NCT02456207

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2014

Enrollment Period

7 months

First QC Date

May 24, 2015

Last Update Submit

May 27, 2015

Conditions

B-cell Non Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Area under the curve (AUC) for SCT400 and rituximab concentrations

    85 days

Secondary Outcomes (5)

  • AUC for SCT400 and rituximab concentrations

    1 week ,2 weeks, 4 weeks, 8 weeks and 12 weeks

  • Maximum observed concentration of the SCT400 and rituximab

    85 days

  • Change from baseline of CD19+ , CD20+ B-cells

    85 days

  • Comparison of AEs between the two study arms

    85 days

  • Comparison of HACA between the two study arms

    85 days

Study Arms (2)

Experimental

EXPERIMENTAL

SCT400:375 mg/m2, iv, one infusion

Drug: SCT400

Active Comparator

ACTIVE COMPARATOR

Rituximab: 375 mg/m2, iv, one infusion

Drug: Rituximab

Interventions

SCT400DRUG
Experimental
RituximabDRUG
Active Comparator

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100076, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2015

First Posted

May 28, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 28, 2015

Record last verified: 2014-05

Locations

CN(1)