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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

NCT02867566 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2020-08-12

No results posted yet for this study

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.

Conditions

  • Diffuse, Large B-Cell, Lymphoma

Interventions

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.

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.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Lugui Qiu · Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-22
Primary Completion
2019-09-05
Completion
2019-12-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02867566 on ClinicalTrials.gov