Back to resultsSafety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.
Primary Purpose
B-cell Non Hodgkin's Lymphoma
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Chimeric anti-CD20 monoclonal antibody
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Non Hodgkin's Lymphoma focused on measuring Chimeric anti-CD20 monoclonal antibody(SCT400), escalating doses, safety, pharmacokinetics and pharmacodynamics
Eligibility Criteria
Inclusion Criteria:
- aged from 18 to 75 years
- having histologically confirmed NHL expressing CD20 antigen
- having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 according to WHO scale, and 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:
- single measurable lesion ≥7 cm in diameter
- with serious hematologic dysfunction (white blood cell count of <3.0×103/μL; absolute neutrophil count of <1.5×103/ μL; platelet count of < 75×103/μL; hemoglobin level of < 8.0 g/dL; serum immunoglobulin G(IgG) level of <600 mg/dL);, hepatic dysfunction (total bilirubin level of > 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN (≥5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of > 1.5×ULN )
- having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy
- had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
- had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry
- with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related lymphoma; or active opportunistic infection, a serious nonmalignant disease
- having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or human immunodeficiency virus
- with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days )
- 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
Three escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2，500 mg/m2, once a week for 4 doses;
Outcomes
Primary Outcome Measures
Number of participants with infusion-related reaction and with drug-related adverse events.
Secondary Outcome Measures
Area Under the plasma concentration versus time curve (AUC) of SCT400
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02206308
Brief Title
Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.
Official Title
A Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SCT400, a Recombinant Chimeric Anti-CD20 Monoclonal Antibody，in Patients With CD20+ B-cell Non Hodgkin's Lymphoma.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
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 purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma
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
Keywords
Chimeric anti-CD20 monoclonal antibody(SCT400), escalating doses, safety, pharmacokinetics and pharmacodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
Three escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2，500 mg/m2, once a week for 4 doses;
Intervention Type
Biological
Intervention Name(s)
Chimeric anti-CD20 monoclonal antibody
Other Intervention Name(s)
SCT400
Primary Outcome Measure Information:
Title
Number of participants with infusion-related reaction and with drug-related adverse events.
Time Frame
up to 27 weeks
Secondary Outcome Measure Information:
Title
Area Under the plasma concentration versus time curve (AUC) of SCT400
Time Frame
prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose
Other Pre-specified Outcome Measures:
Title
Time to disease progression
Time Frame
up to 27 weeks
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 relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 according to WHO scale, and 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:
single measurable lesion ≥7 cm in diameter
with serious hematologic dysfunction (white blood cell count of <3.0×103/μL; absolute neutrophil count of <1.5×103/ μL; platelet count of < 75×103/μL; hemoglobin level of < 8.0 g/dL; serum immunoglobulin G(IgG) level of <600 mg/dL);, hepatic dysfunction (total bilirubin level of > 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN (≥5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of > 1.5×ULN )
having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy
had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry
with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related lymphoma; or active opportunistic infection, a serious nonmalignant disease
having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or human immunodeficiency virus
with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days )
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan kai Shi, PhD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing， China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.
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