NCT07523737

Brief Summary

Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive malignancy accounting for over 80% of primary CNS lymphomas, with an annual incidence of 0.4-0.6 per 100,000 people globally and a rising trend in immunocompetent patients. First-line high-dose methotrexate-based chemotherapy causes severe toxicities and nearly 50% of patients relapse within 1-2 years, developing relapsed/refractory (R/R) disease. Treatment options for R/R PCNSL are scarce, with low response rates, median survival of only 3-6 months, and 5-year survival below 5%. The blood-brain barrier and tumor heterogeneity further worsen outcomes. This prospective, multicenter, single-arm phase II study evaluates the efficacy and safety of pomalidomide, PD-1 inhibitor, and selinexor (PPS) in R/R PCNSL, aiming to provide a new effective treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
26mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Aug 2028

Study Start

First participant enrolled

April 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 6, 2026

Last Update Submit

April 10, 2026

Conditions

Primary Central Nervous System Lymphoma (PCNSL)Diffuse Large B Cell Lymphoma (DLBCL)

Keywords

diffuse large b cell lymphomaprimary central nervous system lymphomapomalidomidePD-1 inhibitorXPO1 inhibitorselinexor

Outcome Measures

Primary Outcomes (1)

  • best overall response rate (ORR) as of 6 cycles of PPS

    Overall response rate means sum of complete response rate and partial response rate

    From the day of initiation of PPS treatment to 3 weeks after 6 cycles of PPS treatment (the length of each cycle is 3 weeks)

Secondary Outcomes (4)

  • Best Complete Response rate (CR) as of 6 cycles of PPS

    From the day of initiation of PPS treatment to 3 weeks after 6 cycles of PPS treatment (the length of each cycle is 3 weeks)

  • Progression free survival (PFS)

    From the day of initiation of PPS as of 24 months

  • overall survival (OS)

    From the day of initiation of PPS as of 24 months

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    From the day of initiation of PPS as of 24 months

Study Arms (1)

PPS group

EXPERIMENTAL

All enrolled patients may initiate induction therapy after completing baseline imaging and relevant laboratory examinations: Pomalidomide: 4 mg on days 1-14, every 3 weeks (q3w), for a total of 6 cycles; Selinexor: 60 mg on days 1, 8, and 15, q3w, for a total of 6 cycles; PD-1 monoclonal antibody: tislelizumab 200 mg on day 1, q3w, for a total of 6 cycles. During induction therapy, patients who achieve complete response (CR) may discontinue from the study to receive consolidation therapy with autologous hematopoietic stem cell transplantation (AHSCT) or dose-optimized whole-brain radiotherapy (WBRT), at the investigator's discretion or the patient's choice. For patients not discontinuing for consolidation therapy, maintenance therapy may be administered after 6 cycles of induction therapy: pomalidomide 4 mg every other day (qod) plus selinexor 40-60 mg once weekly (qw), until disease progression or unacceptable toxicity.

Drug: PomalidomideDrug: PD-1 / PD-L1 monoclonal antibodyDrug: XPO1 inhibitor

Interventions

PD-1 / PD-L1 monoclonal antibodyDRUG

tislelizumab 200 mg on day 1, q3w, for a total of 6 cycles

PPS group
PomalidomideDRUG

4 mg on days 1-14, every 3 weeks (q3w), for a total of 6 cycles

PPS group
XPO1 inhibitorDRUG

Selinexor: 60 mg on days 1, 8, and 15, q3w, for a total of 6 cycles

PPS group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL).
  • Disease progression or relapse after prior treatment with high-dose methotrexate and/or BTK inhibitors.
  • Age between 18 and 75 years.
  • ECOG performance status score 0-4.
  • Expected overall survival \> 3 months.
  • No known hypersensitivity to any study drug.
  • White blood cell count ≥ 3×10⁹/L; absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L.
  • Serum creatinine ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mL/min.
  • ALT and AST ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 2× ULN.
  • Signed written informed consent.

You may not qualify if:

  • Presence of another malignant tumor requiring active pharmacological or surgical intervention at present;
  • Female patients who are pregnant or breastfeeding;
  • Patients (male or female) of reproductive potential who are unwilling to use or fail to use effective contraceptive measures;
  • Known hypersensitivity to any study drug or any excipient ingredients of these products;
  • Active infection (determined by the investigator);
  • History of immunodeficiency, including positive HIV status, other acquired or congenital immunodeficiency disorders, or history of organ transplantation;
  • Documented history of neurological or psychiatric disorders, including epilepsy or dementia;
  • Documented history of autoimmune diseases (except Hashimoto's thyroiditis or thyroid dysfunction);
  • Any severe comorbidity that, in the investigator's judgment, would compromise patient safety or interfere with the completion of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

pomalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Liang Wang, M.D.

    Beijing Tongren Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Wang, M.D.

CONTACT

+861058266633wangliangtrhos@126.com

Jia Cong, M.D.

CONTACT

+861058268442congjia21@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Hematology in Beijing Tongren Hospital

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)