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| Name | Class |
|---|---|
| China Food and Drug Administration | OTHER_GOV |
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Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the efficacy and safety of pegylated aspargase(PEG-ASP)combined with etoposide and gemcitabine (PEG) treatment in this population.
Treatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500unit/m2 PEG-ASP at three different sites.The regimen was repeated every 3 weeks.Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got complete remission ,partial regression or stable disease.Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved-field radiation (IFRT) dose was 50-56 Gy.Stage IIIE/IVE patients were given for a maximum of six cycles.Refractory/relapsed patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Autologous haematopoietic stem cell transplantation (AHSCT) was recommended after achieving CR for advanced stage and refractory/relapsed patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG group | Experimental | Treatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500U/m2 Pegaspargase at three different sites.The regimen was repeated every 3 weeks.Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved-field radiation (IFRT) dose was 50-56 Gy.Stage IIIE/IVE patients were given for a maximum of six cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 1000mg/m2, ivd on day 1 and 8 of each 21 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | up to end of follow-up-phase (approximately 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | up to end of follow-up-phase (approximately 3 years) | |
| complete remission rate | every 3 weeks,up to completion of chemotherapy(approximately 3months) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | including hematological safety and non-hematological safety | up to end of follow-up-phase (approximately 3 years) |
Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hua wang, MD. | Contact | 0086-02087342462 | wanghua@sysucc.org.cn | |
| hua wang, MD. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| hua wang, MD. | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Please Select | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39268981 | Derived | Feng D, Yan Z, Fu B, Bai S, Zhu L, Gale RP, Xia Z, Liang Y, Wang H. Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma. Hematology. 2024 Dec;29(1):2402102. doi: 10.1080/16078454.2024.2402102. Epub 2024 Sep 13. |
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| ID | Term |
|---|---|
| D016312 | Treatment Refusal |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| C042705 | pegaspargase |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| etoposide | Drug | 100mg/m2,4h-intravenous infusion on day1-3 of each 21 day cycle. |
|
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| Pegaspargase | Drug | 2500U/m2 im on day 1 of each 21 day cycle. |
|
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| involved-field radiotherapy | Radiation | Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy. |
|
|
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |