Trial Title:
The Efficacy and Safety of Chidamide, Anti-PD-1 Antibody in Combination With Pegaspargase Versus DDGP in the Treatment of Newly Diagnosed, Stage III to IV Extranodal Natural Killer/T-Cell Lymphoma
NCT ID:
NCT06255795
Condition:
Extranodal Natural Killer T Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Pegaspargase
Antibodies
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
chidamide, anti-PD1 antibody, and pegaspargase
Description:
6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, anti-PD1 antibody 200mg
intravenously on day 2, chidamide 30mg biw orally, every 21 days.
Arm group label:
chidamide, anti-PD1 antibody, and pegaspargase group
Intervention type:
Drug
Intervention name:
DDGP
Description:
6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, cisplatin 20mg/m2
intravenously on days 1 through 4, dexamethasone 15mg/m2 intravenously on days 1 through
5, gemcitabine 800mg/m2 on day 1 and day 8, every 21 days.
Arm group label:
DDGP
Summary:
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the
efficacy and safety of chidamide, anti-PD1 antibody, and pegaspargase versus
dexamethasone, cisplatin, gemcitabine, and pegaspargase (DDGP) in the treatment of newly
diagnosed, stage III to IV extranodal natural killer/T-cell lymphoma.
Detailed description:
This study will evaluate the efficacy and safety of chidamide, anti-PD1 antibody, and
pegaspargase versus DDGP in the treatment of newly diagnosed, stage III to IV extranodal
natural killer/T-cell lymphoma. Subjects will be randomly assigned 1:1 to chidamide,
anti-PD1 antibody, and pegaspargase or DDGP regimen.
Patients in chidamide, anti-PD1 antibody, and pegaspargase group will receive 6 cycles of
pegaspargase 2500IU/m2 intramuscularly on day1, anti-PD1 antibody 200mg intravenously on
day 2, chidamide 30mg biw orally, every 21 days. Patients in DDGP group will receive 6
cycles of pegaspargase 2500IU/m2 intramuscularly on day1, cisplatin 20mg/m2 intravenously
on days 1 through 4, dexamethasone 15mg/m2 intravenously on days 1 through 5, gemcitabine
800mg/m2 on day 1 and day 8, every 21 days.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Confirmed histological diagnosis of NKTCL
- No previous anti-lymphoma treatment
- Age 14-70 years
- Ann Arbor stage III-IV
- At least one measurable/evaluable site after diagnostic biopsy before treatment
start
- ECOG performance status of 0-2
- Adequate hematological and organ function; i.e. ANC >1000 cells /mmc, platelet
counts > 50.000/mmc, Hemoglobin > 8 g/dl AST, ALT > 1.5 x ULN; serum
bilirubin > 2x ULN (patient with Gilbert disease can be enrolled), Serum
creatinine > 2 x ULN or creatinine clearance > 50ml/min
- Tumor tissue (fresh preferred, achievable tissue is also acceptable)
- 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.
- For men agreement to remain abstinent or to use barrier contraception
- Signed Informed consent
Exclusion Criteria:
- Confirmed histological diagnosis of aggressive NK cell leukemia
- Early stage disease (AA stage I-II)
- Evidence of suspect of CNS disease.
- 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 myasthenia gravis, myositis,
autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,
inflammatory bowel disease, vascular thrombosis associate with antiphospholipid
syndrome, wegener's granulomatosis, Sjogren syndrome, guillan barreè 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.
- 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.
- Active infection requiring systemic therapy
- History of (non-infectious) pneumonitis that required steroids; evidence of
interstitial lung disease or active, non-infectious pneumonitis
- Significant cardiovascular disease, myocardial infarction in the previous 3 months,
unstable arrhythmias, or unstable angina.
- 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).
- HBsAg, HCV or HIV positivity. Positive serology is admitted for HBV and HCV but
DNA/RNA test must be negative
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- Pregnant or lactating women
- 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.
- Other uncontrollable medical condition that may that may interfere the participation
of the study
Gender:
All
Minimum age:
14 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital
Address:
City:
Shanghai
Zip:
200025
Country:
China
Contact:
Last name:
Weili ZHAO
Phone:
+862164370045
Phone ext:
610707
Email:
zhao.weili@yahoo.com
Investigator:
Last name:
Weili ZHAO
Email:
Principal Investigator
Investigator:
Last name:
Shu CHENG
Email:
Principal Investigator
Investigator:
Last name:
Jie XIONG
Email:
Sub-Investigator
Start date:
February 15, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06255795
