Clinical trial NCT02456207: A Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: B-cell Non Hodgkin's Lymphoma
Lead sponsor: Sinocelltech Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Area under the curve (AUC) for SCT400 and rituximab concentrations
timeFrame: 85 days
Secondary outcomes:
measure: AUC for SCT400 and rituximab concentrations
timeFrame: 1 week ,2 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Maximum observed concentration of the SCT400 and rituximab
timeFrame: 85 days
measure: Change from baseline of CD19+ , CD20+ B-cells
timeFrame: 85 days
measure: Comparison of AEs between the two study arms
timeFrame: 85 days
measure: Comparison of HACA between the two study arms
timeFrame: 85 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: