Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE
NCT ID: NCT02444728
Last Updated: 2022-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
50 participants
INTERVENTIONAL
2015-07-31
2018-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Hydroxychloroquine
Hydroxychloroquine 200 mg BID for 12 months
Methylprednisolone
Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months
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
Hydroxychloroquine
Hydroxychloroquine 200 mg BID for 12 months
Cyclophosphamide
Cyclophosphamide 1000mg intravenous infusion every month for 6 months
Azathioprine
After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months
Methylprednisolone
Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months
Interventions
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Hydroxychloroquine
Hydroxychloroquine 200 mg BID for 12 months
Cyclophosphamide
Cyclophosphamide 1000mg intravenous infusion every month for 6 months
Azathioprine
After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months
Methylprednisolone
Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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 -
18 Years
70 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Chinese SLE Treatment And Research Group
OTHER
Responsible Party
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Principal Investigators
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Xiaofeng Zeng, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese SLE Treatment And Research Group
Xiaofeng Zeng, MD
Role: STUDY_CHAIR
Peking Union Medical College Hospital
Xinping Tian, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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the Affiliated Hospital to Bangbu Medical University
Bengbu, 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
Hohhot, Inner Mongolia, China
Sino-Japanese Friendship Hospital of Jilin University
Changchun, Jilin, China
the Affiliated Hospital of Xian Communication Hospital
Xian, Shanxi, China
Xijing Hospital
Xian, Shanxi, China
Xinjiang Provincial Hospital
Ürümqi, Xinjiang, China
the Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Beijng Hospital
Beijing, , China
Beijing Chaoyang Hospital
Beijing, , China
China-Japan Friendship Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Beijing Xuanwu Hospital
Beijing, , China
General Hospital of Tianjing Medical University
Tianjin, , China
Countries
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References
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Abu-Shakra M, Shoenfeld Y. Azathioprine therapy for patients with systemic lupus erythematosus. Lupus. 2001;10(3):152-3. doi: 10.1191/096120301676669495.
Blasco LM. Hydroxychloroquine alone for severe immune thrombocytopenic purpura associated with systemic lupus erythematosus. Lupus. 2013 Jun;22(7):752-3. doi: 10.1177/0961203313490239. Epub 2013 May 22. No abstract available.
Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. doi: 10.1056/NEJMoa030254.
Contreras G, Tozman E, Nahar N, Metz D. Maintenance therapies for proliferative lupus nephritis: mycophenolate mofetil, azathioprine and intravenous cyclophosphamide. Lupus. 2005;14 Suppl 1:s33-8. doi: 10.1191/0961203305lu2115oa.
Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA; American Society of Hematology. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011 Apr 21;117(16):4190-207. doi: 10.1182/blood-2010-08-302984. Epub 2011 Feb 16.
Boumpas DT, Barez S, Klippel JH, Balow JE. Intermittent cyclophosphamide for the treatment of autoimmune thrombocytopenia in systemic lupus erythematosus. Ann Intern Med. 1990 May 1;112(9):674-7. doi: 10.7326/0003-4819-112-9-674.
Roach BA, Hutchinson GJ. Treatment of refractory, systemic lupus erythematosus-associated thrombocytopenia with intermittent low-dose intravenous cyclophosphamide. Arthritis Rheum. 1993 May;36(5):682-4. doi: 10.1002/art.1780360516.
Levine AB, Erkan D. Clinical assessment and management of cytopenias in lupus patients. Curr Rheumatol Rep. 2011 Aug;13(4):291-9. doi: 10.1007/s11926-011-0179-5.
Khellaf M, Chabrol A, Mahevas M, Roudot-Thoraval F, Limal N, Languille L, Bierling P, Michel M, Godeau B. Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies. Am J Hematol. 2014 Feb;89(2):194-8. doi: 10.1002/ajh.23609. Epub 2013 Nov 20.
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.
Newman K, Owlia MB, El-Hemaidi I, Akhtari M. Management of immune cytopenias in patients with systemic lupus erythematosus - Old and new. Autoimmun Rev. 2013 May;12(7):784-91. doi: 10.1016/j.autrev.2013.02.001. Epub 2013 Feb 24.
Other Identifiers
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CSTAR001
Identifier Type: -
Identifier Source: org_study_id
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