PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Peripheral T-cell Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04040491|
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Newly Diagnosed Peripheral T-cell Lymphoma||Drug: PD-1 blocking antibody, chidamide, lenalidomide and etoposide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Peripheral T-cell Lymphoma|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||April 1, 2022|
Experimental: PD-1 Antibody, chidamide, lenalidomide and etoposide
PD-1 Antibody: 240mg, d1, Chidamide: 20mg, twice a week, Lenalidomide: 25mg, d1-14 Etoposide:100mg/m2, d1-3 and 21 days made one treatment cycle.
Drug: PD-1 blocking antibody, chidamide, lenalidomide and etoposide
PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA.
- Overall Response Rate [ Time Frame: From date of randomization until the date tumor volume has reduced, assessed up to 36 months ]The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation.
- Progression-free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
- Overall Survival [ Time Frame: From date of randomization until date of death from any cause, assessed up to 36 months ]Time from randomization to death for any reason
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040491
|Contact: Mingzhi D Zhang||+8613838565629 ext +8613838565629||Mingzhi_zhang@126.com|
|Oncology Department of The First Affilliated Hospital of Zhengzhou University||Recruiting|
|Zhengzhou, Henan, China, 450052|
|Contact: Mingzhi Zhang, Pro,Dr +8613838565629 Mingzhi_zhang@126.com|
|Contact: Mingzhi Zhang, Zhang +8613838565629 Mingzhi_zhang@126.com|