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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

Description:

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).

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: SCT400NHL3
  • NCT ID: NCT02772822

Conditions

  • Diffuse Large B Cell Lymphoma

Interventions

DrugSynonymsArms
SCT400 plus CHOPExperimental
Rituximab plus CHOPActive Comparator

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
ExperimentalExperimentalSCT400 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
  • SCT400 plus CHOP
Active ComparatorActive ComparatorRituximab 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
  • Rituximab plus CHOP

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.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate(ORR) after completion of treatment
Time Frame:18 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Complete remission(CR) plus complete remission/unconfirmed(CRu) after completion of treatment
Time Frame:18 weeks
Safety Issue:
Description:
Measure:Progression-free survival(PFS)
Time Frame:1 year
Safety Issue:
Description:
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
Time Frame:1 year
Safety Issue:
Description:
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
Time Frame:1 year
Safety Issue:
Description:
Measure:Overall survival(OS)
Time Frame:1 year
Safety Issue:
Description:
Measure:Comparison of adverse events(AEs) between the two study arms
Time Frame:1 year
Safety Issue:
Description:
Measure:Number of participants with seropositive for human anti-chimeric antibody(HACA) between the two study arms
Time Frame:1 year
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sinocelltech Ltd.

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