Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

April 6, 2020 updated by: LIANG WANG, Beijing Tongren Hospital

Combination of Basiliximab and Pegaspargase in the Treatment of Relapsed/Refractory Extranodal NK/T-cell Lymphoma, Nasal Type: a Single Arm, Open Label, Phase 2 Trial

The purpose of this study is to evaluate the efficacy and safety of Basiliximab in combination with pegaspargase in the treatment of relapsed/refractory NK/T-cell lymphoma.

Study Overview

Status

Not yet recruiting

Detailed Description

The investigators previously found that CD25 was elevated in patients who were resistant to chemotherapy, and CD25 can mediate resistance, which can be reversed by targeting CD25 therapy. Thus, the purpose of this study is to evaluate the efficacy and safety of Basiliximab in combination with pegaspargase in the treatment of relapsed/refractory NK/T-cell lymphoma.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathology confirmed diagnosis of NK/T-cell lymphoma.
  • Previously treated with pegaspargase-based regimens.
  • PET-CT or MRI scan with at least one measurable lesion.
  • ECOG score of 0-3 points.
  • The lab tests within 1 week before enrollment meets the following:

    • Blood routine: Hb≥80g/L, PLT≥50×10e9/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 is normal
  • Sign the informed consent form.
  • Voluntary compliance with research protocols.

Exclusion Criteria:

  • Patients with a history of pancreatitis.
  • Active infection requires ICU treatment.
  • Concomitant HIV infection or active infection with HBV, HCV.
  • Serious complications such as fulminant DIC.
  • Significant organ dysfunction:

    • respiratory failure
    • NYHA classification≥2 chronic congestive heart failure
    • decompensation Hepatic or renal insufficiency
    • high blood pressure and diabetes that cannot be controlled
    • cerebral vascular events within the past 6 months.
  • Pregnant and lactating women.
  • Had a history of autoimmune diseases, and disease was active now. Those who were known to be allergic to drugs in the study regimen.
  • Patients with other tumors who require treatments within 6 months.
  • Other experimental drugs are being used.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: treatment arm
2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks
20mg d1,8, repeated every 3 weeks
Other Names:
  • anti-CD25 antibody
2500IU/㎡, d1,repeated every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete response rate
Time Frame: up to 15 weeks±1 week from start of treatment
evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma
up to 15 weeks±1 week from start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: up to 15 weeks±1 week from start of treatment
evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma
up to 15 weeks±1 week from start of treatment
one year progression free survival rate
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Progression free survival was caculated from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

May 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 4, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

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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