Actively Recruiting
A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-08-15
43
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, single-arm, open Phase Ib/II clinical study to explore the safety and efficacy of pomadomide in combination with rituximab and methotrexate (RPM) in newly diagnosed primary central nervous system lymphoma (PCNSL) subjects. The Phase I study is a dose escalation study, in which rituximab and methotrexate are fixed doses, and pomadomide is set into 3 dose groups: 3mg/d, 4mg/d and 5mg/d. In strict accordance with the "3+3" dose escalation principle, 3-6 subjects are to be recruited in each dose group, and each subject is to be observed for 1 cycle after treatment to determine MTD. Phase II study: RP2D is planned to be determined based on the Phase Ib study, with an additional 25 active participants enrolled to further evaluate efficacy and safety. Subjects with initial treatment of PCNSL who met the inclusion/exclusion criteria were screened, and after signing the informed consent letter, they received 4 courses of PRM regimen. The patients achieving CR or PR were consolidated by autologous transplantation consolidation regimen or the original regimen for 2 courses, and then were given pomadomide maintenance therapy for 12 cycles. Follow-ups should be taken up to the first 3 years.
CONDITIONS
Official Title
A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL).
- Lesions confined to the central nervous system including brain, spinal cord, eyes, and meninges.
- No involvement outside the central nervous system confirmed by physical exam, imaging, and bone marrow biopsy.
- No prior chemotherapy or radiotherapy except dexamethasone less than 10mg/day for less than 5 days.
- Age between 18 and 75 years inclusive.
- Eastern Cooperative Oncology Group performance status of 0 to 3.
- Measurable disease of at least 1.0 cm in short diameter by enhanced MRI.
- Life expectancy of at least 3 months as judged by the investigator.
- Ability to understand and sign informed consent.
- Willingness and ability to follow up on schedule and complete the trial.
- Women of reproductive potential must agree to use highly effective birth control during treatment and for 6 months after last dose.
- Men who are sexually active must agree to use highly effective contraception during treatment and for 6 months after last dose.
You will not qualify if you...
- Presence of systemic lymphoma disease.
- Prior systemic or local treatment such as chemotherapy, radiotherapy, or stem cell transplantation.
- History of other malignant tumors requiring active therapy.
- Chronic or active infections needing systemic antibiotic, antifungal, or antiviral treatment (except EBV infections).
- Uncontrolled cardiovascular, cerebrovascular, bleeding, thrombotic, connective tissue, or other diseases.
- Other uncontrolled diseases deemed unsuitable by researchers.
- Abnormal laboratory values at screening (unless due to lymphoma): low white blood cells, neutrophils, platelets, hemoglobin; elevated liver enzymes, bilirubin, or creatinine.
- Active hepatitis B or C infection or immunodeficiency diseases including HIV.
- Pregnant or lactating women.
- History of drug abuse.
- Mental illness or inability to comply with study protocol.
- Known allergy to study drugs or ingredients.
- Inability to swallow capsules or severe gastrointestinal conditions.
- Inability to undergo enhanced MRI.
- Other reasons making participation unsuitable as judged by researchers.
AI-Screening
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
X
Xianggui Yuan, Doctor
CONTACT
W
Wenbin Qian
CONTACT
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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