NCT03456466

Brief Summary

Primary Outcome Measures: Area under the curve (AUC) forTQB2303 and rituximab concentrations \[ Time Frame: 85 days \] Secondary Outcome Measures: The Maximum Concentration (Cmax) of the TQB2303 and rituximab \[ Time Frame: 85 days \] The area under the plasma concentration-time curve from 0 to inf (infinite) time (AUC0-∞); The time to reach the maximum plasma concentration after treatment (Tmax) Total clearance (CL); Elimination of half-life (t1 / 2); Apparent distribution volume (Vd).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

May 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

December 23, 2017

Last Update Submit

March 5, 2018

Conditions

Non-hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (7)

  • AUC

    Area under the curve (AUC) forTQB2303 and rituximab concentrations

    85 days

  • Cmax

    The Maximum Concentration (Cmax) of the TQB2303 and rituximab

    85 days

  • AUC0-∞

    The area under the plasma concentration-time curve from 0 to inf (infinite) time

    85 days

  • Tmax

    The time to reach the maximum plasma concentration after treatment

    85 days

  • CL

    Total clearance

    85 days

  • t1/2

    Elimination of half-life

    85 days

  • Vd

    Apparent distribution volume

    85 days

Secondary Outcomes (2)

  • Evaluation of immunogenicity

    85 days

  • Change of CD19+ CD20+ B-cells from baseline

    85 days

Study Arms (2)

TQB2303

EXPERIMENTAL
Drug: TQB2303

Rituximab

ACTIVE COMPARATOR
Drug: Rituximab

Interventions

TQB2303DRUG

375mg/m2 ，iv

TQB2303
RituximabDRUG

375mg/m2 ，iv

Rituximab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients should participate in the study voluntarily and sign informed consent;
  • CD20-positive non-Hodgkin's lymphoma (NHL)：Diffuse Large B-cell Lymphoma；Mantle Cell Lymphoma；Follicular Lymphoma；Marginal Zone Lymphoma;
  • having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;And the investigators believe that CD20-positive B-cell NHL patients can benefit from anti-CD20 monoclonal antibody therapy;
  • aged from 18 to 75 years;
  • ECOG PS:0-1；
  • Life expectancy of more than 3 months

You may not qualify if:

  • Had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment;
  • patients who were treated with antitumor therapy (including corticosteroid therapy) within 4 weeks prior to enrollment, or who had not recovered from the toxicity of the previous treatment;
  • Patients who participated in other clinical studies within 30 days ;
  • Serious hematologic dysfunction (white blood cell count of \<3.0×10\^9/L; absolute neutrophil count of \<1.5×10\^9/L; platelet count of \< 75×10\^9/L; hemoglobin level of \<80g/L); In the absence of anticoagulant therapy, International Standardization Ratio (INR)\> 1.5× ULN;Partial prothrombin time (PTT)Or activated partial thromboplastin time (aPTT)\> 1.5 × ULN;) Hepatic dysfunction (total bilirubin level of \> 1.5 × upper limit of normal (ULN); aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \> 2.0 × ULN;) renal dysfunction (serum creatinine level of \> 1.5×ULN );
  • Other invasive malignancies except for cured the IB or lower level of cervical cancer; Non-invasive basal cells or squamous cell skin cancer; Get CR\> 10 years of breast cancer;Get CR\> 10 years of malignant melanoma;or other malignancies with CR\> 5 years;
  • Central nervous system (CNS) lymphoma, AIDS-associated lymphoma;
  • Active infections and other serious non-malignant tumor diseases, Such as Qualitative pneumonia, Severe organic cardiovascular disease, Heart conduction block \> 2,Myocardial infarction in 6 months, Cerebral infarction in 3 months,Cerebral hemorrhage,Thyroid dysfunction (TSH lower than the normal lower limit or higher than the upper limit of normal, and the researchers have a clinical significance);
  • Seropositive for HIV , HCV antibody; Or one of the following HBV findings :
  • HBsAg positive;
  • HBsAg negative, HBcAb positive and HBV DNA positive;
  • Plan major surgery, or surgical wound unhealed patients;
  • History of severe allergies, protein products and mouse products such as allergies;
  • Pregnancy or breast feeding. Companion for women of childbearing age or women of childbearing age,who reluctant to take appropriate contraceptive methods within one year after the last treatment of the study;Pregnancy before pregnancy screening, the women who blood / urine results were positive;
  • Receipt of a live/attenuated vaccine within 4 weeks prior to the Screening Visit;
  • Researchers think that do not fit into the group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms 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 Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: TQB2303 and Rituximab
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2017

First Posted

March 7, 2018

Study Start

May 1, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

CN(2)