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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT06556199
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Relapsed/Refractory Primary Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor dose escalation: 40,60,80mg respectively every week, and dose expansion at the RP2D of Selinexor,every 3 weeks for 6 cycles.
  • Temozolomide — DRUG
    Temozolomide 150mg/m2 po d1-5 every 3 weeks for 6 cycles.
  • Anti-PD-1 monoclonal antibody — DRUG
    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 Details

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).

Key Dates

Start date
Aug 31, 2024
Status verified
Aug 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: selinexor-based treatment

Primary Outcome Measure

Recommended phase 2 dose [ Time Frame: Up to 21days ]

Central Contacts

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