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A Study to Evaluate Safety, Tolerability, PK and PD of HLX01 in Patients With CD20-positive B-cell Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03218072
Recruitment Status : Completed
First Posted : July 14, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Tracking Information
First Submitted Date  ICMJE July 7, 2017
First Posted Date  ICMJE July 14, 2017
Last Update Posted Date July 19, 2017
Actual Study Start Date  ICMJE May 4, 2014
Actual Primary Completion Date January 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
  • AEs [ Time Frame: From First infusion to Day 90 ]
    The type, severity and incidence of adverse events
  • SAEs [ Time Frame: From First infusion to Day 90 ]
    Thetype, severity and incidence of SAEs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
  • AUC0-inf [ Time Frame: From First administration to Day 90 ]
    Area under the serum concentration-time curve from time 0 extrapolated to infinity
  • Cmax [ Time Frame: From First administration to Day 90 ]
    Maximum serum concentration
  • t1/2 [ Time Frame: From First administration to Day 90 ]
    terminal half-life
  • CD19 positive B cells [ Time Frame: From First administration to Day 90 ]
    The count of CD19 positive in peripheral blood
  • CD20 positive B cells [ Time Frame: From First administration to Day 90 ]
    The count of CD20 positive in peripheral blood
  • Antidrug antibodies of HLX01 [ Time Frame: From First administration to Day 90 ]
    The concentration of anti-HLX01 in serum
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
  • AUC0-inf [ Time Frame: From First administion to Day 90 ]
    Area under the serum concentration-time curve from time 0 extrapolated to infinity
  • Cmax [ Time Frame: From First administion to Day 90 ]
    Maximum serum concentration
  • t1/2 [ Time Frame: From First administion to Day 90 ]
    terminal half-life
  • CD19 positive B cells [ Time Frame: From First administion to Day 90 ]
    The count of CD19 positive in peripheral blood
  • CD20 positive B cells [ Time Frame: From First administion to Day 90 ]
    The count of CD20 positive in peripheral blood
  • Antidrug antibodies of HLX01 [ Time Frame: From First administion to Day 90 ]
    The concentration of anti-HLX01 in serum
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety, Tolerability, PK and PD of HLX01 in Patients With CD20-positive B-cell Lymphomas
Official Title  ICMJE A Phase Ia, Multi-centers, Open-label, Dose-escalation Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HLX01 (a Potential Rituximab Biosimilar) in Patients With CD20-positive B-cell Lymphomas
Brief Summary To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.
Detailed Description This was a phase Ia, multicenter, open-label, dose-escalation clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of HLX01 injection in patients with CD20-positive B-cell lymphomas.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B-cell Lymphomas
Intervention  ICMJE Drug: HLX01
a potential rituximab biosimilar
Study Arms  ICMJE
  • Experimental: HLX01 250 mg/m2
    HLX01 250 mg/m2 administrated intravenously
    Intervention: Drug: HLX01
  • Experimental: HLX01 375 mg/m2
    HLX01 375 mg/m2 administrated intravenously
    Intervention: Drug: HLX01
  • Experimental: HLX01 500 mg/m2
    HLX01 500 mg/m2 administrated intravenously
    Intervention: Drug: HLX01
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2017)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2015
Actual Primary Completion Date January 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years ≤ aged ≤ 65 years, male or female;
  • having histologically confirmed diagnosis of relapsed/refractory CD20-positive B-cell lymphomas which needed consolidation therapy;
  • Eastern Cooperative Oncology Group (ECOG) performance status≤1 and life expectancy ≥3 months;
  • providing signed and dated informed consents.

Exclusion Criteria:

  • Usage of rituximab or other anti-CD20 monoclonal antibody within 2 years before enrollment;
  • usage of hematopoietic cytokines within 1 week before enrollment, e.g. granulocyte colony stimulating factor (G-CSF);
  • recent major surgery (excluding diagnostic surgery) within the past 8 weeks;
  • peripheral nervous system diseases or central nervous system diseases;
  • inadequate hematologic function met any of the following at screening: white blood cell count <3.0×109/L, absolute neutrophil count (lobocyte and rhabdocyte) <1.5×109/L, platelet count <100×109/L, hemoglobin <90 g/L, for patients with bone marrow involvement, absolute neutrophil count (lobocyte and rhabdocyte) <1.0×109/L, platelet count <75×109/L, hemoglobin <80 g/L;
  • inadequate liver function met any of the following at screening: total bilirubin>1.5×the upper limit of normal range (ULN), ALT or AST>2.0×ULN, alkaline phosphatase (ALP)>3.0×ULN;
  • abnormal renal function (serum creatinine>1.5×ULN);
  • abnormal thyroid function (TSH< lower limit of normal or > upper limit of normal with clinical significance judged by investigators);
  • positive test result(s) for serum HIV antigen or antibody;
  • seropositivity of HBsAg, or seropositivity of HBcAb and HBV DNA>ULN; seropositivity of Anti HCV antibody;
  • history of herpes zoster and left with sequelae or latent infection;
  • other serious disease which may restrict subjects to participate in the trial (such as ongoing active infection, uncontrolled diabetes mellitus, severe cardiac insufficiency or angina pectoris, gastric ulcer, active autoimmune disease, etc.);
  • pregnancy or breast feeding female, or not willing to use effective contraceptive measures during the study;
  • allergic constitution, or known allergic to components of rituximab or other anti-CD20 monoclonal antibody;
  • history of alcoholism or drug abuse; participation in other clinical trials within 3 months before enrollment;
  • not suitable for enrollment at investigator's discretion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03218072
Other Study ID Numbers  ICMJE HLX01-NHL01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shanghai Henlius Biotech
Study Sponsor  ICMJE Shanghai Henlius Biotech
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Henlius Biotech
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP