Zanubrutinib Plus Lenalidomide for Frail Elderly Patients With Newly Diagnosed PCNSL
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a prospective, single-arm, phase II clinical study evaluating the efficacy and safety of Zanubrutinib (a BTK inhibitor) plus Lenalidomide (an immunomodulatory drug) in frail elderly patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The study plans to enroll 33 patients who are aged ≥ 70 years and classified as frail, a population for whom standard first-line treatment regimens, high-dose methotrexate-based chemotherapy, may be "unfit". This study includes screening phase, induction phase, consolidation phase and maintenance phase. The screening period is defined as within 1 week prior to the first dose. During induction, participants will receive Zanubrutinib 160 mg orally twice daily continuously and Lenalidomide 25 mg orally once daily on days 1-21 of each 28-day cycle for three cycles. Participants who achieve a partial response (PR) or complete response (CR) after induction will receive three additional 28-day consolidation cycles of the same regimen. Participants who achieve a CR after consolidation will continue maintenance treatment with Zanubrutinib and Lenalidomide until disease progression. Treatment response will be assessed throughout the study using the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria and assessed every 3 months. The primary endpoint is the complete response rate (CRR) at the end of induction therapy. Secondary endpoints include overall response rate (ORR) at the end of induction therapy, CRR and ORR at the end of consolidation therapy, One-year and two-year progression-free survival (PFS) rates, Duration of response (DOR), overall survival (OS), adverse event (AE) and serious adverse event (SAE). Exploratory liquid-biopsy analyses will be performed to evaluate treatment response and prognosis.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 70 lat lub więcej.
- •Pacjent zakwalifikowany jako "osłabiony" na podstawie oceny stanu zdrowia.
- •Zgoda na udział w badaniu i podpisanie świadomej zgody.
- •Ogólny stan zdrowia umożliwiający udział w badaniu (skala ECOG 0-3).
- •Potwierdzony chłoniak z limfocytów B (DLBCL) ograniczony do ośrodkowego układu nerwowego.
- •Wystarczająca praca szpiku kostnego (liczba neutrofili, hemoglobiny, płytek krwi).
- •Wystarczająca praca wątroby i nerek.
- •Należy stosować środki antykoncepcyjne podczas leczenia i przez pewien czas po nim.
✗ Disqualifies
- •Wiek poniżej 70 lat.
- •Pacjent niezakwalifikowany jako "osłabiony" lub w bardzo dobrym stanie zdrowia.
- •Historia innych nowotworów (z wyjątkiem niektórych przypadków).
- •Poważne problemy z sercem, płucami lub innymi narządami.
- •Ciąża lub karmienie piersią.
- •Przyjmowanie pewnych innych leków, które mogą wchodzić w interakcje.
Simplified criteria — AI translation
Trial details
- Minimum age
- 70 Years
- Last updated (source)
- September 28, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Deparment of neurosurgery, Beijing tiantan hospital
Beijing, China
Trial contact
Haoyi Li, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/29/2026.
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