NCT04004572

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

June 30, 2019

Last Update Submit

January 27, 2021

Conditions

Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Keywords

Natural killer/T-cell lymphomaSintilimabPegaspargaseAnlotinib

Outcome Measures

Primary Outcomes (1)

  • Complete response rate

    The complete response rate will be assessed on week 24.

    Week 24 +/-7 days

Secondary Outcomes (4)

  • Progression free survival

    1-year

  • Overall response rate

    Week 24 +/-7 days

  • Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Day 1 of each course of chemotherapy and then every 3 months for 1 year

  • Overall survival

    1-year

Study Arms (1)

LEAP Regimen

EXPERIMENTAL

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

Interventions

LEAP regimenDRUG

Patients will be given LEAP regimen every 3 weeks for 8 cycles.

Also known as: Pegaspargase, Sintilimab, Anlotinib
LEAP Regimen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Interventions

pegaspargasesintilimabanlotinib

Study Officials

  • Rong Tao, MD., PhD

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Tao, MD., PhD

CONTACT

+86-21-25077607hkutao@hotmail.com

Wen-Hao Zhang, MD., PhD

CONTACT

+86-21-25077607zwh98@foxmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate director of department of hematology

Study Record Dates

First Submitted

June 30, 2019

First Posted

July 2, 2019

Study Start

July 1, 2019

Primary Completion

December 30, 2021

Study Completion

December 30, 2022

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)