Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE
- Conditions
- Thrombocytopenia
- Interventions
- Registration Number
- NCT02444728
- Lead Sponsor
- Chinese SLE Treatment And Research Group
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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 -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2:Cyclophosphamide 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 Group 2:Cyclophosphamide Azathioprine 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 Group1:Hydroxychloroquine 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 Group 2:Cyclophosphamide Hydroxychloroquine 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 Group 2:Cyclophosphamide Methylprednisolone 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 Group1:Hydroxychloroquine Methylprednisolone 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
- Primary Outcome Measures
Name Time Method complete remission rate at 12 month percentage of patients whose platelet count \> 100X109/L
- Secondary Outcome Measures
Name Time Method partial remission rate 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
Trial Locations
- Locations (15)
Beijng Hospital
🇨🇳Beijing, China
the Affiliated Hospital to Bangbu Medical University
🇨🇳Bangbu, Anhui, China
Hebei Provincial Hospital
🇨🇳Shijiazhuang, Hebei, China
the First Affiliated Hospital of Xiangya Medical University
🇨🇳Changsha, Hunan, China
the Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Huhehaote, Inner Mongolia, China
Sino-Japanese Friendship Hospital of Jilin University
🇨🇳Changchun, Jilin, China
the Affiliated Hospital of Xian Communication Hospital
🇨🇳Xian, Shanxi, China
the Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Beijing Chaoyang Hospital
🇨🇳Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
General Hospital of Tianjing Medical University
🇨🇳Tianjin, China
Beijing Xuanwu Hospital
🇨🇳Beijing, China
Xinjiang Provincial Hospital
🇨🇳Urumqi, Xinjiang, China
Xijing Hospital
🇨🇳Xian, Shanxi, China