Management and outcome of primary CNS lymphoma in the modern era: An LOC network study.
Caroline Houillier, Carole Soussain, Hervé Ghesquières...
https://pubmed.ncbi.nlm.nih.gov/31907289Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID07002099
Selinexor, High-dose Methotrexate, and Rituximab Combined With Radiotherapy for Newly Diagnosed, Transplant-ineligible Patients With Central Nervous System Lymphoma: An Open-label, Single-arm, Multicenter Phase II Study
Led by Second Affiliated Hospital of Soochow University · Updated on 2025-06-03
26
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment combination for patients newly diagnosed with central nervous system lymphoma (CNSL) who cannot undergo stem cell transplantation. This phase II trial is designed to study the safety and effectiveness of combining selinexor, an oral drug that blocks nuclear export, with high-dose methotrexate and rituximab chemotherapy. After chemotherapy, patients may receive low-dose whole-brain radiotherapy. The goal is to find a less toxic and potentially more effective treatment for older or medically unfit patients with CNSL. Participants will receive up to six cycles of treatment every 21 days. Each cycle includes rituximab given intravenously on day 0, high-dose methotrexate intravenously on day 1, and selinexor taken orally once a week on days 1, 8, and 15. Tumor response is checked every three cycles. Those who respond will then receive low-dose radiotherapy to the whole brain, followed by maintenance treatment with selinexor taken weekly until disease progression or unacceptable side effects occur. During the study, patients will undergo regular evaluations to monitor tumor response, side effects, and overall health. The primary outcome is the overall response rate to treatment over two years. Researchers will also track how long the response lasts, overall survival, and treatment safety. The total participation period may extend as long as patients continue maintenance therapy or until disease progression. This open-label, single-arm trial involves multiple centers and aims to provide new options for patients ineligible for stem cell transplantation.
CONDITIONS
Brief Title
Selinexor, High-dose Methotrexate, and Rituximab Combined With Radiotherapy for Newly Diagnosed, Transplant-ineligible Patients With Central Nervous System Lymphoma: An Open-label, Single-arm, Multicenter Phase II Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically confirmed primary or secondary CNS lymphoma with CNS-only involvement
- Not eligible for autologous stem cell transplantation or declined transplantation
- At least one measurable brain lesion 1 cm or larger, or positive cerebrospinal fluid cytology/flow cytometry for leptomeningeal disease
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3
- Adequate organ function including specific blood counts, liver and kidney function, and coagulation parameters
- Estimated life expectancy of at least 3 months
- Negative pregnancy test for women of childbearing potential
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- CNS involvement limited only to intraocular lymphoma
- Prior systemic therapy for CNS lymphoma
- Secondary CNS lymphoma with active systemic disease outside the CNS
- Uncontrolled high pressure in the brain (intracranial hypertension)
- Significant or unstable heart conditions including recent heart attack, unstable angina, uncontrolled arrhythmias, severe heart failure, or low heart pumping function
- Other severe uncontrolled medical conditions including active infections needing systemic treatment
- Known active infections with hepatitis B, hepatitis C, or HIV
- Active gastrointestinal problems that affect swallowing or absorbing oral drugs
- Prior treatment with selective inhibitor of nuclear export compounds including selinexor
- Concurrent cancers except certain treated skin, bladder, cervical, prostate, or breast cancers
- Pregnant or breastfeeding women or those unwilling to use effective contraception during and after the study
- Any condition making the patient unsuitable for study participation as judged by the investigator
AI-Screening
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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
Duration - Approximately 18 weeks (6 cycles of 21 days each)
Participants receive combination therapy including rituximab and high-dose methotrexate intravenously every 21 days for up to 6 cycles, along with oral selinexor once weekly during each cycle. Tumor response is evaluated every 3 cycles.
6 treatment cycles with multiple visits per cycle including Day 0 and Day 1 infusions and weekly oral dosing visits
Treatment
Duration - Approximately 2 to 3 weeks
Participants who achieve at least a partial response proceed to consolidative low-dose whole-brain radiotherapy (WBRT) delivered in 13 fractions.
13 visits (in-person radiotherapy sessions)
Treatment
Duration - Variable duration until disease progression or unacceptable toxicity
After radiotherapy, participants who maintain a response continue maintenance treatment with oral selinexor once weekly until disease progression, unacceptable toxicity, or withdrawal.
Weekly visits for oral medication monitoring
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215000
Actively Recruiting
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Research Team
B
Bingzong Li
Y
Yuchen Zhang
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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Published Research Related To This Trial
Selinexor for advanced hematologic malignancies.
Janek S Walker, Ramiro Garzon, Rosa Lapalombella
https://pubmed.ncbi.nlm.nih.gov/32536290Profile and Management of Toxicity of Selinexor and Belantamab Mafodotin for the Treatment of Triple Class Refractory Multiple Myeloma.
Karun Neupane, Ahsan Wahab, Adeel Masood...
https://pubmed.ncbi.nlm.nih.gov/34234609Treatment of HIV-associated primary CNS lymphoma with antiretroviral therapy, rituximab, and high-dose methotrexate.
Kathryn Lurain, Thomas S Uldrick, Ramya Ramaswami...
https://pubmed.ncbi.nlm.nih.gov/32609814EBV-associated primary CNS lymphoma occurring after immunosuppression is a distinct immunobiological entity.
M K Gandhi, T Hoang, S C Law...
https://pubmed.ncbi.nlm.nih.gov/33202420CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2014-2018.
Quinn T Ostrom, Gino Cioffi, Kristin Waite...
https://pubmed.ncbi.nlm.nih.gov/34608945