuberculosis
- Major surgery within 6 weeks prior to study or planned surgery within 2 weeks after first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
W
Wenbin Qian, Prof.
CONTACT
X
Xianggui Yuan, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here