Clinical trial NCT02772822: A Study Comparing the Efficiency and Safety of S-CHOP(Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone) Versus R-CHOP in Untreated CD20(Cluster of Differentiation Antigen 20)-Positive DLBCL Patients
Official title: A Phase Ⅲ, Multi-center, Randomized, Controlled Study to Compare the Efficiency and Safety of SCT400(Recombinant Chimeric Anti-CD20 Monoclonal Antibody, Experimental Drug) Plus CHOP Versus Rituximab Plus CHOP in Untreated CD20-positive DLBCL Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Sinocelltech Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-16
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the efficiency of SCT400 plus CHOP versus Rituximab plus CHOP in untreated CD20-positive DLBCL Patients.

The secondary objective of the study is to evaluate the safety of SCT400 plus CHOP, as well as the presence of human anti-chimeric antibodies (HACA).


Eligibility criteria: Inclusion Criteria:

1. Untreated CD20-positive DLBCL confirmed by local histopathology.
2. International Prognostic Index (IPI) score of 0 to 2:

   Score 0 needs to accompanied by bulky disease, which is defined as the presence of a tumor mass with a diameter of more than 7.5 cm.
3. 18 years to 70 years; Male or female patients.
4. More than 6 months life expectancy.
5. At least one measurable lymph node:

   For nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; For extranodal tumor mass, more than 1.0 cm in the long axis.
6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2.
7. Adequate cardiac function (LVEF≥50%).
8. Adequate hematological function: absolute neutrophil count(ANC) ≥1.5\*109/L and platelet count(PLT) ≥75\*109/L.
9. Fertile patients must use effective contraception during the treatment and within 3 months after the treatment.
10. Signed an informed consent form which was approved by the institutional review board of the respective medical center.

Exclusion Criteria:

1. Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
2. Known allergic reactions against any component of CHOP regimen.
3. Previous treatment for DLBCL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, monoclonal antibody therapy or surgical treatment (excluding lymph node biopsies and surgical resection for non-lymphoma lesions).
4. History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis), or prior use of any monoclonal antibody within 3 months.
5. Primary central nervous system(CNS) lymphoma, secondary CNS involvement, grey zone lymphoma (GZL) between burkitt and DLBCL, primary effusion lymphoma, plasmablastic lymphoma, primary cutaneous DLBCL, anaplastic lymphoma kinase(ALK) positive DLBCL or transformed lymphoma.
6. History of other cancer within the past 5 years except cured basal cell skin cancer, squamous cell carcinoma, cutaneous melanoma or carcinoma in situ of the cervix.
7. Patients who have significant cardiac disease, including heart disease of grade Ⅲ of Ⅳ according to the New York Heart Association(NYHA) system, or occurrence of myocardial infarction, unstable arrhythmia, unstable angina or severe hypertension in the past 6 months or peripheral nervous system(PNS) or CNS disease.
8. Previously suffered from progressive multifocal leukoencephalopathy.
9. Having continuous treatment of corticosteroid drugs lasting for more than 10 days:

   Prednisone with the dosage over 30mg/day; Other corticosteroid drugs with equal dosage.
10. Participation in another clinical trial in the past 3 months.
11. Recent major surgery within 4 weeks.
12. Use of hemopoietic cytokine in the past 2 weeks, e.g. granulocyte colony stimulating factor(G-CSF).
13. Vaccination with a attenuated live vaccine within 4 weeks.
14. Abnormal laboratory values:

    Creatinine more than 1.5 times normal value; Aspartate aminotransferase(AST) or alanine aminotransferase(ALT) more than 2.5 times normal value (5 times if hepatic involvement); total bilirubin(T-BIT) more than 1.5 times normal value(3 times if hepatic involvement); Without anticoagulant therapy, partial thromboplastin time(PTT), activated partial thromboplastin time(APTT) or international normalized ratio(INR) more than 1.5 times normal value.
15. Active Infectious disease or significant infections requiring intravenous antibiotic therapy or hospitalization in the past 4 weeks (exception of tumor induced fever).
16. Suspected active or latent tuberculosis.
17. Seropositive for human immunodeficiency virus (HIV) or hepatitis C antibodies. Hepatitis B virus(HBV) positive patient (including positive hepatitis B surface antigen or positive hepatitis B virus core antibody) may participate if his serum HBV DNA level is sufficient low.
18. Other disease or symptom by the investigator's discretion.

Primary outcomes:
measure: Overall response rate(ORR) after completion of treatment
timeFrame: 18 weeks
Secondary outcomes:
measure: Complete remission(CR) plus complete remission/unconfirmed(CRu) after completion of treatment
timeFrame: 18 weeks
measure: Progression-free survival(PFS)
timeFrame: 1 year
measure: Event-free survival(EFS) at 1 year and directly after an event, whichever comes first. The events are defined as progressive disease, relapse, death from any cause, or new anticancer treatment
timeFrame: 1 year
measure: Duration of remission(DOR) measured from prior achievement of complete remission or partial remission to occurrence of an event or at 1 year, whichever comes first. The events are defined as progressive disease, relapse of death from any cause
timeFrame: 1 year
measure: Overall survival(OS)
timeFrame: 1 year
measure: Comparison of adverse events(AEs) between the two study arms
timeFrame: 1 year
measure: Number of participants with seropositive for human anti-chimeric antibody(HACA) between the two study arms
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing， China
name: Yuan kai Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References: