Sintilimab Plus R-CHOP as the First-line Treatment in Patients With Diffuse Large B-Cell Lymphoma.
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|ClinicalTrials.gov Identifier: NCT04023916|
Recruitment Status : Unknown
Verified December 2019 by Shi Yuankai, Chinese Academy of Medical Sciences.
Recruitment status was: Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-Cell Lymphoma Sintilimab TP53 Mutation||Drug: Sintilimab-R-CHOP||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Sintilimab Plus R-CHOP as the First-line Treatment for DLBCL Patients With TP53 Mutation and PD-L1 Positive.|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||July 30, 2021|
Participants with previously untreated DLBCL will receive rituximab and CHOP during Cycle 1 (21-day cycle) and Sintilimab, rituximab, and CHOP during Cycles 2-6 (21-day cycle) ,Sintilimab and rituximab during Cycles 6-8 (21-day cycle) , followed by Sintilimab from Cycles 9-14 (8-week cycle) during consolidation treatment.
Sintilimab:200 mg IV on Day 1 Cycles 2-8, during induction treatment, followed by 200 mg IV on Day 1 of Cycles 9-14.
Drug: Rituximab Rituximab:Participants with previously untreated DLBCL will receive rituximab at a dose of 375 mg/m^2 IV on Day 1 of Cycle 1-8, during induction treatment.
Drug: Cyclophosphamide Cyclophosphamide will be administered at a dose of 750 mg/m^2 IV on Day 2 of Cycle 1-6, during induction treatment.
Drug: Doxorubicin Hydrochloride Liposome Injection Doxorubicin Hydrochloride Liposome Injection will be administered at a dose of 35 mg/m^2 IV on Day 2-3 of Cycle 1-6, during induction treatment.
Drug: Vincristine Vincristine will be administered at a dose of 1.4 mg/m^2 (maximum 2 mg) IV on Day 2 of Cycle 1-6, during induction treatment.
Drug: Prednisone Prednisone will be administered at a dose of 40 mg/m^2 orally on Days 1-5 of Cycle 1-6, during induction treatment. Prednisolone may be given if prednisone is unavailable.
- complete remission rate [ Time Frame: every 3 months until 30 months after the last patient's enrollment. ]complete remission rate after treated by Sintilimab+ R-CHOP regimen.
- overall survival [ Time Frame: 30 months after the last patient's enrollment ]from the date of inclusion to date of death, irrespective of cause
- adverse events [ Time Frame: from the date of first cycle of treatment to 30 months after last patient's enrollment ]any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.For safety reasons, the initial enrollment of the first 6 patients in the study will be slow and conduct intensive monitoring for safety. the monitoring time window for each patient is 21 days after the first treatment. If the dose-limited toxicity event was observed in more than 2 of the first 6 patients and was assessed by the research team as caused by cumulative exposure to the study drug combination therapy, the trial will be stopped.
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): NCT04023916
|Contact: Yuankai Shi, M.D||86 email@example.com|
|Contact: Yan Qin, M.D||86 firstname.lastname@example.org|
|Principal Investigator:||Yuankai Shi, M.D||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|