Back to resultsClinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
Primary Purpose
nk/T-cell Lymphoma, Newly Diagnosed, Advanced Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
XPO1 inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for nk/T-cell Lymphoma
Eligibility Criteria
Inclusion Criteria: 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; Clinical stage III~IV; Normal major organ function, meeting the following definitions: Hematology: WBC ≥ 3.5 x 10 9/L, PLT ≥ 75 x 10 9/L, Hb ≥ 80 g/L; Liver and kidney function: AST and ALT ≤ 3.0 ULN; TBIL ≤ 2.0 mg/dL; CCr ≥ 60 mL/min; liver and kidney function impairment caused by tumor compression is not limited by this; Fibrinogen: normal at first cycle Expected survival > 6 months Agree to use effective contraception; Understand and voluntarily sign written informed consent Exclusion Criteria: 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; Known history of human immunodeficiency virus (HIV) infection Known hypersensitivity to the study drug or any of its excipients; Presence of other active malignancy requiring treatment that could interfere with this study; Patients with other conditions not suitable for enrollment as judged by the investigator.
Sites / Locations
- ChinaPLAGHRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
COPL + XPO1 inhibitor (Selinexor, 60 mg, po., d1,8,15)
Outcomes
Primary Outcome Measures
response rate
complete remission + partial remission
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Secondary Outcome Measures
the 1-year PFS
To evaluate the 1-year PFS of XCOPL regimen in advanced NK/T-cell lymphoma
the 1-year OS
To evaluate the 1-year OS of XCOPL regimen in advanced NK/T-cell lymphoma
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.
Full Information
NCT ID
NCT05833893
First Posted
February 25, 2023
Last Updated
April 18, 2023
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05833893
Brief Title
Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
Official Title
Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
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.
Detailed Description
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. Initial safety and PET-CT assessment were performed after 3 cycles of treatment (which could be delayed until 4 cycles of treatment in special cases). Patients who achieved partial remission or above will continue the original regimen, and patients who did not achieve partial remission or above will perform re-biopsy and be excluded from the group. Patients who remain partial remission by PET-CT evaluation after 6 cycles may switch to a second-line regimen (referring to NCCN guidelines, GDP regimen combined with selinexor is recommended). Chemotherapy will be performed for up to 8 cycles (followed by autologous or allogeneic hematopoietic stem cell transplantation), after which follow-up period was entered. It is recommended to perform ultrasound or CT evaluation, peripheral blood ctDNA and EBV copy number every three months during the first year of follow-up, and PET-CT evaluation every half a year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
nk/T-cell Lymphoma, Newly Diagnosed, Advanced Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
COPL + XPO1 inhibitor (Selinexor, 60 mg, po., d1,8,15)
Intervention Type
Drug
Intervention Name(s)
XPO1 inhibitor
Other Intervention Name(s)
COPL
Intervention Description
COPL + XPO1 inhibitor (Selinexor, 60 mg, po., d1,8,15)
Primary Outcome Measure Information:
Title
response rate
Description
complete remission + partial remission
Time Frame
1-year
Title
Incidence of Treatment-Emergent Adverse Events
Description
Incidence of Treatment-Emergent Adverse Events
Time Frame
1-year
Secondary Outcome Measure Information:
Title
the 1-year PFS
Description
To evaluate the 1-year PFS of XCOPL regimen in advanced NK/T-cell lymphoma
Time Frame
1-year
Title
the 1-year OS
Description
To evaluate the 1-year OS of XCOPL regimen in advanced NK/T-cell lymphoma
Time Frame
1-year
Title
the ctDNA and EBV copy number in peripheral blood
Description
To evaluate the feasibility of measurable residual disease (MRD) detection and clinical recurrence prediction by ctDNA and EBV copy number.
Time Frame
1-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Clinical stage III~IV;
Normal major organ function, meeting the following definitions: Hematology: WBC ≥ 3.5 x 10 9/L, PLT ≥ 75 x 10 9/L, Hb ≥ 80 g/L; Liver and kidney function: AST and ALT ≤ 3.0 ULN; TBIL ≤ 2.0 mg/dL; CCr ≥ 60 mL/min; liver and kidney function impairment caused by tumor compression is not limited by this; Fibrinogen: normal at first cycle
Expected survival > 6 months
Agree to use effective contraception;
Understand and voluntarily sign written informed consent
Exclusion Criteria:
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;
Known history of human immunodeficiency virus (HIV) infection
Known hypersensitivity to the study drug or any of its excipients;
Presence of other active malignancy requiring treatment that could interfere with this study;
Patients with other conditions not suitable for enrollment as judged by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Zhao, Graduate
Phone
010-66937232
Email
zhaoyu301@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sai Huang, Graduate
Phone
010-66937232
Email
helinahs@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Zhao, Graduate
Organizational Affiliation
Chief
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sai Huang, Graduate
Organizational Affiliation
Attending doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChinaPLAGH
City
Beijing
State/Province
Haidian
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Zhao, Graduate
Phone
010-66937232
First Name & Middle Initial & Last Name & Degree
Sai Huang, Graduate
Phone
010-66937232
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Clinical study of XPO1 inhibitor Selinexor combined with COPL in newly diagnosed advanced NK/T-cell lymphoma
Citations:
PubMed Identifier
32972802
Citation
Benkova K, Mihalyova J, Hajek R, Jelinek T. Selinexor, selective inhibitor of nuclear export: Unselective bullet for blood cancers. Blood Rev. 2021 Mar;46:100758. doi: 10.1016/j.blre.2020.100758. Epub 2020 Sep 15.
Results Reference
result
PubMed Identifier
27347812
Citation
Tse E, Kwong YL. Diagnosis and management of extranodal NK/T cell lymphoma nasal type. Expert Rev Hematol. 2016 Sep;9(9):861-71. doi: 10.1080/17474086.2016.1206465. Epub 2016 Jul 8.
Results Reference
result
PubMed Identifier
28911074
Citation
Lim SH, Hong JY, Lim ST, Hong H, Arnoud J, Zhao W, Yoon DH, Tang T, Cho J, Park S, Ko YH, Kim SJ, Suh C, Lin T, Kim WS. Beyond first-line non-anthracycline-based chemotherapy for extranodal NK/T-cell lymphoma: clinical outcome and current perspectives on salvage therapy for patients after first relapse and progression of disease. Ann Oncol. 2017 Sep 1;28(9):2199-2205. doi: 10.1093/annonc/mdx316.
Results Reference
result
Learn more about this trial
Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
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