Orelabrutinib combined with rituximab and high-dose methotrexate as induction therapy in newly diagnosed primary central nervous system lymphoma.
Xi-Bin Xiao, Yi-Qin Weng, Hua-Wei Jiang...
https://pubmed.ncbi.nlm.nih.gov/40425940Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID05600660
Orelabrutinib, Rituximab and Methotrexate (OR-MTX) in Newly Diagnosed Primary Central Nervous System Lymphoma: a Single Arm, Multicenter, Phase 2 Study
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2022-11-08
28
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a combination chemotherapy regimen called OR-MTX, which includes Orelabrutinib, Rituximab, and Methotrexate, as the first treatment for patients newly diagnosed with primary central nervous system lymphoma. This phase 2, single-arm, multicenter study plans to enroll 28 patients to better understand how well this regimen works and its side effects. The main goal is to measure the objective response rate, with additional outcomes including progression-free survival, overall survival, and treatment-related adverse events. Participants will receive six cycles of the OR-MTX chemotherapy regimen as induction treatment. After these six cycles, patients who are eligible may undergo autologous hematopoietic stem cell transplantation (AHSCT). Following this, Orelabrutinib will be given as maintenance therapy for up to one year or until disease progression, unacceptable toxicity, death, withdrawal of consent, or loss to follow-up. The study includes a follow-up period lasting up to two years after treatment. During the study, participants will be closely monitored through regular medical assessments, imaging tests such as MRI, and laboratory evaluations to track their response to treatment and watch for side effects. Researchers will evaluate the objective response rate at the end of the six chemotherapy cycles. Safety and other outcomes will be assessed throughout the treatment and follow-up periods. The total participation time may extend up to two years to allow for thorough evaluation of long-term effects and disease control.
CONDITIONS
Brief Title
Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed Primary Central Nervous System lymphoma
- Age between 18 and 75 years old
- Eastern Cooperative Oncology Group performance status of 0 to 3
- No previous treatment except steroid therapy
- Measurable disease of at least 1.0 cm in short diameter by MRI
- Life expectancy of at least 3 months
- Ability and willingness to sign informed consent
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during treatment and for 6 months after
- Men who are sexually active must agree to use effective contraception during treatment and for 6 months after
- Adequate kidney function with estimated GFR or creatinine clearance of at least 50 mL/min and serum creatinine no more than twice the upper limit of normal
- Adequate liver function with transaminases less than 3 times upper normal and bilirubin less than 2 times upper normal
- Adequate blood counts: hemoglobin at least 9 g/dL, neutrophils at least 1,500/μL, and platelets at least 75,000/μL
- Ability to tolerate lumbar puncture and MRI or CT
- Ability to swallow oral medications
You will not qualify if you...
- Lymphoma outside the central nervous system or systemic lymphoma spreading to the CNS
- Current use of other approved or investigational anti-cancer drugs
- Active hepatitis B or C infection, HIV, or other immunodeficiency diseases
- Allergy to study drugs
- Active other cancers requiring treatment
- Significant heart problems including uncontrolled arrhythmias, heart failure, hypertension, valve disease, pericarditis, or recent heart attack
- Uncontrolled active systemic infections
- Life-threatening illness or organ dysfunction that would increase risk
- Pregnant or nursing women
- Unable to participate in all study evaluations and procedures
- Drug abuse or medical, psychological, or social conditions interfering with study participation
- History of recent serious brain bleeding or stroke
- Significant gastrointestinal disease affecting oral drug absorption
- Use of warfarin or similar blood thinners within 7 days before starting study drug
- Use of moderate or strong CYP3A enzyme inhibitors or inducers
- Known bleeding disorders or active bleeding
- History of invasive fungal infection or active tuberculosis
- Considered unsuitable for the study by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment - Induction Chemotherapy
Duration - Approximately 18 weeks (6 cycles of 21 days each)
Participants receive 6 cycles of induction chemotherapy with Orelabrutinib, Rituximab, and Methotrexate.
6 visits every 3 weeks (in-person)
Autologous Hematopoietic Stem Cell Transplantation (AHSCT)
Duration - Variable based on eligibility
Participants eligible for transplantation undergo autologous hematopoietic stem cell transplantation after induction chemotherapy.
1 visit (in-person) for transplantation and immediate care
Treatment - Maintenance Chemotherapy
Duration - Up to 1 year
Participants receive daily Orelabrutinib maintenance chemotherapy for up to one year or until disease progression, intolerable toxicity, death, withdrawal, or loss to follow-up.
Monthly visits during maintenance treatment (in-person)
Follow-up
Duration - Up to 2 years
Participants are monitored for safety and disease progression for up to 2 years after treatment.
Periodic visits during follow-up (in-person or remote as per protocol)
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, China, 310009
Actively Recruiting
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Research Team
W
Wenbin Qian, prof.
X
Xianggui Yuan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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