Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE (CHORUS)

February 26, 2022 updated by: Chinese SLE Treatment And Research Group

Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

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
      • Beijing, China, 100029
        • China-Japan Friendship Hospital
      • Beijing, China, 100032
        • Peking Union Medical College Hospital
      • Beijing, China, 100020
        • Beijing ChaoYang Hospital
      • Beijing, China, 100053
        • Beijing Xuanwu Hospital
      • Beijing, China, 100006
        • Beijng Hospital
      • Tianjin, China, 300052
        • General Hospital of Tianjing Medical University
    • Anhui
      • Bangbu, Anhui, China, 233000
        • the Affiliated Hospital to Bangbu Medical University
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Hebei Provincial Hospital
    • Hunan
      • Changsha, Hunan, China, 410000
        • the First Affiliated Hospital of Xiangya Medical University
    • Inner Mongolia
      • Huhehaote, Inner Mongolia, China, 010050
        • The Affiliated Hospital of Inner Mongolia Medical University
    • Jilin
      • Changchun, Jilin, China, 410008
        • Sino-Japanese Friendship Hospital Of Jilin University
    • Shanxi
      • Xian, Shanxi, China, 710032
        • Xijing Hospital
      • Xian, Shanxi, China, 710000
        • the Affiliated Hospital of Xian Communication Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China, 830001
        • Xinjiang Provincial Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • the Affiliated Hospital of Kunming Medical 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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Fenle
Drug: Methylprednisolone
Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months
Other Names:
  • 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 Names:
  • Fenle
Drug: Methylprednisolone
Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months
Other Names:
  • meizhuole
Drug: Cyclophosphamide
Cyclophosphamide 1000mg intravenous infusion every month for 6 months
Other Names:
  • Huanlinxianan
Drug: Azathioprine
After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months
Other Names:
  • liuzuopiaolin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete remission rate
Time Frame: at 12 month
percentage of patients whose platelet count > 100X109/L
at 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 12 month

Collaborators and Investigators

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

Sponsor

Chinese SLE Treatment And Research Group

Collaborators

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Xinping Tian, MD, Peking Union Medical College Hospital
  • Principal Investigator: Xiaofeng Zeng, MD, Chinese SLE Treatment And Research Group
  • Study Chair: Xiaofeng Zeng, MD, Peking Union Medical College Hospital

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.

General Publications

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

July 1, 2015

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

February 26, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSTAR001

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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