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Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE (CHORUS)

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.
 
ClinicalTrials.gov Identifier: NCT02444728
Recruitment Status : Unknown
Verified July 2015 by Chinese SLE Treatment And Research Group.
Recruitment status was:  Recruiting
First Posted : May 14, 2015
Last Update Posted : March 9, 2017
Sponsor:
Collaborator:
Peking Union Medical College Hospital
Information provided by (Responsible Party):
Chinese SLE Treatment And Research Group

Study Description
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Brief Summary:
Treating severe thrombocytopenia is a challenge in the management of systemic lupus erythematosus. Although rheumatologists have followed some rules in real practice,there is very few evidence to support the current treatment algorithm. The purpose of this study is to compare the complete remission rate and partial remission rate of cyclophosphamide and hydroxychloroquine for treating severe thrombocytopenia in Chinese SLE patients.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Drug: Hydroxychloroquine Drug: Cyclophosphamide Drug: Azathioprine Drug: Methylprednisolone Phase 3

Detailed Description:
This is a prospective,randomized,open-label,multi-center clinical trial. The aim of this study is to test the efficacy of GC(gluco-corticosteroid)+HCQ(hydroxychloroquine) and GC(glucocorticosteroid)+CTX(cyclophosphamide) with sequential AZA(azathioprine) in the induction and maintenance therapy of severe thrombocytopenia in SLE patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus
Study Start Date : July 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group1:Hydroxychloroquine
Hydroxychloroquine: 100 mg tablets by mouth, 400mg everyday for 12 months Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months
 Drug: Hydroxychloroquine
Hydroxychloroquine 200 mg BID for 12 months
Other Name: Fenle

Drug: Methylprednisolone
Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months
Other Name: meizhuole
Active Comparator: Group 2:Cyclophosphamide

Cyclophosphamide, Azathioprine & Methylprednisolone Cyclophosphamide: 200mg powder intravenous infusion, 1000mg every month for 6 month.

Azathioprine: 100 mg tablets by mouth, everyday for 6 months. Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months

 Drug: Hydroxychloroquine
Hydroxychloroquine 200 mg BID for 12 months
Other Name: Fenle

Drug: Cyclophosphamide
Cyclophosphamide 1000mg intravenous infusion every month for 6 months
Other Name: Huanlinxianan

Drug: Azathioprine
After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months
Other Name: liuzuopiaolin

Drug: Methylprednisolone
Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months
Other Name: meizhuole


Outcome Measures
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Primary Outcome Measures :
  1. complete remission rate [ Time Frame: at 12 month ]
    percentage of patients whose platelet count > 100X109/L


Secondary Outcome Measures :
  1. partial remission rate [ Time Frame: at 12 month ]
    percentage of patients whose platelet increase to >30X109/L or with at least a two folds increase of the baseline(ie, pretreatment) count and the absence of bleeding


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients fulfilled the 1997 ACR modified or SLICC classification criteria of SLE；
  2. New onset thrombocytopenia: platelet count <30X109/L(by both routine test and citric acid anti-coagulated blood count test) within 3 months

Exclusion Criteria:

  1. Thrombocytopenia caused by other reasons, including drugs；
  2. Positive for active HAV(hepatitis A virus)/HBV(hepatitis B virus) infection
  3. Active HIV(human immunodeficiency virus) or HCV(hepatitis C virus) infection;
  4. Active HP(Helicopter pylori) infection;
  5. Severe liver and kidney dysfunction；
  6. Severe neuropsychiatric lupus；
  7. No response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment；
  8. Uncontrolled diabetes or hypertension before entry
  9. Active GI bleeding 3 months before entry
  10. Intolerant to HCQ in the past treatment history；
  11. Severe bone marrow suppression or liver damage caused by cyclophosphamide in the past history；
  12. Active infection , including bacteria, virus, fungi, mycobacteria
  13. Allergy to any of the study medications
  14. Confirmed TTP(thrombolic thrombocytopenic purpura)or CAPS(catastrophic anti-phosphilipid syndrome)
  15. Platelet count less than 20X109/L with active bleeding
  16. Myelodysplastic diseases
  17. Patients with heart and lung function impairment
  18. thiopurine S-methyltransferase (TPMT) gene positive -
Contacts and Locations
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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): NCT02444728


Contacts
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Contact: Xinping Tian, MD 86-10-69158793 tianxp6@126.com
Contact: Mengtao Li, MD 86-10-69158793 mengtao.li@cstar.org.cn

Locations
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China, Anhui
the Affiliated Hospital to Bangbu Medical University Recruiting
Bangbu, Anhui, China, 233000
Contact: Zhijun Li, MD    13955289810    zhijun.li@cstar.org.cn   
Contact: Changhao Xie, MD    15255227208    uglboy2002@126.com   
China, Hebei
Hebei Provincial Hospital Recruiting
Shijiazhuang, Hebei, China, 050051
Contact: Fengxiao Zhang, MD    13722879168    fengxiao.zhang@cstar.org.cn   
Contact: Wei Lin, MD    17736909239    linwei272@163.com   
China, Hunan
the First Affiliated Hospital of Xiangya Medical University Recruiting
Changsha, Hunan, China, 410000
Contact: Xiaoxia Zuo, MD    86-13787216257    xiaoxia.zuo@cstar.org.cn   
Contact: jing Huang, MD    15874869645    jilianhj@csu.edu.cn   
China, Inner Mongolia
the Affiliated Hospital of Inner Mongolia Medical University Recruiting
Huhehaote, Inner Mongolia, China, 010050
Contact: Hongbin Li, MD    13948536552    hongbin.li@cstar.org.cn   
Contact: Ning Tie, MD    13948610720    tieting@126.com   
China, Jilin
Sino-Japanese Friendship Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China, 410008
Contact: Liqi Bi, MD    13578879099    liqi.bi@cstar.org.cn   
Contact: Cuili Ma, MD    13664438195    macuili@yeah.net   
China, Shanxi
the Affiliated Hospital of Xian Communication Hospital Not yet recruiting
Xian, Shanxi, China, 710000
Contact: Lan He, MD    13809156236    lan.he@cstar.org.cn   
Contact: Bomiao Ju, MD    18792778105    18792778105@163.com   
Xijing Hospital Recruiting
Xian, Shanxi, China, 710032
Contact: Ping Zhu, MD    13700235112    ping.zhu@cstar.org.cn   
Contact: Weitong Chen, MD    15771943030    chenweitong0818@163.com   
China, Xinjiang
Xinjiang Provincial Hospital Not yet recruiting
Urumqi, Xinjiang, China, 830001
Contact: Lijun Wu, MD    13999265917    lijun.wu@cstar.org.cn   
Contact: Cainan Luo, MD    15739551667    future_tense@sina.com   
China, Yunnan
the Affiliated Hospital of Kunming Medical University Recruiting
Kunming, Yunnan, China, 650032
Contact: Jian Xu, MD    13888566797    jian.xu@cstar.org.cn   
Contact: Shu Li, MD    15198785584    gglis@126.com   
China
Beijng Hospital Not yet recruiting
Beijing, China, 100006
Contact: Cibo Huang, MD    86-10-86372388    cibo.huang@cstar.org.cn   
Beijing Chaoyang Hospital Recruiting
Beijing, China, 100020
Contact: Yi Zheng, MD    13911170090    yi.zheng@cstar.org.cn   
Contact: Yongfeng Zhang, MD    13671239495    zyf760116@sina.com   
China-Japan Friendship Hospital Not yet recruiting
Beijing, China, 100029
Contact: Gaochun Wang, MD    13910729602    guochun.wang@cstar.org.cn   
Contact: Li Ma, MD    13910289103    marryma@vip.sina.com   
Peking Union Medical College Hospital Recruiting
Beijing, China, 100032
Contact: Xinping Tian, MD    86-13691165939    tianxp6@126.com   
Contact: Ai Xu, Coordinator    86-15910602883    1989xuai@sina.cn   
Sub-Investigator: Mengtao Li, MD         
Beijing Xuanwu Hospital Recruiting
Beijing, China, 100053
Contact: Xiaoxia Li, MD    13501164945    xiaoxia.li@cstar.org.cn   
Contact: Yi Zhao, MD    13811038669    zhaoyi_peking@163.com   
General Hospital of Tianjing Medical University Recruiting
Tianjin, China, 300052
Contact: Wei Wei, MD    13920182411    wei.wei@cstar.org.cn   
Contact: Na Zhang, MD    13820489562    lunazhang22@hotmail.com   
Sponsors and Collaborators
Chinese SLE Treatment And Research Group
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Xiaofeng Zeng, MD Chinese SLE Treatment And Research Group
Study Chair: Xiaofeng Zeng, MD Peking Union Medical College Hospital
Principal Investigator: Xinping Tian, MD Peking Union Medical College Hospital
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Chinese SLE Treatment And Research Group
ClinicalTrials.gov Identifier: NCT02444728    
Other Study ID Numbers: CSTAR001
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: July 2015
Keywords provided by Chinese SLE Treatment And Research Group:
thrombocytopenia
systemic lupus erythematosus
hydroxychloroquine
cyclophosphamide
remission
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Hydroxychloroquine
Methylprednisolone
Cyclophosphamide
Azathioprine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
 Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents