Eltrombopag Combined With Low-dose Rituximab in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies

  • STATUS
    Recruiting
  • End date
    Feb 28, 2024
  • participants needed
    94
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
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Updated on 26 May 2022
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platelet count
immunosuppressant
cyclosporine
rituximab
glucocorticoids
thrombocytopenia
danazol
sjogren's syndrome
recombinant human thrombopoietin
eltrombopag
arthritis
azathioprine
lupus
igiv
immune tolerance
mycophenolate
evans syndrome
immune globulin

Summary

This prospective, open-label, nonrandomized, multicenter clinical trial aims at comparing the efficacy and safety of combined use of eltrombopag with low-dose rituximab vs. the best available therapy（BAT）in adult immune thrombocytopenia with autoantibodies fail (due to intolerance or resistance) to first-line treatment.

Description

This is a prospective, open-label, nonrandomized, multicenter clinical trial aiming at comparing the efficacy and safety of combined use of eltrombopag with low-dose rituximab vs. the best available therapy（BAT）in adult immune thrombocytopenia (ITP) with autoantibodies fail (due to intolerance or resistance) to first-line treatment. The subjects include ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis), primary ITP with positive antinuclear antibody but not up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome.

Adult ITP patients with autoantibodies (18-65 years) will be nonrandomly divided into the following two treatment groups: 1. combined use of eltrombopag with low-dose rituximab. 2. the best available therapy（BAT）other than combined use of eltrombopag with rituximab.

The current treatment strategies and possible risks of combined use of eltrombopag with low-dose rituximab in the treatment of ITP with autoantibodies will be fully introduced to the patients by the researchers. Then the patients will be divided into one of the two groups according to the patients' will.

Details
Condition Immune Thrombocytopenia (ITP), Autoantibodies, Evan Syndrome, Connective Tissue Diseases
Treatment Combined use of eltrombopag with low-dose rituximab, The best available therapy
Clinical Study IdentifierNCT04915482
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on26 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

The patients have provided written informed consent prior to enrollment
-65 years old
Diagnosed as ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis), primary ITP with positive antinuclear antibody but not up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome
Platelet count<30 ×10^9/L at screening
Patients who have received at least one first-line treatment of ITP (glucocorticoid and / or intravenous immunoglobulin) in the past, failed (poor efficacy, or failure to maintain efficacy, or relapse), or had contraindications, intolerance, or refusal of first-line treatment
Treatment for ITP (including but not limited to glucocorticoids, recombinant human thrombopoietin (rTPO), and other TPO receptor agonists other than eltrombopag) must be completed before enrollment, or the dose must be stable or in a phase of reduction within 2 weeks before enrollment. Immunosuppressants (including but not limited to azathioprine, danazol, cyclosporine A, mycophenolate mofetil) must be finished before entering the group, or the dose must be stable or in the reduction period within 3 months before entering the group
Effective contraceptive measures will be taken during the clinical trial

Exclusion Criteria

Thrombocytopenia secondary to thyroid disease
Patients with any prior history of arterial or venous thrombosis, and with any of the following risk factors: cancer, Factor V Leiden, ATIII deficiency, and antiphospholipid syndrome
Those who had received rituximab within 6 months or who had previously failed to respond to low-dose rituximab
Patients who had failed to respond to the previous use of eltrombopag (75 mg once a day for more than 4 weeks)
Patients who have received splenectomy within one year or have splenectomy plan within one year
Patients with lupus encephalopathy or lupus nephritis
Patients with cataract
Patients with infectious fever (including but not limited to pulmonary infection) within 1 month or with active infection during screening
Existing hepatitis B virus, hepatitis C virus replication or HIV infection
Patients with agranulocytosis (ANC <1× 10^9/L), or moderate and severe anemia (HGB < 90g/L). For patients with Evans syndrome, patients with HGB< 60g/L will be excluded
Severe liver dysfunction (alanine aminotransferase or glutamic oxaloacetic transaminase > 3×ULN), or bilirubin level > 2×ULN except patients with Evans syndrome
Patients with severe cardiac or pulmonary dysfunction
Severe renal damage (creatinine clearance < 50 ml/min)
There were surgical planners during the study
History of psychiatric disorder
Pregnant or lactating women or those planning to be pregnant during the trial
Patients with a history of drug/alcohol abuse (within 2 years before the study)
Patients that have participated in other experimental researches within one month before enrollment
Any other circumstances that the investigator considers that the patient is not suitable to participate in the trial
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