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Sintilimab Plus R-CHOP as the First-line Treatment in Patients With Diffuse Large B-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. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Shi Yuankai, Chinese Academy of Medical Sciences

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Sintilimab and R-CHOP regimen as the first-line treatment for DLBCL patients with TP53 mutation and PD-L1 positive.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Sintilimab TP53 Mutation Drug: Sintilimab-R-CHOP Phase 2

Detailed Description:
This Phase II, open-label, single-center, non-randomized study will evaluate the safety and efficacy of induction treatment consisting of Sintilimab in combination with Rituximab plus chemotherapy (R-CHOP) as the first-line treatment in participants with DLBCL, followed by consolidation treatment with Sintilimab alone in patients who achieve CR at the end of induction.For safety reasons, the initial enrollment of the first 6 patients in the study will be slow and conduct intensive monitoring for safety. If the dose-limited toxicity event was observed in more than 2 of the first 6 patients and was assessed caused by cumulative exposure to the study drug combination therapy, the trial will be stopped.This study also aim to evaluate the correlation of clinical efficacy to the expression of PD-L1,PD-1,CD3,CD4,CD8,CD56,CD58,β2-MG,HLA-DR/DP/DQ and so on by immunohistochemical techniques.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Sintilimab-R-CHOP
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.
Drug: Sintilimab-R-CHOP

Drug:Sintilimab:

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 30 months after the last patient's enrollment ]
    from the date of inclusion to date of death, irrespective of cause

  2. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results;
  2. Age between 18 to 70 years old;
  3. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
  4. No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment;
  5. Life expectancy no less than 6 months;
  6. The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures;
  7. Ann Arbor stage I~ IV
  8. previously untreated advanced DLBCL.
  9. At least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters in its largest dimension by CT scan or magnetic resonance imaging)
  10. Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of DLBCL.
  11. Agree to remain abstinent or use contraceptive measures.

Exclusion Criteria:

  1. History of autologous stem cell transplantation,radiotherapy or chemotherapy.
  2. History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
  3. With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
  4. Lymphoma originated in the central nervous system;
  5. Left ventricular ejection fraction ≦50%;
  6. Abnormal lab results in enrollment:Neutrophil count: <1.5*10^9/L;Platelet count <75*10^9/L;AST or ALT >2 times the upper limit of normal level,AKP and total bilirubin >1.5 times the upper limit of normal level;serum creatinine >1.5 times the upper limit of normal level;
  7. Other uncontrolled medical conditions which the investigators think might influence the results of the trial;
  8. Patients with mental illnesses or other diseases that might not comply with the trial plan;
  9. Women during pregnancy or lactation;
  10. HIV positive patients;
  11. HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;

Information from the National Library of Medicine

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


Contacts
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Contact: Yuankai Shi, M.D 86 010-87788293 syuankaipumc@126.com
Contact: Yan Qin, M.D 86 010-87788293 13601282738@163.com

Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Yuankai Shi, M.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Shi Yuankai, vice president, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04023916    
Other Study ID Numbers: NCC2066
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shi Yuankai, Chinese Academy of Medical Sciences:
DLBCL
Sintilimab
R-CHOP
TP53
PD-L1
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin