TPO-RAs Combined With Anti-CD20 Antibody in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies

Last updated: July 1, 2024
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

2/3

Condition

Immune Thrombocytopenia (Itp)

Thrombosis

Dysfunctional Uterine Bleeding

Treatment

The best available therapy

Combined use of TPO-RAs with low-dose anti-CD20 antibody

Clinical Study ID

NCT04915482
IIT2020034
  • Ages 18-65
  • All Genders

Study Summary

This prospective, open-label, nonrandomized, multicenter clinical trial aims at comparing the efficacy and safety of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody vs. the best available therapy(BAT)in adult immune thrombocytopenia with autoantibodies failed (due to intolerance or resistance) to first-line treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patients have provided written informed consent prior to enrollment.

  • 18-65 years old.

  • Diagnosed as ITP secondary to connective tissue diseases (including but not limitedto systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis),primary ITP with positive antinuclear antibody but not up to the diagnostic criteriaof connective tissue diseases, primary Evans syndrome, Evans syndrome secondary toconnective tissue diseases, and primary ITP with positive Coomb's test but not up tothe 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 (glucocorticoidand / or intravenous immunoglobulin) in the past, failed (poor efficacy, or failureto maintain efficacy, or relapse), or had contraindications, intolerance, or refusalof first-line treatment.

  • Treatment for ITP (including but not limited to glucocorticoids, recombinant humanthrombopoietin (rTPO)) must be completed before enrollment, or the dose must bestable or in a phase of reduction within 2 weeks before enrollment.Immunosuppressants (including but not limited to azathioprine, danazol, cyclosporineA, mycophenolate mofetil) must be finished before entering the group, or the dosemust 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

Exclusion Criteria:

  • Thrombocytopenia secondary to thyroid disease.

  • Patients with any prior history of arterial or venous thrombosis, and with any ofthe following risk factors: cancer, Factor V Leiden, ATIII deficiency, andantiphospholipid syndrome.

  • Those who had received anti-CD20 monoclonal antibody within 6 months or who hadpreviously failed to respond to low-dose anti-CD20 monoclonal antibody.

  • Patients who had failed to respond to the previous use of eltrombopag 75 mg once aday, hetrombopag 7.5mg once a day or avatrombopag 40mg once a day for more than 4weeks.

  • Patients who have received splenectomy within one year or have splenectomy planwithin 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 oxaloacetictransaminase > 3×ULN), or bilirubin level > 2×ULN except patients with Evanssyndrome.

  • 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 monthbefore enrollment.

  • Any other circumstances that the investigator considers that the patient is notsuitable to participate in the trial.

Study Design

Total Participants: 94
Treatment Group(s): 2
Primary Treatment: The best available therapy
Phase: 2/3
Study Start date:
June 06, 2021
Estimated Completion Date:
February 28, 2025

Study Description

This is a prospective, open-label, nonrandomized, multicenter clinical trial aiming at comparing the efficacy and safety of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody vs. the best available therapy(BAT)in adult immune thrombocytopenia (ITP) with autoantibodies failed (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 TPO-RAs with low-dose anti-CD20 monoclonal antibody. 2. the best available therapy(BAT)other than combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody.

The current treatment strategies and possible risks of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody 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.

Connect with a study center

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.