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Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE (CHORUS)

Primary Purpose

Thrombocytopenia

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Hydroxychloroquine
Cyclophosphamide
Azathioprine
Methylprednisolone
Sponsored by
Chinese SLE Treatment And Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopenia focused on measuring thrombocytopenia, systemic lupus erythematosus, hydroxychloroquine, cyclophosphamide, remission

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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 -

Sites / Locations

  • the Affiliated Hospital to Bangbu Medical University
  • Hebei Provincial Hospital
  • the First Affiliated Hospital of Xiangya Medical University
  • the Affiliated Hospital of Inner Mongolia Medical University
  • Sino-Japanese Friendship Hospital of Jilin University
  • the Affiliated Hospital of Xian Communication Hospital
  • Xijing Hospital
  • Xinjiang Provincial Hospital
  • the Affiliated Hospital of Kunming Medical University
  • Beijng Hospital
  • Beijing Chaoyang Hospital
  • China-Japan Friendship Hospital
  • Peking Union Medical College Hospital
  • Beijing Xuanwu Hospital
  • General Hospital of Tianjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group1:Hydroxychloroquine

Group 2:Cyclophosphamide

Arm 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

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

Outcomes

Primary Outcome Measures

complete remission rate
percentage of patients whose platelet count > 100X109/L

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2015
Last Updated
February 26, 2022
Sponsor
Chinese SLE Treatment And Research Group
Collaborators
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02444728
Brief Title
Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE
Acronym
CHORUS
Official Title
Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Because of insufficient enrollement
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinese SLE Treatment And Research Group
Collaborators
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
Keywords
thrombocytopenia, systemic lupus erythematosus, hydroxychloroquine, cyclophosphamide, remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group1:Hydroxychloroquine
Arm Type
Active Comparator
Arm 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
Arm Title
Group 2:Cyclophosphamide
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Fenle
Intervention Description
Hydroxychloroquine 200 mg BID for 12 months
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Huanlinxianan
Intervention Description
Cyclophosphamide 1000mg intravenous infusion every month for 6 months
Intervention Type
Drug
Intervention Name(s)
Azathioprine
Other Intervention Name(s)
liuzuopiaolin
Intervention Description
After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
meizhuole
Intervention Description
Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months
Primary Outcome Measure Information:
Title
complete remission rate
Description
percentage of patients whose platelet count > 100X109/L
Time Frame
at 12 month
Secondary Outcome Measure Information:
Title
partial remission rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng, MD
Organizational Affiliation
Chinese SLE Treatment And Research Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xinping Tian, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Affiliated Hospital to Bangbu Medical University
City
Bangbu
State/Province
Anhui
ZIP/Postal Code
233000
Country
China
Facility Name
Hebei Provincial Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
the First Affiliated Hospital of Xiangya Medical University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
the Affiliated Hospital of Inner Mongolia Medical University
City
Huhehaote
State/Province
Inner Mongolia
ZIP/Postal Code
010050
Country
China
Facility Name
Sino-Japanese Friendship Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
410008
Country
China
Facility Name
the Affiliated Hospital of Xian Communication Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Xijing Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Xinjiang Provincial Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Facility Name
the Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
Beijng Hospital
City
Beijing
ZIP/Postal Code
100006
Country
China
Facility Name
Beijing Chaoyang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Beijing Xuanwu Hospital
City
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
General Hospital of Tianjing Medical University
City
Tianjin
ZIP/Postal Code
300052
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
11315344
Citation
Abu-Shakra M, Shoenfeld Y. Azathioprine therapy for patients with systemic lupus erythematosus. Lupus. 2001;10(3):152-3. doi: 10.1191/096120301676669495.
Results Reference
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PubMed Identifier
23698017
Citation
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.
Results Reference
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PubMed Identifier
12944568
Citation
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.
Results Reference
background
PubMed Identifier
15803929
Citation
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.
Results Reference
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PubMed Identifier
21325604
Citation
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.
Results Reference
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PubMed Identifier
2334081
Citation
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.
Results Reference
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PubMed Identifier
8489547
Citation
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.
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PubMed Identifier
21503695
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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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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Citation
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Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

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