Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

Last updated: February 26, 2022
Sponsor: Chinese SLE Treatment And Research Group
Overall Status: Terminated

Phase

3

Condition

Dysfunctional Uterine Bleeding

Thrombosis

White Cell Disorders

Treatment

N/A

Clinical Study ID

NCT02444728
CSTAR001
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 citricacid anti-coagulated blood count test) within 3 months

Exclusion

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 studyenrollment;
  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 pasthistory;
  12. Active infection , including bacteria, virus, fungi, mycobacteria
  13. Allergy to any of the study medications
  14. Confirmed TTP(thrombolic thrombocytopenic purpura)or CAPS(catastrophicanti-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 -

Study Design

Total Participants: 50
Study Start date:
July 01, 2015
Estimated Completion Date:
December 30, 2018

Study 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.

Connect with a study center

  • the Affiliated Hospital to Bangbu Medical University

    Bangbu, Anhui 233000
    China

    Site Not Available

  • Hebei Provincial Hospital

    Shijiazhuang, Hebei 050051
    China

    Site Not Available

  • the First Affiliated Hospital of Xiangya Medical University

    Changsha, Hunan 410000
    China

    Site Not Available

  • the Affiliated Hospital of Inner Mongolia Medical University

    Huhehaote, Inner Mongolia 010050
    China

    Site Not Available

  • Sino-Japanese Friendship Hospital of Jilin University

    Changchun, Jilin 410008
    China

    Site Not Available

  • Xijing Hospital

    Xian, Shanxi 710032
    China

    Site Not Available

  • the Affiliated Hospital of Xian Communication Hospital

    Xian, Shanxi 710000
    China

    Site Not Available

  • Xinjiang Provincial Hospital

    Urumqi, Xinjiang 830001
    China

    Site Not Available

  • the Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Site Not Available

  • Beijing Chaoyang Hospital

    Beijing, 100020
    China

    Site Not Available

  • Beijing Xuanwu Hospital

    Beijing, 100053
    China

    Site Not Available

  • Beijng Hospital

    Beijing, 100006
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing, 100029
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100032
    China

    Site Not Available

  • General Hospital of Tianjing Medical University

    Tianjin, 300052
    China

    Site Not Available

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