A Pharmacokinetic and Pharmacodynamic Study Comparing HLX01 And Rituximab in Patients With CD20-Positive, B-cell Lymphoma

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

Study Overview

• Status: Completed
• Conditions: B-cell Non Hodgkin's Lymphoma
• Intervention / Treatment: Drug: Rituximab; Drug: HLX01

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Other invasive malignancies within 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix;
2. Chemotherapy within 1 month;
3. Had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 month before enrollment;
4. Had received rituximab or other anti-CD20(+) monoclonal antibody treatment 1 month ago but with ADA(+) before enrollment;
5. Blood concentration of Rituximab> 24 μg/ml prior to study entry;
6. Had received hematopoitic growth factor within 1 week prior to study entry;
7. Receipt of a live/attenuated vaccine within 4 weeks prior to the Screening Visit;
8. Recent major surgery (within 8 weeks prior to screening, excluding lymph node biopsy);
9. Peripheral or central nervous system disease;
10. 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);
11. 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 );
12. Abnormal thyroid function;
13. Seropositive for HIV , HCV antibody; seropositive for hepatitis B virus surface antigen (HBsAg). HBV DNA>1.0×103copies/ml;
14. 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);
15. Pregnancy or breast feeding. For women of childbearing potential.
16. History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial drug.
17. Subjects had a history of alcoholism or drug abuse;
18. Researchers think that do not fit into the group.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLX01; 375mg/m2 iv single dose	Drug: HLX01
Active Comparator: Rituximab; 375mg/m2 iv single dose	Drug: Rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve (AUC) for HLX01 and rituximab concentrations	91 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 21, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: HLX01-NHL02