- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04004572
Sintilimab, Pegaspargase and Anlotinib for Stage IV Natural Killer /T-cell Lymphoma
A Multi-center, Prospective Study of the Efficacy and Safety of PD-1 Antibody (Sintilimab) in Combination With Pegaspargase and Erlotinib in the Treatment of Stage IV Extranodal NK/T-cell Lymphoma Unfit for High-intensity Chemotherapy
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Rong Tao, MD., PhD
- Phone Number: +86-21-25077607
- Email: hkutao@hotmail.com
Study Contact Backup
- Name: Wen-Hao Zhang, MD., PhD
- Phone Number: +86-21-25077607
- Email: zwh98@foxmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200092
- Recruiting
- Xinhua Hospital
-
Contact:
- Rong Tao, MD
- Phone Number: +86-21-25077603
- Email: hkutao@hotmail.com
-
Principal Investigator:
- Rong Tao, MD.,PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria.
- Stage IV disease according Lugano 2014 staging system. Newly diagnosed patients, or relapsed disease without a history of asparaginase-containing regimen.
- PET/CT or CT/MRI with at least one objectively evaluable lesion.
- The age is greater than 65 years old. Those who are younger than 65 years should have a documented history unfit for high-dose combination chemotherapy (ie. high doses of methotrexate or high doses of dexamethasone, or autologous hematopoietic stem cell transplantation).
- General status ECOG score 0-3 points.
- The laboratory test within 1 week before enrollment meets the following conditions:
Blood routine: Hb>80g/L, PLT>50×109/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Coagulation : plasma fibrinogen ≥ 1.0g / L. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
- Sign the informed consent form.
- Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.
Exclusion Criteria:
- Patients with a history of pancreatitis.
- Active infection requires ICU treatment.
- Concomitant HCV or HIV infection. Patients who are infected with HBV at the same time are not excluded.
- Serious complications such as fulminant DIC.
- Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months.
- Pregnant and lactating women.
- Had a history of autoimmune diseases, and disease was active in the last 6 months, and was still taking oral immunosuppression in the past three months.
For the treatment, the daily dose of oral prednisone is greater than 10 mg.
- Those who were known to be allergic to drugs in the study regimen.
- Patients with other tumors who require surgery or chemotherapy within 6 months.
- Other experimental drugs are being used.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LEAP Regimen
Pegaspargase, 2500IU/m2, im, day 1 Sintilimab, 200mg, iv day1 Anlotinib, 8mg, oral, day 1-14 The LEAP regimen will be repeated every 3 weeks.
|
Patients will be given LEAP regimen every 3 weeks for 8 cycles.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response rate
Time Frame: Week 24 +/-7 days
|
The complete response rate will be assessed on week 24.
|
Week 24 +/-7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: 1-year
|
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
|
1-year
|
Overall response rate
Time Frame: Week 24 +/-7 days
|
The overall response rate will be assessed on Week 24
|
Week 24 +/-7 days
|
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: Day 1 of each course of chemotherapy and then every 3 months for 1 year
|
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
|
Day 1 of each course of chemotherapy and then every 3 months for 1 year
|
Overall survival
Time Frame: 1-year
|
Overall survival is defiend as the time from entry onto the treatment until death of any reason
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1-year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rong Tao, MD., PhD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XHLSG-NK-1901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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