Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
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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 |
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| Ages Eligible for Study: | 12 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
SLE patients receiving treatment with cyclophosphamide
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| China, Guangdong | |
| Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University | |
| Guangzhou, Guangdong, China, 510080 | |
| 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:
No publications provided
| Responsible Party: | Wenying Shu, Ph.D., Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01060410 History of Changes |
| Other Study ID Numbers: | 30873124-CTX2008 |
| Study First Received: | February 1, 2010 |
| Last Updated: | June 18, 2012 |
| Health Authority: | China: National Natural Science Foundation |
Keywords provided by 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 |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 19, 2013