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Relapsed/Refractory Primary Central Nervous System LymphomaPhase 1/2NCT06556199

A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma

A Phase 1/2 study testing Selinexor, Temozolomide and Anti-PD-1 monoclonal antibody in people with Relapsed/Refractory Primary Central Nervous System Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a prospective, single-arm, open label, Phase Ib/II clinical study to evaluate the safety and efficacy of selinexor in combination with temozolomide and anti-PD-1 monoclonal antibody in patients with relapsed/refractory primary central nervous system lymphoma(PCNSL). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Selinexor, Temozolomide and Anti-PD-1 monoclonal antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
31 Aug 2024to 31 Aug 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 18 and 75 (inclusive).
  • Participants must be able to understand and be willing to sign a written informed consent document.
  • Eastern Cooperative Oncology Group performance status 0 to 3.
  • Life expectancy of ≥ 3 months (in the opinion of the investigator).
  • Primary central nervous system lymphoma (PCNSL) of B-cell origin confirmed by pathology (histology or cytology)
  • Measurable disease was defined as at least ≥1.0cm in short-diameter by enhanced MRI.
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  • Recurrent/refractory PCNSL: Must have received at least one systemic treatment with methotrexate-based treatment.
  • Any non-hematological toxicity associated with previous treatment should return to grade 1 or normal (except hair loss according to NCI CTCAE version 5.0)
  • Bone marrow and organ function meet the following criteria (no blood transfusion within 14 days prior to screening, no G-CSF, no medication correction) :
  • Bone marrow function: absolute value of neutrophils ≥1.5×10^9/L, platelets ≥80×10^9/L, hemoglobin ≥80 g/L;
  • Liver function: serum total bilirubin ≤1.5×ULN (≤3.0×ULN, if there is liver metastasis); Glutamic oxalic aminotransferase (AST) and glutamic pyruvic aminotransferase (ALT) ≤2.5×ULN (≤5.0×ULN, if there is liver metastasis);
  • Coagulation function: International standardized ratio (INR) and activated partial thrombin time ≤1.5×ULN;
  • Renal function: serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL/min (male: Cr (ml/min) = (140-age) × body weight (kg) /72× serum creatinine concentration (mg/dl); Female: Cr (ml/min) = (140- age) × body weight (kg) /85× serum creatinine concentration (mg/dl)
  • Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 6 months after the last dose.
  • Can accept multiple MRI/CT and lumbar puncture examination.
  • Swallowing oral tablets/capsules without difficulty.
  • Good compliance, willing to follow the visit schedule, dosing schedule, laboratory examination and other test procedure.

Who cannot join

  • Pathological diagnosis was T cell lymphoma.
  • Anti-tumor therapy with chemotherapy, radiotherapy, immunotherapy or antibody drugs, or Chinese herbal medicine with anti-tumor indications, small-molecule targeted therapy within 2 weeks, monoclonal antibody-coupled drugs or cytotoxin therapy within 10 weeks, and autologous stem cell transplantation within 6 months before the first administration.
  • Participation in another clinical study with an investigational product during the 4 weeks prior to the first day of study treatment.
  • Patients who use systemic adrenal corticosteroids for more than 5 days within 14 days prior to medication or who need to take >10mg of dexamethasone or equivalent drugs daily to control CNS disease.
  • Active concurrent malignancy requiring active therapy.
  • Prior treatment with temozolomide or anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs within 6 months prior to initial administration
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  • Have uncontrolled or significant cardiovascular disease, including (but not limited to) : Any of the following: congestive heart failure (NYHA Class III or IV);myocardial infarction; unstable angina; or the presence of an arrhythmia requiring treatment at the time of screening with a left ventricular ejection fraction (LVEF) < 50% in the 6 months prior to initial dosing; Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, undefined cardiomyopathy); A clinically significant history of prolonged QTc, grade II type II atrioventricular block or grade III atrioventricular block, or QTc interphase (method F) > 470 msec (female) or > 480msec (male);Atrial fibrillation (EHRA grade ≥2b);Patients with unmanageable hypertension were deemed unsuitable for participation in the study.
  • Uncontrolled infections or infections that require intravenous antibiotic treatment.
  • Chronic hepatitis B carriers with active hepatitis B or C infection (hepatitis B: acute hepatitis B, untreated chronic hepatitis B virus infection, HBV-DNA≥ the detection limit of each center; Hepatitis C: HCV RNA positive) or syphilis. Notes: Non-active HBV surface antigen (HBsAg) carriers, subjects with active HBV infection and persistent anti-HBV inhibition (HBV DNA < each center detection limit), and subjects cured of HCV can be enrolled.
  • Human immunodeficiency virus (HIV) infection
  • Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy or gastric banding surgery.
  • Prior allogenic stem cell transplant.
  • For female subjects, they are currently pregnant or breastfeeding.
  • Allergy to the investigational drug or excipient.
  • The patient has active mental illness, alcohol, drug or substance abuse.
  • The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may affect the patient's safety or compliance with the study procedure.
  • There are other conditions that the investigator considers inappropriate to participate in this clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xianggui Yuan contact

+8613989883884

yuanxg@zju.edu.cn

Wenbin Qian contact

+8613605801032

qianwb@zju.edu.cn

China1 site, 1 recruiting

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hanzhou, Zhejiang, 310009

    Wenbin Qian, +8613605801032, qianwb@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Efficiency and Safety of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma: A Prospective, Single-arm, Open, Phase Ib/II Clinical Study

This study is a prospective, single-arm, open label, Phase Ib/II clinical study to evaluate the safety and efficacy of selinexor in combination with temozolomide and anti-PD-1 monoclonal antibody in patients with relapsed/refractory primary central nervous system lymphoma(PCNSL). Phase Ib used a "3+3" dose-climbing design to confirm the safety, maximum-tolerated dose (MTD,if any) and recommended phaseII dose (RP2D) of selinexor in combination with fixed dose of temozolomide and anti-PD-1 monoclonal antibody for 6 cycles. Phase II was a comprehensive evaluation of efficacy and safety. Subjects who achieved complete remission or partial remission were treated with anti-PD-1 monoclonal antibody maintenance therapy until disease progression or recurrence, intolerance of toxicity, death, loss of follow-up, withdrawal of notification (whatever happened first).

Being tested
Selinexor, Temozolomide, Anti-PD-1 monoclonal antibody
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelinexorDrug

    Selinexor dose escalation: 40,60,80mg respectively every week, and dose expansion at the RP2D of Selinexor,every 3 weeks for 6 cycles.

  • TemozolomideDrug

    Temozolomide 150mg/m2 po d1-5 every 3 weeks for 6 cycles.

  • Anti-PD-1 monoclonal antibodyDrug

    The dose of anti-PD-1 monoclonal antibody is fixed dose 200 mg intravenously every 3 weeks until until disease progression or recurrence, intolerance of toxicity, death, loss of follow-up, withdrawal of notification (whatever happened first).

Study groups in NCT06556199
Study groupRoleWhat they receive
selinexor-based treatmentExperimentalNot described
Receives: Drug: Selinexor; Drug: Temozolomide; Drug: Anti-PD-1 monoclonal antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase 2 dose

    To determine the recommended phase 2 dose for Selinexor.

    Measured: Up to 21days

  2. Objective response rate (ORR) for Phase II study

    The objective response rate (ORR) is defined as the proportion of patients with CR or PR at the end of induction treatment.

    Measured: 18 weeks

Secondary outcomes (3)

  1. Progression-free survival (PFS)

    PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

    Measured: Up to 2 years after enrollment

  2. Overall survival (OS)

    OS is defined as the duration of time from start of treatment to time of death.

    Measured: Up to 2 years after enrollment

  3. Duration of response

    The duration of overall response is measured from the time achieving ORR to time of progression, relapse or death, whichever occurs first.

    Measured: Up to 2 years after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2024
  2. Study start31 Aug 2024
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06556199
Sponsor's protocol ID
R202333
Status last verified
Aug 2024
First submitted
7 Aug 2024
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Selinexor, Temozolomide and Anti-PD-1 monoclonal antibody in people with Relapsed/Refractory Primary Central Nervous System Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xianggui Yuan (+8613989883884, yuanxg@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase 2 dose (time frame: Up to 21days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06556199.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

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