Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

Phase 3TerminatedNCT02444728

Chinese SLE Treatment And Research Group50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Thrombocytopenia

Interventions

HydroxychloroquineDRUG

Hydroxychloroquine 200 mg BID for 12 months

CyclophosphamideDRUG

Cyclophosphamide 1000mg intravenous infusion every month for 6 months

AzathioprineDRUG

After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 -

Locations (15)

the Affiliated Hospital to Bangbu Medical University

Bengbu, Anhui, China

Hebei Provincial Hospital

Shijiazhuang, Hebei, China

the First Affiliated Hospital of Xiangya Medical University

Outcomes

Primary Outcomes

complete remission rate

percentage of patients whose platelet count \> 100X109/L

Time frame: at 12 month

Secondary Outcomes

partial remission rate

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

Time frame: at 12 month

Data from ClinicalTrials.gov

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