Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.

B-cell Non Hodgkin's Lymphoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206308
• Other study ID #: SCT400NHLI
• Status: Completed
• Phase: Phase 1
• First received: July 30, 2014
• Last updated: July 31, 2014
• Start date: May 2012
• Est. completion date: July 2013

Study information

• Verified date: December 2013
• Source: Sinocelltech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-cell Non Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• Chimeric anti-CD20 monoclonal antibody

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sinocelltech Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to disease progression		up to 27 weeks	No
Primary	Number of participants with infusion-related reaction and with drug-related adverse events.		up to 27 weeks	Yes
Secondary	Area Under the plasma concentration versus time curve (AUC) of SCT400		prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose	Yes