Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE (CHORUS)

Chinese SLE Treatment And Research Group

Status and phase: Terminated; Phase 3

Conditions: Thrombocytopenia

Treatments: Drug: Methylprednisolone; Drug: Cyclophosphamide; Drug: Hydroxychloroquine; Drug: Azathioprine

Study type: Interventional

Funder types: Other

Identifiers

NCT02444728

CSTAR001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group1:Hydroxychloroquine

Active Comparator group

Description:

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

Treatment:

Drug: Hydroxychloroquine

Drug: Methylprednisolone

Group 2:Cyclophosphamide

Active Comparator group

Description:

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

Treatment:

Drug: Azathioprine

Drug: Hydroxychloroquine

Drug: Methylprednisolone

Drug: Cyclophosphamide