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

B-cell Non Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02456207
• Other study ID #: SCT400NHL2
• Status: Recruiting
• Phase: Phase 2
• First received: May 24, 2015
• Last updated: May 27, 2015
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2014
• Source: Sinocelltech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-cell Non Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• SCT400

• Rituximab

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sinocelltech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) for SCT400 and rituximab concentrations		85 days	No
Secondary	AUC for SCT400 and rituximab concentrations		1 week ,2 weeks, 4 weeks, 8 weeks and 12 weeks	No
Secondary	Maximum observed concentration of the SCT400 and rituximab		85 days	No
Secondary	Change from baseline of CD19+ , CD20+ B-cells		85 days	No
Secondary	Comparison of AEs between the two study arms		85 days	Yes
Secondary	Comparison of HACA between the two study arms		85 days	Yes