Selinexor, Anti-PD-1 Antibody and P-GemOx Regimen in R/R NKTCL

Sponsor
Ruijin Hospital
Study ID
NCT06573151
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Selinexor, anti-PD-1 antibody and P-GemOx — DRUG
    Selinexor, 40mg, qw, po; Pegaspargase, 2500U/m2, IM, d1; Gemcitabine, 1000mg/m2, i.v., d1, d8; Oxaliplatin, 130mg/m2, i.v., d1; anti-PD1 antibody, 200mg, d2, i.v. (21d cycle);

Study Details

A multicenter, prospective trial to evaluate the efficacy and safety of Selinexor, anti-PD-1 antibody and P-GemOx in the treatment of relapsed or refractory Natural Killer / T-cell lymphoma.

Key Dates

Start date
Sep 1, 2024
Status verified
Aug 2024
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

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

Arms

  • Experimental: Chemo
    Patients receive 3 cycles of Selinexor, anti-PD-1 antibody plus P-GemOx.

Primary Outcome Measure

Best CRR [ Time Frame: through study completion, an average of 1 year] ]

Central Contacts

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