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Central Nervous System LymphomaPhase 1/2NCT05698147

Selinexor in Combination With MTX+Ritu to Treat R/R CNSL

A Phase 1/2 study testing Selinexor, Rituximab and Methotrexate in people with Central Nervous System Lymphoma, run by Tong Chen, MD at 5 sites 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
Search all trials

Trial summary

This is a single-arm and open-label study to explore X+MTX+Ritu (ATG-010, Methotrexate, Rituximab) regimen in Relapse refractory PCNSL patients. Approximately 30 patients will be enrolled in the study. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Central Nervous System Lymphoma
What is being tested?
Selinexor, Rituximab and Methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
5 sitesChina
Study dates
3 Aug 2023to 31 Dec 2026
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

  • Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
  • Participants must be able to understand and be willing to sign a written informed consent document.
  • Men and woman who are 18-75 years old on the day of consenting to the study.
  • Histologically documented PCNSL and SCNSL secondary to histologically documented systemic diffuse large B-cell lymphoma (DLBCL).
  • Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL.
  • Patients must have response or remain stable disease for 2 months to prior methotrexate-based regimen.
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  • Patients who had prior autologous hematopoietic stem cell transplantation are eligible.
  • Patients with parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) 28 days prior to cycle1 day 1(C1D1). For patients with leptomeningeal disease only, CSF cytology must document lymphoma cells.
  • Participants must have an Eastern Cooperative Oncology Group performance status of 0-3.
  • Participants must have adequate bone marrow and organ function shown by:
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
  • Platelets ≥ 75 x 10^9/L and no platelet transfusion within the past 14 days prior to study registration c Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cell (RBC) transfusion within the past 14 days prior to study registration
  • International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal.
  • Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome.
  • Calculated creatinine clearance(CrCl)≥50ml/min using the Cockcroft-Gault equation or 24-hour urine collection.
  • Life expectancy of > 3 months.

Who cannot join

  • Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded.
  • Lymphoma patients with only intraocular involvement.
  • Pathological diagnosis of PCNSL is T-cell lymphoma.
  • Patients with disease progression within 6 months of prior methotrexate-containing regimen.
  • patients only had received stereotactic radiation therapy as prior treatment.
  • Patients have received chemotherapy, monoclonal antibodies or targeted anticancer therapy within 21 days or 5 half-lives, whichever is shorter, prior to C1D1.
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  • Patients with active, unstable cardiovascular diseases, fits any of the following:
  • myocardial infarction within 6 months prior to the study enrollment
  • unstable angina within 3 months prior to the study enrollment
  • Uncontrolled clinically-significant conduction abnormalities (e.g., ventricular tachycardia, ventricular fibrillation, etc.)
  • Congestive heart failure (CHF) of New York Heart Association (NYHA) ≥ Grade 3
  • Echocardiography showing left ventricular ejection fraction less than 50%
  • Uncontrolled active infection within 1 week prior to the first dose of study drug.
  • Known active hepatitis B, or C infection or HIV infection; Note: Hepatitis B virus (HBV) surface antigen (HBsAg) and or hepatitis B core antibody-positive but undetectable HBV DNA or Hepatitis C virus (HCV) antibody positive but hepatitis C virus RNA undetectable are allowed.
  • Active GI dysfunction interfering with the ability to swallow tablets, or any GI dysfunction that could interfere with absorption of study treatment.
  • Prior exposure to a selective inhibitor of nuclear export(SINE) compound, including selinexor.
  • Serious, active psychiatric, or medical conditions which, in the opinion of the Investigator, could interfere with study treatment.

Trial locations and contacts

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

Tong Chen, Ph.D contact

+862152887102

chentong@fudan.edu.cn

Yuan Yan, Ph.D contact

+862152888283

yuanyan@fudan.edu.cn

5 sites in 1 country

China5 sites, 5 recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Wenbin Li, Ph.D, +8615301377998, neure55@126.com

    Not yet recruiting

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, Fujian

    Zhiyong Zeng, Ph.D

    Not yet recruiting

  • The First Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui

    Jian Ge, Ph.D

    Not yet recruiting

  • Department of Hematology, Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

    Tong Chen, +862152887102, chentong@fudan.edu.cn

    Yan Yuan, +862152888283, yuanyan@fudan.edu.cn

    Recruiting

  • Oncology Department of The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Mingzhi Zhang, PhD, 13838565629, mingzhi_zhang@126.com

    Mingzhi Zhang, PhD

    Not yet recruiting

Other trials in China

About this study

Official title: Selinexor in Combination With Methotrexate and Rituximab for Relapsed /Refractory Central Nervous System (CNS) Lymphoma

This is a single-arm and open-label study to explore X+MTX+Ritu (ATG-010, Methotrexate, Rituximab) regimen in Relapse refractory PCNSL patients. Approximately 30 patients will be enrolled in the study. In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen and escalating doses of oral ATG-010 weekly in a 3+3 design. Then a phase 2 expansion at the recommended dose level based on phase 1b trial will be conducted to evaluate the efficacy, safety and tolerability.

Read the detailed description

In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen （Methotrexate 3.5 g/m2, d1; Rituximab 375 mg/m2, d0）and escalating doses of oral ATG-010 weekly in a 3+3 design. ATG-010 dose level (DL) 1, 2 and 3 are 60, 80 and 100mg respectively respectively on day 1,8,15,22 for 28-days cycle.

The phase 2 expansion at the recommended dose level based on phase 1b trial. The total 6 cycles, 28 days per cycle . And, Subjects participating in the study will undergo a screening period（up to 21days）, a treatment period, and a follow-up period. The screening period is a maximum of 21 days before treatment period, And will be followed by 6 cycles of combination treatment（28 days per cycle）.

partial remission(PR) patients after induction treatment will continue ATG-010 maintenance up to 1 year or until disease progression, intolerable toxicity, death.

Being tested
Selinexor, Rituximab, Methotrexate
Keywords
Relapse refractory, Selinexor, ATG-010, Primary Central Nervous System Lymphoma（PCNSL）, Secondary Central Nervous System Lymphoma（SCNSL）

What participants receive

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

  • SelinexorDrug

    Also called ATG-010

    Selinexor dose escalation: 60,80,100mg respectively on day 1,8,15,22 for 28 days cycles, and dose expansion at the RP2D of Selinexor.

    PR patients after induction treatment will continue ATG-010 maintenance up to 1 year or until disease progression, intolerable toxicity, death.

  • RituximabDrug

    Also called RiTUXimab Injection

    Rituximab 375 mg/m2 intravenous infusion d1, every 28 days for 6 cycles during combination induction treatment.

  • MethotrexateDrug

    Also called MTX

    high-dose Methotrexate 3.5 g/m2 intravenous infusion d1, every 28 days for 6 cycles during combination induction treatment.

Study groups in NCT05698147
Study groupRoleWhat they receive
X-MTX-RituExperimentalEscalating doses of oral ATG-010 weekly in a 3+3 design. ATG-010 dose level (DL) 1, 2 and 3 are 60, 80 and 100mg respectively respectively on day 1,8,15,22 for 28-days cycle.and the phase 2 expansion at the recommended dose level based on phase 1b trial. And， Methotrexate 3.5 g/m2, d1 and Rituximab 375 mg/m2, d0, 28-days cycle.The total 6 cycles, 28 days per cycle.
Receives: Drug: Selinexor; Drug: Rituximab; Drug: Methotrexate

What is being measured

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

  1. Dose Escalation: Maximum Tolerated Dose (MTD) of Selinexor

    The MTD will be determined by study definition as the highest dose level without significant safety and tolerability concern.

    Measured: Assessed from the date of first dose of study treatment to the first cycle ends (maximum 21days)

  2. Dose Escalation: Recommended Phase 2 Does (RP2D) of Selinexor

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy data collected during the dose escalation portion of the study

    Measured: Assessed from the date of first dose of study treatment to the first cycle ends (maximum 21days)

  3. Objective Response Rate (ORR)

    ORR is defined as the proportion of patients with a best response of Complete remission (CR) or Unconfirmed(CRu), or PR during induction therapy

    Measured: Cycle 1 Day 1 (each cycle consists of maximum 21 days) until a CR, CRu or PR (up to 18 cycles(each cycle is 21 days)).

Secondary outcomes (4)

  1. Duration of Response (DOR)

    Duration from the first observation of at least PR to time of progressive disease(PD), or deaths due to disease progression,whichever occurs first

    Measured: From first dose of study drug administration to end of treatment, up to 18 cycles(each cycle is 21 days)

  2. Overall Survival (OS)

    Occurrence of death regardless of cause

    Measured: up to 12 months

  3. Progression-Free Survival (PFS)

    Duration from start of study treatment to PD or death (regardless of cause), whichever comes first

    Measured: up to 12 months

  4. Number of Participants with Adverse Events

    Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    Measured: From first dose of study drug administration to end of treatment (up to 18 cycles(each cycle is 21 days))

Timeline

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

  1. First posted26 Jan 2023
  2. Study start3 Aug 2023
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05698147
Sponsor's protocol ID
KY2022-881
Status last verified
Sep 2025
First submitted
4 Jan 2023
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
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, Rituximab and Methotrexate in people with Central Nervous System Lymphoma, run by Tong Chen, MD at 5 sites 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 Tong Chen, Ph.D (+862152887102, chentong@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation: Maximum Tolerated Dose (MTD) of Selinexor (time frame: Assessed from the date of first dose of study treatment to the first cycle ends (maximum 21days)). The study lists 3 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 NCT05698147.

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 16 Sep 2025.

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