Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE (CHORUS)
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| ClinicalTrials.gov Identifier: NCT02444728 |
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Recruitment Status :
Terminated
(Because of insufficient enrollement)
First Posted : May 14, 2015
Last Update Posted : March 14, 2022
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Sponsor:
Chinese SLE Treatment And Research Group
Collaborator:
Peking Union Medical College Hospital
Information provided by (Responsible Party):
Chinese SLE Treatment And Research Group
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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 |
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 (Clinical Trial) |
| Actual Enrollment : | 50 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 |
| Actual Primary Completion Date : | December 30, 2018 |
| Actual Study Completion Date : | December 30, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Systemic lupus erythematosus
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
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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 |
Primary Outcome Measures :
- complete remission rate [ Time Frame: at 12 month ]percentage of patients whose platelet count > 100X109/L
Secondary Outcome Measures :
- 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
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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:
- Patients fulfilled the 1997 ACR modified or SLICC classification criteria of SLE；
- New onset thrombocytopenia: platelet count <30X109/L(by both routine test and citric acid anti-coagulated blood count test) within 3 months
Exclusion Criteria:
- Thrombocytopenia caused by other reasons, including drugs；
- Positive for active HAV(hepatitis A virus)/HBV(hepatitis B virus) infection
- Active HIV(human immunodeficiency virus) or HCV(hepatitis C virus) infection;
- Active HP(Helicopter pylori) infection;
- Severe liver and kidney dysfunction；
- Severe neuropsychiatric lupus；
- No response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment；
- Uncontrolled diabetes or hypertension before entry
- Active GI bleeding 3 months before entry
- Intolerant to HCQ in the past treatment history；
- Severe bone marrow suppression or liver damage caused by cyclophosphamide in the past history；
- Active infection , including bacteria, virus, fungi, mycobacteria
- Allergy to any of the study medications
- Confirmed TTP(thrombolic thrombocytopenic purpura)or CAPS(catastrophic anti-phosphilipid syndrome)
- Platelet count less than 20X109/L with active bleeding
- Myelodysplastic diseases
- Patients with heart and lung function impairment
- thiopurine S-methyltransferase (TPMT) gene positive -
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
Locations
| China, Anhui | |
| the Affiliated Hospital to Bangbu Medical University | |
| Bangbu, Anhui, China, 233000 | |
| China, Hebei | |
| Hebei Provincial Hospital | |
| Shijiazhuang, Hebei, China, 050051 | |
| China, Hunan | |
| the First Affiliated Hospital of Xiangya Medical University | |
| Changsha, Hunan, China, 410000 | |
| China, Inner Mongolia | |
| the Affiliated Hospital of Inner Mongolia Medical University | |
| Huhehaote, Inner Mongolia, China, 010050 | |
| China, Jilin | |
| Sino-Japanese Friendship Hospital of Jilin University | |
| Changchun, Jilin, China, 410008 | |
| China, Shanxi | |
| the Affiliated Hospital of Xian Communication Hospital | |
| Xian, Shanxi, China, 710000 | |
| Xijing Hospital | |
| Xian, Shanxi, China, 710032 | |
| China, Xinjiang | |
| Xinjiang Provincial Hospital | |
| Urumqi, Xinjiang, China, 830001 | |
| China, Yunnan | |
| the Affiliated Hospital of Kunming Medical University | |
| Kunming, Yunnan, China, 650032 | |
| China | |
| Beijng Hospital | |
| Beijing, China, 100006 | |
| Beijing Chaoyang Hospital | |
| Beijing, China, 100020 | |
| China-Japan Friendship Hospital | |
| Beijing, China, 100029 | |
| Peking Union Medical College Hospital | |
| Beijing, China, 100032 | |
| Beijing Xuanwu Hospital | |
| Beijing, China, 100053 | |
| General Hospital of Tianjing Medical University | |
| Tianjin, China, 300052 | |
Sponsors and Collaborators
Chinese SLE Treatment And Research Group
Peking Union Medical College Hospital
Investigators
| 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 |
Publications of Results:
Other Publications:
Other Publications:
| 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 14, 2022 |
| Last Verified: | February 2022 |
Keywords provided by Chinese SLE Treatment And Research Group:
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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 |