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出境医 / 临床实验 / Sintilimab, Pegaspargase and Anlotinib for Stage IV Natural Killer /T-cell Lymphoma

Sintilimab, Pegaspargase and Anlotinib for Stage IV Natural Killer /T-cell Lymphoma

Study Description
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.

Condition or disease Intervention/treatment Phase
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type Drug: LEAP regimen Phase 2

Detailed Description:
Stage IV NK/T-cell lymphoma has a poor prognosis, and autologous hematopoietic stem cell transplantation can improve the prognosis of patients who have achieved remission after chemotherapy. The median survival time for patients who were not suitable for transplantation was about 1 year. Asparaginase is the backbone drug for the treatment of NK/T-cell lymphoma. PD-1 antibody is effective for relapsed/refractory NK/T-cell lymphoma. Our previous study found that anlotinib is active in relapsed/refractory NK/T Cell lymphoma. This study is aimed to investigate the efficacy and safety of Sintilimab, a PD-1 antibody approved in China, in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022
Arms and Interventions
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.
 Drug: LEAP regimen
Patients will be given LEAP regimen every 3 weeks for 8 cycles.
Other Names:
  • Pegaspargase
  • Sintilimab
  • Anlotinib
Outcome Measures
Primary Outcome Measures :
  1. Complete response rate [ Time Frame: Week 24 +/-7 days ]
    The complete response rate will be assessed on week 24.


Secondary Outcome Measures :
  1. 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.

  2. Overall response rate [ Time Frame: Week 24 +/-7 days ]
    The overall response rate will be assessed on Week 24

  3. 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.

  4. Overall survival [ Time Frame: 1-year ]
    Overall survival is defiend as the time from entry onto the treatment until death of any reason


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Contacts
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Contact: Rong Tao, MD., PhD +86-21-25077607 hkutao@hotmail.com
Contact: Wen-Hao Zhang, MD., PhD +86-21-25077607 zwh98@foxmail.com

Locations
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China, Shanghai
Xinhua Hospital Recruiting
Shanghai, Shanghai, China, 200092
Contact: Rong Tao, MD    +86-21-25077603    hkutao@hotmail.com   
Principal Investigator: Rong Tao, MD.,PhD         
Sponsors and Collaborators
Rong Tao
Investigators
Layout table for investigator information
Principal Investigator: Rong Tao, MD., PhD Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Tracking Information
First Submitted Date  ICMJE June 30, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date January 28, 2021
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2019) 		Complete response rate [ Time Frame: Week 24 +/-7 days ]
The complete response rate will be assessed on week 24.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2019)
  • 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.
  • Overall response rate [ Time Frame: Week 24 +/-7 days ]
    The overall response rate will be assessed on Week 24
  • 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.
  • Overall survival [ Time Frame: 1-year ]
    Overall survival is defiend as the time from entry onto the treatment until death of any reason
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sintilimab, Pegaspargase and Anlotinib for Stage IV Natural Killer /T-cell Lymphoma
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.
Detailed Description Stage IV NK/T-cell lymphoma has a poor prognosis, and autologous hematopoietic stem cell transplantation can improve the prognosis of patients who have achieved remission after chemotherapy. The median survival time for patients who were not suitable for transplantation was about 1 year. Asparaginase is the backbone drug for the treatment of NK/T-cell lymphoma. PD-1 antibody is effective for relapsed/refractory NK/T-cell lymphoma. Our previous study found that anlotinib is active in relapsed/refractory NK/T Cell lymphoma. This study is aimed to investigate the efficacy and safety of Sintilimab, a PD-1 antibody approved in China, in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Intervention  ICMJE Drug: LEAP regimen
Patients will be given LEAP regimen every 3 weeks for 8 cycles.
Other Names:
  • Pegaspargase
  • Sintilimab
  • Anlotinib
Study Arms  ICMJE 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.
Intervention: Drug: LEAP regimen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2019) 		37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rong Tao, MD., PhD +86-21-25077607 hkutao@hotmail.com
Contact: Wen-Hao Zhang, MD., PhD +86-21-25077607 zwh98@foxmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004572
Other Study ID Numbers  ICMJE XHLSG-NK-1901
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rong Tao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Rong Tao
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rong Tao, MD., PhD Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
PRS Account Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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