A Study 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

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• IBI301 plus CHOP — DRUG
  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.
• Rituximab plus CHOP — DRUG
  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.

Study Details

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.

Key Dates

Start date

Aug 22, 2016

Status verified

Aug 2016

Primary completion

Sep 5, 2019

Completion

Dec 26, 2019

Study Design

Enrollment

420 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: IBI301
  IBI301, 375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
• Active Comparator: Rituximab
  Rituximab,375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)

Primary Outcome Measure

Overall response rate(ORR) [ Time Frame: 18 weeks ]