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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060410
First Posted: February 2, 2010
Last Update Posted: June 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Wenying Shu, Sun Yat-sen University
  Purpose
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.

Condition Intervention
Lupus Erythematosus, Systemic Adverse Effects Genetic: Polymorphism Analysis Drug: Cyclophosphamide Other: Pharmacokinetic analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Exploration of Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus Treatment

Resource links provided by NLM:


Further study details as provided by Wenying Shu, Sun Yat-sen University:

Biospecimen Retention:   Samples With DNA
Whole blood for DNA extraction as well as for pharmacokinetic studies

Enrollment: 222
Study Start Date: May 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
SLE patients receiving treatment with cyclophosphamide
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060410


Locations
China, Guangdong
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
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
  More Information

Additional Information:
Responsible Party: Wenying Shu, Ph.D., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01060410     History of Changes
Other Study ID Numbers: 30873124-CTX2008
First Submitted: February 1, 2010
First Posted: February 2, 2010
Last Update Posted: June 20, 2012
Last Verified: June 2012

Keywords provided by Wenying Shu, Sun Yat-sen University:
Myelosuppression
Infection
Nausea

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists