Clinical trial NCT02444728: Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE
Official title: Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Thrombocytopenia
Keywords: thrombocytopenia
systemic lupus erythematosus
hydroxychloroquine
cyclophosphamide
remission
Lead sponsor: Chinese SLE Treatment And Research Group
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
First posted: 2015-05-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 -

Primary outcomes:
measure: complete remission rate
timeFrame: at 12 month
Secondary outcomes:
measure: partial remission rate
timeFrame: at 12 month
Other outcomes:
Locations:
city: Bangbu
country: China
facility: the Affiliated Hospital to Bangbu Medical University
state: Anhui
city: Shijiazhuang
country: China
facility: Hebei Provincial Hospital
state: Hebei
city: Changsha
country: China
facility: the First Affiliated Hospital of Xiangya Medical University
state: Hunan
city: Huhehaote
country: China
facility: the Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Changchun
country: China
facility: Sino-Japanese Friendship Hospital of Jilin University
state: Jilin
city: Xian
country: China
facility: the Affiliated Hospital of Xian Communication Hospital
state: Shanxi
city: Xian
country: China
facility: Xijing Hospital
state: Shanxi
city: Urumqi
country: China
facility: Xinjiang Provincial Hospital
state: Xinjiang
city: Kunming
country: China
facility: the Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Beijing
country: China
facility: Beijng Hospital
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Xuanwu Hospital
city: Tianjin
country: China
facility: General Hospital of Tianjing Medical University
Study officials:
affiliation: Chinese SLE Treatment And Research Group
name: Xiaofeng Zeng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Xiaofeng Zeng, MD
role: STUDY_CHAIR
affiliation: Peking Union Medical College Hospital
name: Xinping Tian, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Arnal C, Piette JC, Leone J, Taillan B, Hachulla E, Roudot-Thoraval F, Papo T, Schaeffer A, Bierling P, Godeau B. Treatment of severe immune thrombocytopenia associated with systemic lupus erythematosus: 59 cases. J Rheumatol. 2002 Jan;29(1):75-83.
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