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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04337593
Other study ID # TRhos-ENKTCL-4
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2020
Est. completion date December 31, 2022

Study information

Verified date April 2020
Source Beijing Tongren Hospital
Contact Liang Wang, M.D.
Phone +8615001108693
Email wangliangtrhos@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Drug:
Basiliximab
20mg d1,8, repeated every 3 weeks
Pegaspargase
2500IU/?, d1,repeated every 3 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tongren Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary complete response rate 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 overall response rate 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 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 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
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