Back to resultsA Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
Primary Purpose
B-cell Non Hodgkin's Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SCT400
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Non Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria:
- aged from 18 to 75 years;
- having histologically confirmed NHL expressing CD20 antigen;
- having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;
- ECOG performance status of 0 to 1
- expected survival of at least ≥ 3 months;
- signed an informed consent form which was approved by the institutional review board of the respective medical center .
Exclusion Criteria:
- had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment;
- having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy;
- participating in other clinical trial within 30 days before enrolment;
- 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);
- had received live vaccine within 4 weeks prior to study entry;
- with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related lymphoma; or active opportunistic infection, a serious nonmalignant disease;
- 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,
- recent major surgery (within 28 days prior to study entry );
- with a history of allergic reaction or protein product allergy including murine proteins;
- pregnant or lactating or not accepted birth control methods including male patients.
Sites / Locations
- Cancer Hospital Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Active Comparator
Arm Description
SCT400:375 mg/m2, iv, one infusion
Rituximab: 375 mg/m2, iv, one infusion
Outcomes
Primary Outcome Measures
Area under the curve (AUC) for SCT400 and rituximab concentrations
Secondary Outcome Measures
AUC for SCT400 and rituximab concentrations
Maximum observed concentration of the SCT400 and rituximab
Change from baseline of CD19+ , CD20+ B-cells
Comparison of AEs between the two study arms
Comparison of HACA between the two study arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02456207
Brief Title
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
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinocelltech Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Non Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
SCT400:375 mg/m2, iv, one infusion
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Rituximab: 375 mg/m2, iv, one infusion
Intervention Type
Drug
Intervention Name(s)
SCT400
Intervention Type
Drug
Intervention Name(s)
Rituximab
Primary Outcome Measure Information:
Title
Area under the curve (AUC) for SCT400 and rituximab concentrations
Time Frame
85 days
Secondary Outcome Measure Information:
Title
AUC for SCT400 and rituximab concentrations
Time Frame
1 week ,2 weeks, 4 weeks, 8 weeks and 12 weeks
Title
Maximum observed concentration of the SCT400 and rituximab
Time Frame
85 days
Title
Change from baseline of CD19+ , CD20+ B-cells
Time Frame
85 days
Title
Comparison of AEs between the two study arms
Time Frame
85 days
Title
Comparison of HACA between the two study arms
Time Frame
85 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged from 18 to 75 years;
having histologically confirmed NHL expressing CD20 antigen;
having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;
ECOG performance status of 0 to 1
expected survival of at least ≥ 3 months;
signed an informed consent form which was approved by the institutional review board of the respective medical center .
Exclusion Criteria:
had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment;
having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy;
participating in other clinical trial within 30 days before enrolment;
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);
had received live vaccine within 4 weeks prior to study entry;
with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related lymphoma; or active opportunistic infection, a serious nonmalignant disease;
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,
recent major surgery (within 28 days prior to study entry );
with a history of allergic reaction or protein product allergy including murine proteins;
pregnant or lactating or not accepted birth control methods including male patients.
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100076
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuting Li
Phone
010-87788495
Email
cancergcp@163.com
12. IPD Sharing Statement
Learn more about this trial
A Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
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