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

NCT02772822 | Unknown Phase 3

• 1 other identifier: SCT400NHL3
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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).

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate(ORR) after completion of treatment

  18 weeks

Secondary Outcomes (7)

• Complete remission(CR) plus complete remission/unconfirmed(CRu) after completion of treatment

  18 weeks

• Progression-free survival(PFS)

  1 year

• 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

  1 year

• 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

  1 year

• Overall survival(OS)

  1 year

Study Arms (2)

Experimental

EXPERIMENTAL

SCT400 plus CHOP, six cycles SCT400: 375 mg/m2, IV, day 1 of each cycle Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle Doxorubicin: 50 mg/m2, IV, day 2 of each cycle Vincristine: 1.4 mg/m2, up to a maximal dose of 2 mg, IV, day 2 of each cycle Prednisone: 100 mg, po, day 2 to day 6 of each cycle

Drug: SCT400 plus CHOP

Active Comparator

ACTIVE COMPARATOR

Rituximab plus CHOP, six cycles Rituximab: 375 mg/m2, IV, day 1 of each cycle Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle Doxorubicin: 50 mg/m2, IV, day 2 of each cycle Vincristine: 1.4 mg/m2, up to a maximal dose of 2 mg, IV, day 2 of each cycle Prednisone: 100 mg, po, day 2 to day 6 of each cycle

Drug: Rituximab plus CHOP

Interventions

SCT400 plus CHOP DRUG

Experimental

Rituximab plus CHOP DRUG

Active Comparator

Eligibility Criteria

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

You may qualify if:

• Untreated CD20-positive DLBCL confirmed by local histopathology.
• 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.
• years to 70 years; Male or female patients.
• More than 6 months life expectancy.
• 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.
• Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2.
• Adequate cardiac function (LVEF≥50%).
• Adequate hematological function: absolute neutrophil count(ANC) ≥1.5\*109/L and platelet count(PLT) ≥75\*109/L.
• Fertile patients must use effective contraception during the treatment and within 3 months after the treatment.
• Signed an informed consent form which was approved by the institutional review board of the respective medical center.

You may not qualify if:

• Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
• Known allergic reactions against any component of CHOP regimen.
• 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).
• 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.
• 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.
• 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.
• 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.
• Previously suffered from progressive multifocal leukoencephalopathy.
• 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.
• Participation in another clinical trial in the past 3 months.
• Recent major surgery within 4 weeks.
• Use of hemopoietic cytokine in the past 2 weeks, e.g. granulocyte colony stimulating factor(G-CSF).
• Vaccination with a attenuated live vaccine within 4 weeks.
• Abnormal laboratory values:

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100076, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yuan kai Shi, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing， China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 16, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 16, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)