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A Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

A Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma

A Phase II, Multi-center, Randomized and Open Study to Evaluate and Compare the PK, PD and Safety of SCT400 With Rituximab in Patients With CD20+ B-cell Non-Hodgkin's Lymphoma

NCT02456207•Sinocelltech Ltd.

View on ClinicalTrials.gov

Summary

The primary objective of the study is to assess the pharmacokinetic (PK) similarity of SCT400 versus rituximab (MabThera®) in patients with CD20+ B-cell Non-Hodgkin's Lymphoma. The secondary objective of the study is to evaluate the pharmacodynamics (PD) and safety of SCT400 versus rituximab (MabThera®), as well as the presence of human anti-chimeric antibodies (HACA).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. aged from 18 to 75 years;
•2. having histologically confirmed NHL expressing CD20 antigen;
•3. having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;
•4. ECOG performance status of 0 to 1
•5. expected survival of at least ≥ 3 months;
•6. signed an informed consent form which was approved by the institutional review board of the respective medical center .

Exclusion Criteria

•1. had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment;
•2. having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy;
•3. participating in other clinical trial within 30 days before enrolment;
•4. with serious hematologic dysfunction (white blood cell count of \<3.0×103/uL; absolute neutrophil count of \<1.5×103/ uL; platelet count of \< 75×103/uL; hemoglobin level of \< 8.0 g/dL); hepatic dysfunction (total bilirubin level of \> 1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \>2.5 × ULN; renal dysfunction (serum creatinine level of \> 1.5×ULN ); and International normalized ratio (INR) and partial thromboplastin time or activated partial thromboplastin time (aPTT) \> 1.5 × ULN (unless on therapeutic coagulation);
•5. had received live vaccine within 4 weeks prior to study entry;
•6. with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related lymphoma; or active opportunistic infection, a serious nonmalignant disease;
•7. seropositive for HCV antibody, or HIV antibody, or hepatitis B virus surface antigen (HBsAg). HBc antibody seropositive, but HBV DNA and HBsAg negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated,
•8. recent major surgery (within 28 days prior to study entry );
•9. with a history of allergic reaction or protein product allergy including murine proteins;
•10. pregnant or lactating or not accepted birth control methods including male patients.

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Key Dates

Start Date

May 1, 2015

Primary Completion Date

December 1, 2015

Completion Date

December 1, 2015

Last Updated

May 28, 2015

Enrollment

ESTIMATED participants

Conditions

B-cell Non Hodgkin's Lymphoma

Interventions

SCT400

DRUG

Rituximab

DRUG

Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and Rituximab in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL

NCT02787239

B-cell Non Hodgkin's Lymphoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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