Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment

NCT01060410 | Completed

• 1 other identifier: 30873124-CTX2008
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the relationship between the side effects of cyclophosphamide in the treatment of systemic lupus erythematosus (SLE) in Han Chinese and the genetic polymorphisms of drug metabolizing enzymes and pharmacokinetics of cyclophosphamide.

Conditions

Lupus Erythematosus, Systemic; Adverse Effects

Keywords

Myelosuppression; Infection; Nausea

Study Arms (1)

Cyclophosphamide,low dose,continuous

Genetic: Polymorphism Analysis; Drug: Cyclophosphamide; Other: Pharmacokinetic analysis

Interventions

Polymorphism Analysis GENETIC

Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the bio-activation and elimination of cyclophosphamide

Cyclophosphamide,low dose,continuous

Cyclophosphamide DRUG

intravenous injection, 0.2g, once every two days

Cyclophosphamide,low dose,continuous

Pharmacokinetic analysis OTHER

laboratory analysis of concentration of cyclophosphamide and 4-OH-cyclophosphamide in plasma

Cyclophosphamide,low dose,continuous

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SLE patients receiving treatment with cyclophosphamide

You may qualify if:

• The patients must have been diagnosed as SLE according to the American College of Rheumatology (ACR) criteria published in 1997.
• The patients must sign the informed consent. And for the patients who are under 18 years old, both the signatures of their legal guardians and that of the patients are required on the written informed consent.
• The patients are receiving the standard regimen of 0.2g cyclophosphamide given as intravenous injection once every two days.

You may not qualify if:

• Pregnant women, women in breast-feeding period and the women who refuse to take contraception measures during treatment.
• Patients with poor compliance.
• Patients who are also diagnosed of cancer or who are receiving cyclophosphamide in treatment of cancer, or other anti-cancer therapy.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Links

• Systemic lupus erythematosus
• Help Me Understand Genetics
• Cytochrome P450
• Cyclophosphamide
• Understanding Drug Therapy and Managing Side Effects

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for DNA extraction as well as for pharmacokinetic studies

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Infections; Nausea

Interventions

Amplified Fragment Length Polymorphism Analysis; Cyclophosphamide

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DNA Fingerprinting; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Min Huang, PhD.

  Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

  STUDY CHAIR

• Xueding Wang, PhD.

  Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

  STUDY DIRECTOR

• Wenying Shu, PhD.

  Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

  PRINCIPAL INVESTIGATOR

• Xiuyan Yang, MD.

  Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

  STUDY DIRECTOR

• Liuqin Liang, MD.

  Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 2, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

CN (1)