GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
NCT ID: NCT04917250
Last Updated: 2021-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
15 participants
INTERVENTIONAL
2020-03-20
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment arm
Treated with gemcitabine, pegaspargase, etoposide and dexamethasone
Gemcitabine
1000mg/㎡，d1,4 ivdrip
Pegaspargase
2500IU/㎡, maximum dose less than 3750IU
Etoposide
100mg/㎡，d1-3 ivdrip
Dexamethasone
20mg/d d1-4 ivdrip
Interventions
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Gemcitabine
1000mg/㎡，d1,4 ivdrip
Pegaspargase
2500IU/㎡, maximum dose less than 3750IU
Etoposide
100mg/㎡，d1-3 ivdrip
Dexamethasone
20mg/d d1-4 ivdrip
Eligibility Criteria
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Inclusion Criteria
* refractory or relapsed after initial remission, or stage III-IV de novo patients
* PET/CT or CT/MRI with at least one objectively evaluable lesion.
* 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\>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
* Sign the informed consent form
Exclusion Criteria
Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.
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.
16 Years
75 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Responsible Party
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LIANG WANG
Director of Dept. of Hematology, Beijing Tongren Hospital
Principal Investigators
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Liang Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital
Locations
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Beijing Tongren Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TRhos-ENKTCL-7
Identifier Type: -
Identifier Source: org_study_id
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