Trials Sponsors Conditions Drugs Pricing

Conditions

DLBCL Primary Extranodal Lymphoma

Keywords

primary extranodal lymphomaDLBCLR-CHOPPD-1camrelizumab

Outcome Measures

Primary Outcomes (1)

complete response rate
24 weeks

Secondary Outcomes (6)

Objective remission rate
six weeks
Objective remission rate
24 weeks
Duration of Response
2 years
Progression-free Survival
2 years
Overall Survival
2 years
+1 more secondary outcomes

Study Arms (1)

camrelizumab+R-CHOP

EXPERIMENTAL

Induction therapy: camrelizumab in combination with rituximab Immunochemotherapy: rituximab, cyclophosphamide, hydroxyldaunorubicin, vincristine, prednisone Maintenance therapy: camrelizumab in patients achieved CR after immunotherapy

Drug: Camrelizumab

Interventions

CamrelizumabDrug

Induction therapy: Camrelizumab 200mg, ivd, D1, Rituximab 375mg/m2, ivd, D1 every 3 weeks up to 2 cycles Immunochemotherapy: Rituximab: 375mg/m2, ivd, D1; Cyclophosphamide: 750mg/m2, iv or ivd, D1; Hydroxyldaunorubicin: 50mg/m2, iv or ivd, D1; Vincristine: 1.4 mg/m2 , iv(max：2mg), D1; Prednisone: 60mg/m2, po, d1-5 every 3 weeks up to 6 cycles Maintenance therapy: Camrelizumab 200mg, ivd, D1 every 4 weeks up to 6 cycles

Also known as: Rituximab, Cyclophosphamide, Hydroxyldaunorubicin, Vincristine, Prednisone

camrelizumab+R-CHOP

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female patients: 18-65 years old.
Newly diagnosed patients

Sponsors & Collaborators

Jiangsu HengRui Medicine Co., Ltd.
Industrycollaborator
Sun Yat-sen University
Otherlead

MeSH Terms

Interventions

camrelizumabRituximabCyclophosphamideDoxorubicinVincristinePrednisone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum Globulins

Study Officials

Huiqiang Huang, professor
Sun Yat-sen University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiqiang Huang, professor

CONTACT

0086-13808885154 huang_sysu@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: Professor

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 26, 2021

Study Start

June 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 2023

You may not qualify if:

\- • Primary DLBCL arise in lymph nodes or other lymphatic tissues.
Primary central nervous system lymphoma or secondary central nervous system involvement, known primary mediastinal lymphoma.
A history of severe allergies or allergic reactions to humanized or murine monoclonal antibodies.
In the past five years, patients with other malignant tumors have undergone radical treatment, except for basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of breast and carcinoma in situ of cervix. History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known
Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than 2500 copies/mL or 1000 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. In addition to active hepatitis B or hepatitis C infections requiring treatment, group trials can be conducted. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 2500 copies/mL or 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group.
Patients with any active infections requiring systemic anti-infective treatment within 14 days of treatment.
Received systemic antineoplastic therapy within 28 days before treatment, including chemotherapy, immunotherapy, biotherapy (cancer vaccine, cytokines, or growth factors that control cancer), etc..
Received major surgery within 28 days before treatment or radiotherapy within 90 days before treatment.
Received live vaccination (except influenza attenuated vaccine) within 28 days before treatment.
Patients requiring long-term systemic glucocorticoid therapy or other immunosuppressive therapy (\>prednisone 10mg/qd or equivalent dose of other glucocorticoid therapy). Allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy.
Patients suffering from uncontrollable comorbid diseases, including but not limited to symptomatic congestive heart failure, uncontrollable hypertension, unstable angina, active peptic ulcer or bleeding disorders.
Pregnant or lactating women.
Patients with a history of interstitial lung disease or non-infectious pneumonia. Subjects who have previously had drug-induced or radioactive non-infectious pneumonia but asymptomatic are allowed to enroll.
Any life-threatening disease, physical condition or organ dysfunction according to the researchers' judgment may endanger the safety of the subject or put the clinical research at excessive risk.

Camrelizumab Plus R-CHOP Regimen in Untreated Primary Extranodal DLBCL

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

camrelizumab+R-CHOP

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

camrelizumab+R-CHOP

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record