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Trial Title:
Clinical Study of XPO1 Inhibitor Selinexor Combined With COPL in Newly Diagnosed Advanced NK/T-cell Lymphoma
NCT ID:
NCT05833893
Condition:
nk/T-cell Lymphoma
Newly Diagnosed
Advanced Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
XPO1 inhibitor
Description:
COPL + XPO1 inhibitor (Selinexor, 60 mg, po., d1,8,15)
Arm group label:
Treatment group
Other name:
COPL
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.
Criteria for 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.
Gender:
All
Minimum age:
14 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ChinaPLAGH
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Zhao, Graduate
Phone:
010-66937232
Contact backup:
Last name:
Sai Huang, Graduate
Phone:
010-66937232
Start date:
May 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05833893
