- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04337593
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
Conditions
Intervention / Treatment
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
- Name: Liang Wang, M.D.
- Phone Number: +8615001108693
- Email: wangliangtrhos@126.com
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:
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Lymphoma, Extranodal NK-T-Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Basiliximab
- Pegaspargase
Other Study ID Numbers
- TRhos-ENKTCL-4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Extranodal NK/T-cell Lymphoma
-
The First Affiliated Hospital with Nanjing Medical...Not yet recruiting
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.TerminatedExtranodal NK/T-cell Lymphoma, Nasal TypeChina
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Samsung Medical CenterCompletedExtranodal NK/T Cell LymphomaKorea, Republic of
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