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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

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ClinicalTrials.gov Identifier: NCT02772822
Recruitment Status : Unknown
Verified May 2016 by Sinocelltech Ltd..
Recruitment status was:  Not yet recruiting
First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Sinocelltech Ltd.

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date May 16, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
Overall response rate(ORR) after completion of treatment [ Time Frame: 18 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Complete remission(CR) plus complete remission/unconfirmed(CRu) after completion of treatment [ Time Frame: 18 weeks ]
  • Progression-free survival(PFS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]
  • Overall survival(OS) [ Time Frame: 1 year ]
  • Comparison of adverse events(AEs) between the two study arms [ Time Frame: 1 year ]
  • Number of participants with seropositive for human anti-chimeric antibody(HACA) between the two study arms [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B Cell Lymphoma
Intervention  ICMJE
  • Drug: SCT400 plus CHOP
  • Drug: Rituximab plus CHOP
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Drug: Rituximab plus CHOP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772822
Other Study ID Numbers  ICMJE SCT400NHL3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sinocelltech Ltd.
Study Sponsor  ICMJE Sinocelltech Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuan kai Shi, PhD Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing, China
PRS Account Sinocelltech Ltd.
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP