Treatment of Peripheral T-cell Lymphoma
A Randomized Controlled Multi-center Clinical Trial on Treatment of Peripheral T-cell Lymphoma With DGPT Regiment (Gemcitabine,Cisplatin,Prednisone ,Thalidomide )
The purpose of this study is to evaluate the efficacy and safety of GDPT regiment (gemcitabine,cisplatin,Prednisone ,Thalidomide
) for patients with Peripheral T-cell lymphoma.
調査の概要
詳細な説明
Patients with Peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment GDPT regiment (gemcitabine,cisplatin,Prednisone ,Thalidomide
) in the patients with Peripheral T-cell lymphoma.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Henan
-
Zhengzhou、Henan、中国、450052
- Oncology Department of The First Affiliated Hospital of Zhengzhou University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months Histological confirmed Peripheral T cell lymphoma None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups ) At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative Patients could be followed up None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
volunteers who signed informed consent.
Exclusion Criteria:
Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of CNS metastasis History of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigato
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:CHOPレジメン
CHOP(シクロホスファミド、ビンクリスチン、ドキソルビシン、プレドニゾン)レジメン
|
CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt,
d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o,
d1-5.
|
|
実験的:GDPT regimen
GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen
|
GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt(intravenously guttae),d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM)
800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued
use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required.
Efficacy was evaluated every two cycles.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Progression-free Survival
時間枠:up to end of follow-up-phase (approximately 24 months)
|
up to end of follow-up-phase (approximately 24 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Response Rate
時間枠:every 6 weeks,up to completion of treatment(approximately 18 weeks )
|
21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles
|
every 6 weeks,up to completion of treatment(approximately 18 weeks )
|
|
Overall Survival
時間枠:up to the date of death (approximately 5 years)
|
up to the date of death (approximately 5 years)
|
|
|
Median Survival Time
時間枠:24 months
|
24 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Mingzhi Zhang, Pro,Dr、The First Affiliated Hospital of Zhengzhou University
出版物と役立つリンク
一般刊行物
- Sun Y, Li L, Li X, Zhang L, Wang X, Fu X, Sun Z, Zhang X, Li Z, Wu J, Yu H, Chang Y, Yan J, Wu X, Zhou Z, Nan F, Tian L, Zhang M. Outcomes of GDPT (gemcitabine, cisplatin, prednisone, thalidomide) versus CHOP in newly diagnosed peripheral T-cell lymphoma patients. Ther Adv Med Oncol. 2020 May 27;12:1758835920923829. doi: 10.1177/1758835920923829. eCollection 2020.
- Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. doi: 10.1111/bjh.14763. Epub 2017 Jun 9.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- hnslblzlzx2011-3
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