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Trial record 1 of 1 for:    CIBI301A301
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A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients

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ClinicalTrials.gov Identifier: NCT02867566
Recruitment Status : Unknown
Verified August 2016 by Innovent Biologics (Suzhou) Co. Ltd..
Recruitment status was:  Recruiting
First Posted : August 16, 2016
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Study Description
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Brief Summary:
The purpose of this study is to comparing the Efficacy and Safety between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients.

Condition or disease Intervention/treatment Phase
Diffuse, Large B-Cell, Lymphoma Drug: IBI301 plus CHOP Drug: Rituximab plus CHOP Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Controlled, Phase III Study to Evaluate the Efficacy and Safety of IBI301 (Recombinant Chimeric Anti-CD20 Monoclonal Antibody ) in Combination With CHOP Regimen Versus Rituximab in Combination With CHOP Regimen in Treatment-naïve Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: IBI301
IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
 Drug: IBI301 plus CHOP
Six cycles. IBI301: 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; Vindesine: 4 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle.
Active Comparator: Rituximab
Rituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
 Drug: 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; Vindesine: 4 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate(ORR) [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Complete remission(CR) [ Time Frame: 18 weeks ]
  2. Progression-free survival(PFS) [ Time Frame: 1 year ]
  3. Event-free survival(EFS) [ Time Frame: 1 year ]
  4. Overall survival(OS) [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Untreated CD20-positive DLBCL confirmed by histopathology or cytology.
  • 18 years to 70 years; Male or female patients.
  • International Prognostic Index (IPI) score of 0 to 2.
  • Signed an informed consent.
  • At least one measurable lesions: 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.
  • More than 6 months life expectancy.

Exclusion Criteria:

  • Participation in another interventional clinical trial in the past 3 months.
  • Known allergic reactions against monoclonal antibody or rituximab.
  • Contraindication to any component of CHOP regimen.
  • Previous treatment for DLBCL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, or surgical treatment (excluding tumor mass biopsies and surgical resection for non-lymphoma lesions), or prior use of any monoclonal antibody within 3 month.
  • History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis).
  • Primary central nervous system (CNS) lymphoma, secondary CNS involvement, primary testicular lymphoma.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867566


Contacts
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Contact: Hui Zhou 8651269566088 ext 8067 hui.zhou@innoventbio.com

Locations
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China
Institute of Hematology; Chinese Academy of Medical Sciences Recruiting
Tianjin, China
Contact: Lugui Qiu, Prof    13821266636      
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Investigators
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Principal Investigator: Lugui Qiu Hematology Hospital of Chinese Academy of Medical Sciences
More Information
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT02867566     History of Changes
Other Study ID Numbers: CIBI301A301
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents