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

May 27, 2015 updated by: Sinocelltech Ltd.

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100076
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
SCT400:375 mg/m2, iv, one infusion
Drug: SCT400
Active Comparator: Active Comparator
Rituximab: 375 mg/m2, iv, one infusion
Drug: Rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve (AUC) for SCT400 and rituximab concentrations
Time Frame: 85 days
85 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of AEs between the two study arms
Time Frame: 85 days
85 days
AUC for SCT400 and rituximab concentrations
Time Frame: 1 week ,2 weeks, 4 weeks, 8 weeks and 12 weeks
1 week ,2 weeks, 4 weeks, 8 weeks and 12 weeks
Maximum observed concentration of the SCT400 and rituximab
Time Frame: 85 days
85 days
Change from baseline of CD19+ , CD20+ B-cells
Time Frame: 85 days
85 days
Comparison of HACA between the two study arms
Time Frame: 85 days
85 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinocelltech Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 24, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCT400NHL2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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