Sintilimab Plus R-CHOP as the First-line Treatment in Patients With Diffuse Large B-Cell Lymphoma.

NCT04023916 | Unknown Phase 2

• 1 other identifier: NCC2066
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diffuse Large B-Cell Lymphoma; Sintilimab; TP53 Mutation

Keywords

DLBCL; Sintilimab; R-CHOP; TP53; PD-L1

Outcome Measures

Primary Outcomes (1)

• complete remission rate

  complete remission rate after treated by Sintilimab+ R-CHOP regimen.

  every 3 months until 30 months after the last patient's enrollment.

Secondary Outcomes (2)

• overall survival

  30 months after the last patient's enrollment

• adverse events

  from the date of first cycle of treatment to 30 months after last patient's enrollment

Study Arms (1)

Sintilimab-R-CHOP

EXPERIMENTAL

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

Interventions

Sintilimab-R-CHOP DRUG

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.

Sintilimab-R-CHOP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of autologous stem cell transplantation,radiotherapy or chemotherapy.
• History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
• With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
• Lymphoma originated in the central nervous system;
• Left ventricular ejection fraction ≦50％;
• 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;
• Other uncontrolled medical conditions which the investigators think might influence the results of the trial;
• Patients with mental illnesses or other diseases that might not comply with the trial plan;
• Women during pregnancy or lactation;
• HIV positive patients;
• 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;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuankai Shi, M.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuankai Shi, M.D

CONTACT

86 010-87788293; syuankaipumc@126.com

Yan Qin, M.D

CONTACT

86 010-87788293; 13601282738@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: December 1, 2019
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2021
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share