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

NCT ID: NCT02456207

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-12-31

Brief 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).

Conditions

B-cell Non Hodgkin's Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

SCT400:375 mg/m2, iv, one infusion

Group Type: EXPERIMENTAL

SCT400

Intervention Type: DRUG

Active Comparator

Rituximab: 375 mg/m2, iv, one infusion

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: DRUG

Interventions

SCT400

Intervention Type: DRUG

Rituximab

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Shuting Li

Role: primary

cancergcp@163.com

010-87788495

Other Identifiers

SCT400NHL2

Identifier Type: -

Identifier Source: org_study_id