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Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma

Conditionsnk/T-cell LymphomaNewly DiagnosedAdvanced Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorChinese PLA General Hospital

About this trial

Patients with newly diagnosed, pathologically confirmed NK/T-cell lymphoma of stage III-IV treated with XCOPL regimen. 3 weeks for a cycle, with a total of 6-8 cycles.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥14 years, male or female;

Pathologically confirmed newly diagnosed NK/T cell lymphoma according to WHO classification criteria 2016;

At least one measurable lesion, defined as bidimensionally measurable, intranodal lesion > 1.5 cm in short axis and extranodal lesion > 1.0 cm in short axis;

ECOG score 0~2;

Disqualifiers

Prior allogeneic HCT (allo-HCT)

Active autoimmune disease

Primary central nervous system lymphoma;

Patients with infection which requiring treatment. Could be re-enrollment after infection control;

Trial design

Design model

Single group

Treatments tested in this trial

  • XPO1 inhibitor

    Drug

    COPL + XPO1 inhibitor (Selinexor, 60 mg, po., d1,8,15)

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

response rate

complete remission + partial remission

Time frame
1-year
2

Incidence of Treatment-Emergent Adverse Events

Incidence of Treatment-Emergent Adverse Events

Time frame
1-year

Secondary outcomes

1

the 1-year PFS

To evaluate the 1-year PFS of XCOPL regimen in advanced NK/T-cell lymphoma

Time frame
1-year
2

the 1-year OS

To evaluate the 1-year OS of XCOPL regimen in advanced NK/T-cell lymphoma

Time frame
1-year
3

the ctDNA and EBV copy number in peripheral blood

To evaluate the feasibility of measurable residual disease (MRD) detection and clinical recurrence prediction by ctDNA and EBV copy number.

Time frame
1-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese PLA General Hospital

Lead sponsor

Source ClinicalTrials.gov
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