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ThrombocytopeniaPhase 3CHORUSNCT02444728

Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE

A Phase 3 study testing Hydroxychloroquine, Cyclophosphamide and Azathioprine in people with Thrombocytopenia, run by Chinese SLE Treatment And Research Group at 15 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Thrombocytopenia
What is being tested?
Hydroxychloroquine, Cyclophosphamide and Azathioprine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
15 sitesChina
Study dates
Jul 2015to 30 Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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；
Show all 18Show fewer
  • 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 -

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Beijng Hospital

    Beijing, 100006

  • Beijing Chaoyang Hospital

    Beijing, 100020

  • China-Japan Friendship Hospital

    Beijing, 100029

  • Peking Union Medical College Hospital

    Beijing, 100032

  • Beijing Xuanwu Hospital

    Beijing, 100053

  • the Affiliated Hospital to Bangbu Medical University

    Bengbu, Anhui, 233000

  • Sino-Japanese Friendship Hospital of Jilin University

    Changchun, Jilin, 410008

  • the First Affiliated Hospital of Xiangya Medical University

    Changsha, Hunan, 410000

  • the Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050

  • the Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Hebei Provincial Hospital

    Shijiazhuang, Hebei, 050051

  • General Hospital of Tianjing Medical University

    Tianjin, 300052

  • Xinjiang Provincial Hospital

    Ürümqi, Xinjiang, 830001

  • the Affiliated Hospital of Xian Communication Hospital

    Xian, Shanxi, 710000

  • Xijing Hospital

    Xian, Shanxi, 710032

Other trials in China

About this study

Official title: Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus

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.

Read the 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.

Keywords
thrombocytopenia, systemic lupus erythematosus, hydroxychloroquine, cyclophosphamide, remission
Medical subject headings
Thrombocytopenia, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydroxychloroquineDrug

    Also called Fenle

    Hydroxychloroquine 200 mg BID for 12 months

  • CyclophosphamideDrug

    Also called Huanlinxianan

    Cyclophosphamide 1000mg intravenous infusion every month for 6 months

  • AzathioprineDrug

    Also called liuzuopiaolin

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

  • MethylprednisoloneDrug

    Also called meizhuole

    Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months

Study groups in NCT02444728
Study groupRoleWhat they receive
Group1:HydroxychloroquineActive comparatorHydroxychloroquine: 100 mg tablets by mouth, 400mg everyday for 12 months Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months
Receives: Drug: Hydroxychloroquine; Drug: Methylprednisolone
Group 2:CyclophosphamideActive comparatorCyclophosphamide, 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
Receives: Drug: Hydroxychloroquine; Drug: Cyclophosphamide; Drug: Azathioprine; Drug: Methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complete remission rate

    percentage of patients whose platelet count > 100X109/L

    Measured: at 12 month

Secondary outcomes (1)

  1. 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

    Measured: at 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion30 Dec 2018
  4. Study completion30 Dec 2018

Why it stopped: Because of insufficient enrollement

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02444728
Sponsor's protocol ID
CSTAR001
Acronym
CHORUS
Status last verified
Feb 2022
First submitted
12 May 2015
Last updated
14 Mar 2022
Results posted
No
Data monitoring committee
No

Publications

  • Abu-Shakra M, Shoenfeld Y. Azathioprine therapy for patients with systemic lupus erythematosus. Lupus. 2001;10(3):152-3. doi: 10.1191/096120301676669495.

    PubMed 11315344

  • 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.

    PubMed 23698017

  • 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.

    PubMed 12944568

  • 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.

    PubMed 15803929

  • 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.

    PubMed 21325604

  • 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.

    PubMed 2334081

  • 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.

    PubMed 8489547

  • 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.

    PubMed 21503695

  • 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.

    PubMed 24254965

  • 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.

    PubMed 11824975

  • 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.

    PubMed 23462431

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydroxychloroquine, Cyclophosphamide and Azathioprine in people with Thrombocytopenia, run by Chinese SLE Treatment And Research Group at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Because of insufficient enrollement). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete remission rate (time frame: at 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02444728, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.

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