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Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

Primary Purpose

Extranodal NK/T-cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Basiliximab

Pegaspargase

About this trial

This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma focused on measuring extranodal NK/T-cell lymphoma, basiliximab, pegaspargase, CD25

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks

Outcomes

Primary Outcome Measures

complete response rate

evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma

Secondary Outcome Measures

overall response rate

evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma

one year progression free survival rate

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

Full Information

NCT ID

NCT04337593

First Posted

April 4, 2020

Last Updated

April 6, 2020

Sponsor

Beijing Tongren Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04337593

Brief Title

Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2020 (Anticipated)

Primary Completion Date

May 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Extranodal NK/T-cell Lymphoma

Keywords

extranodal NK/T-cell lymphoma, basiliximab, pegaspargase, CD25

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

all patients enrolled will received basiliximab and pegaspargase.

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment arm

Arm Type

Experimental

Arm Description

2500 IU/m2 pegaspargase given on day 1, 20 mg basiliximab given on day 1 and 8, repeated every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Basiliximab

Other Intervention Name(s)

anti-CD25 antibody

Intervention Description

20mg d1,8, repeated every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Pegaspargase

Intervention Description

2500IU/㎡, d1,repeated every 3 weeks

Primary Outcome Measure Information:

Title

complete response rate

Description

evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma

Time Frame

up to 15 weeks±1 week from start of treatment

Secondary Outcome Measure Information:

Title

overall response rate

Description

evaluated by PET-CT scan or MRI, according to 2014 Lugano criteria for lymphoma

Time Frame

up to 15 weeks±1 week from start of treatment

Title

one year progression free survival rate

Description

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

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liang Wang, M.D.

Phone

+8615001108693

wangliangtrhos@126.com

12. IPD Sharing Statement

Learn more about this trial

Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

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