NCT02584920

Brief Summary

Randomised, double-blind, parallel group study to compare PK and PD profiles between HLX01 and rituximab (MabThera®) in patients with CD20+ B-cell Lymphoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2014

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

Study Start

First participant enrolled

October 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

October 21, 2015

Last Update Submit

May 4, 2022

Conditions

B-cell Non Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Area under the curve (AUC) for HLX01 and rituximab concentrations

    91 days

Secondary Outcomes (3)

  • The Maximum Concentration (Cmax) of the HLX01 and rituximab

    91 days

  • Presence of Anti-Drug Antibodies against HLX01

    91 days

  • Change from baseline of CD19+ B-cells

    91 days

Study Arms (2)

HLX01

EXPERIMENTAL

375mg/m2 iv single dose

Drug: HLX01

Rituximab

ACTIVE COMPARATOR

375mg/m2 iv single dose

Drug: Rituximab

Interventions

HLX01DRUG
HLX01
RituximabDRUG
Rituximab

Eligibility Criteria

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

You may qualify if:

  • aged from 18 to 65 years;
  • CD20-positive non-Hodgkin's lymphoma (NHL);
  • having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;
  • ECOG performance status of \<=1, expected survival of at least \>= 3 months;
  • Peripheral blood lymphocyte count \< 5×10\^9/L
  • signed an informed consent form which was approved by the institutional review board of the respective medical center .

You may not qualify if:

  • Other invasive malignancies within 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix;
  • Chemotherapy within 1 month;
  • Had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 month before enrollment;
  • Had received rituximab or other anti-CD20(+) monoclonal antibody treatment 1 month ago but with ADA(+) before enrollment;
  • Blood concentration of Rituximab\> 24 μg/ml prior to study entry;
  • Had received hematopoitic growth factor within 1 week prior to study entry;
  • Receipt of a live/attenuated vaccine within 4 weeks prior to the Screening Visit;
  • Recent major surgery (within 8 weeks prior to screening, excluding lymph node biopsy);
  • Peripheral or central nervous system disease;
  • Serious hematologic dysfunction (white blood cell count of \<3.0×109/L; absolute neutrophil count of \<1.5×109/L; platelet count of \< 100×109/L; hemoglobin level of \< 9.0 g/dL);
  • 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; alkaline phosphatase \> 3.0 × ULN; renal dysfunction (serum creatinine level of \> 1.5×ULN );
  • Abnormal thyroid function;
  • Seropositive for HIV , HCV antibody; seropositive for hepatitis B virus surface antigen (HBsAg). HBV DNA\>1.0×103copies/ml;
  • Serious underlying medical conditions, could impair the ability of the patient to participate in the trial (including but not limited to ongoing active infection, uncontrolled diabetes mellitus, significant cardiac disease, uncontrolled angina, gastric ulcers, active autoimmune disease);
  • Pregnancy or breast feeding. For women of childbearing potential.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shi Y, Zhang Q, Han X, Qin Y, Ke X, Su H, Liu L, Fu J, Jin J, Feng J, Hong X, Zhang X, Wu D, Jiang B, Dong X. Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a rituximab biosimilar) to reference rituximab in Chinese patients with CD20-positive B-cell lymphoma. Chin J Cancer Res. 2021 Jun 30;33(3):405-416. doi: 10.21147/j.issn.1000-9604.2021.03.11.

    PMID: 34321836RESULT

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 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 21, 2015

First Posted

October 23, 2015

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 9, 2022

Record last verified: 2022-05