NCT02945215

Brief Summary

Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2016

Typical duration for phase_1

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 13, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2019

Completed
Last Updated

September 1, 2020

Status Verified

June 1, 2020

Enrollment Period

2.3 years

First QC Date

October 24, 2016

Last Update Submit

August 30, 2020

Conditions

B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • AUC0-inf of IBI301 and rituximab

    91 days

Secondary Outcomes (8)

  • Peak Plasma Concentration (Cmax)

    91 days

  • Percentage and absolute value of CD19+

    91 days

  • Percentage and absolute value of CD20+ B-cell

    91 days

  • Positive rate of ADA

    91 days

  • Positive rate of NAb

    91 days

  • +3 more secondary outcomes

Study Arms (2)

IBI301

EXPERIMENTAL
Drug: IBI301

Rituximab

ACTIVE COMPARATOR
Drug: Rituximab

Interventions

IBI301DRUG

IBI301 375mg/㎡

IBI301
RituximabDRUG

Rituximab 375mg/㎡

Rituximab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CD20-positive B-cell lymphoma.
  • years to 65 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Signed an informed consent.
  • Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy.

You may not qualify if:

  • Participation in another interventional clinical trial in the past 28 days.
  • Known allergic reactions against monoclonal antibody or rituximab.
  • Rituximab and other anti-CD20 monoclonal antibody used in the past 4 months.
  • Blood concentration of Rituximab\>24ug/ml.
  • HIV positive patients.
  • HCV antigen and antibody positive.
  • Acute and chronic hepatitis B virus infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Beijing cancer hospital

Beijing, Beijing Municipality, China

Location

Peking University third hospital

Beijing, Beijing Municipality, China

Location

The 307th Hospital of Military Medical Sciences

Beijing, Beijing Municipality, China

Location

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Jiangsu province people's hospital

Nanjing, Jiangsu, China

Location

West China Hospital,Sichuan University

Chengdu, Sichuan, China

Location

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital Zhejiang University

Hangzhou, Zhejiang, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Lugui Qiu

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 26, 2016

Study Start

December 13, 2016

Primary Completion

March 21, 2019

Study Completion

October 16, 2019

Last Updated

September 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(12)