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

NCT ID: NCT06573151

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2027-07-01

Brief Summary

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.

Detailed Description

This study aims to evaluate the efficacy and safety of Selinexor, anti-PD-1 antibody plus P-GemOx in relapsed or refractory NKTCL and find the optimal treatment regimen for patients with relapsed refractory NKTCL.

Patients receive 3 cycles of Selinexor, anti-PD-1 antibody plus P-GemOx, and then PET evaluation.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemo

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

Group Type: EXPERIMENTAL

Selinexor, anti-PD-1 antibody and P-GemOx

Intervention Type: 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);

Interventions

Selinexor, anti-PD-1 antibody and P-GemOx

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);

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Confirmed histological diagnosis of NKTCL nasal type

2. The subject had received prior adequate anti-lymphoma therapy containing asparaginase

3. Age 14-75 years old

4. Expected to live longer than 3 months

5. At least one measurable/evaluable site after diagnostic biopsy before treatment start

6. ECOG performance status of 0-2

7. Adequate hematological and organ function; i.e. ANC >1000 cells /mmc, platelet counts > 50.000/mmc, Hemoglobin > 9 g/dl AST, ALT <3 x ULN; serum bilirubin < 1.5x ULN (patient with Gilbert disease can be enrolled) Serum creatinine < 2 x ULN or creatinine clearance > 50ml/min

8. Tumor tissue (fresh preferred, archival tissue is also acceptable)

9. For women of childbearing potential a negative pregnancy test on day 1 of cycle 1 and agree to adopt adequate measure to avoid pregnancy during study treatment and for at least one year from EOT.

10. For men agreement to remain abstinent or to use barrier contraception

11. Signed Informed consent

Exclusion Criteria

1. Confirmed histological diagnosis of aggressive NK cell leukemia

2. Evidence of suspect of CNS disease.

3. Has an active autoimmune disease that has required systemic treatment in past 2-years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs), including but not limited to myotonia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associate with antiphospholipid syndrome, wegener's granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis. The following exception are allowed: patients with autoimmune related hypothyroidism or type I diabetes mellitus who are on stable treatment. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.

4. Treatment with systemic immunosuppressive medications, including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and anti tumor necrosis factor (anti-TNF) agents within 2 weeks prior to cycle 1 day 1; inhaled corticosteroids are allowed.

5. Active infection requiring systemic therapy

6. History of (non-infectious) pneumonitis that required steroids; evidence of interstitial lung disease or active, non-infectious pneumonitis

7. Significant cardiovascular disease, myocardial infarction in the previous 3 months, unstable arrhythmias, or unstable angina.

8. History of other(s) infiltrating cancer(s) in the previous 3 years that were not treated with curative intent or who are still receiving anticancer therapy (including hormone therapy for breast or prostate cancer).

9. HBsAg, HCV or HIV positivity. Positive serology is admitted for HBV and HCV but DNA/RNA test must be negative

10. Pregnant or lactating women

11. Administration of a live attenuated vaccine within 4 weeks before cyle 1 day 1. Patients must not receive live, attenuate vaccines, including influenza vaccines at any time during study.

12. Other uncontrollable medical condition that may interfere the participation of the study

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Weili Zhao, Prof.

Role: CONTACT

zwl_trial@163.com

008602164370045

Other Identifiers

RJ-NKTCL-5

Identifier Type: -

Identifier Source: org_study_id