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

NCT ID: NCT02584920

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-08-31

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.

Conditions

B-cell Non Hodgkin's Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HLX01

375mg/m2 iv single dose

Group Type: EXPERIMENTAL

HLX01

Intervention Type: DRUG

Rituximab

375mg/m2 iv single dose

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: DRUG

Interventions

HLX01

Intervention Type: DRUG

Rituximab

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 34321836 (View on PubMed)

Other Identifiers

HLX01-NHL02

Identifier Type: -

Identifier Source: org_study_id