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

June 18, 2012 updated by: Wenying Shu, Sun Yat-sen University

Exploration of Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cyclophosphamide is a widely applied agent in treatment of systemic lupus erythematosus. As an alkylating agent, cyclophosphamide is able to induce several side effects, including thinned hair, loss of appetite, nausea, vomiting, infection, myelosuppression, etc. However, the remarkable variability of the reactions to the drug -- the incidence of side effect or the outcome of the treatment -- has been observed among patients. Cyclophosphamide is a pro-drug, which require some enzymes in the liver to transform it into an active chemical to arouse alkylating function. And then it undergoes a series of detoxification steps catalyzed by the specific metabolic enzymes. This study is designed to explore the genetic variation among individuals in the key processes of the activation and elimination of cyclophosphamide in order to find out whether these genetic factors are associated to the side effects or efficacy. The further understanding into the factors concerning on the drug might imply possible solution to minimize the incidence of side effects in patients of systemic lupus erythematosus.

Study Type

Observational

Enrollment (Actual)

222

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University

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

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

SLE patients receiving treatment with cyclophosphamide

Description

Inclusion Criteria:

  1. The patients must have been diagnosed as SLE according to the American College of Rheumatology (ACR) criteria published in 1997.
  2. 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.
  3. The patients are receiving the standard regimen of 0.2g cyclophosphamide given as intravenous injection once every two days.

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cyclophosphamide,low dose,continuous
Genetic: Polymorphism Analysis
Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the bio-activation and elimination of cyclophosphamide
Drug: Cyclophosphamide
intravenous injection, 0.2g, once every two days
Other: Pharmacokinetic analysis
laboratory analysis of concentration of cyclophosphamide and 4-OH-cyclophosphamide in plasma

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Chair: Min Huang, PhD., Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
  • Study Director: Xueding Wang, PhD., Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
  • Principal Investigator: Wenying Shu, PhD., Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
  • Study Director: Xiuyan Yang, MD., Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
  • Principal Investigator: Liuqin Liang, MD., Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30873124-CTX2008

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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