Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Extra-nodal NK/T Cell Lymphoma
NCT ID: NCT04484506
Last Updated: 2020-07-23
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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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2011-10-20
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stage I/II nasal ENKTL
2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation
pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone
Cyclophosphamide 750 mg/m2 intravenously on day 1, vincristine 1.4 mg/m2 intravenously on day1, etoposide 60mg/m2 intravenously on days 1-3; pegaspargase 2500IU/m2 intramuscularly on day 2, prednisone 100mg orally on days 1-5.
Stage III/IV or primary extra-nasal ENKTL
6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation
pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone
Cyclophosphamide 750 mg/m2 intravenously on day 1, vincristine 1.4 mg/m2 intravenously on day1, etoposide 60mg/m2 intravenously on days 1-3; pegaspargase 2500IU/m2 intramuscularly on day 2, prednisone 100mg orally on days 1-5.
Interventions
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pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone
Cyclophosphamide 750 mg/m2 intravenously on day 1, vincristine 1.4 mg/m2 intravenously on day1, etoposide 60mg/m2 intravenously on days 1-3; pegaspargase 2500IU/m2 intramuscularly on day 2, prednisone 100mg orally on days 1-5.
Eligibility Criteria
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Inclusion Criteria
* age 14-80 years
* no prior chemotherapy or radiotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* at least one measurable lesion
* adequate bone marrow function (i.e. hemoglobin ≥80 g/l, absolute neutrophil count ≥ 1.0 × 10\^9/L, platelets ≥ 100 ×10\^9/L), adequate renal function (i.e. serum creatinine ≤177 μmol/L), adequate hepatic function (e.g. total bilirubin ≤ two times the upper limit of normal, and ALT /AST ≤2.5 times the upper limit of normal)
* expected survival of more than three months
Exclusion Criteria
* pre-existing coagulation disorder
* other concomitant neoplasms
* severe infection
* positive HIV antibody
* HBV DNA titer higher than 10\^4 copies /ml in HBsAg-positive patients post antiviral therapy
* pregnant or lactating women
* women of childbearing age unwilling to take contraceptive measures during the study period
14 Years
80 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Peking University International Hospital
OTHER
Hebei Medical University Fourth Hospital
OTHER
Jiangxi Provincial Cancer Hospital
OTHER
Peking University
OTHER
Responsible Party
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Jun Zhu
Dr.
Locations
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Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COEPL for NKTCL
Identifier Type: -
Identifier Source: org_study_id
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