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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · May 31, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for adults with a condition called Immune Thrombocytopenia (ITP), which is when the body mistakenly attacks its own platelets, leading to low platelet counts and potential bleeding issues. The researchers want to see how well a combination of two treatments—TPO-RAs (which help increase platelet production) and a low-dose anti-CD20 antibody (a type of medication that reduces the immune response)—works compared to the best available therapies for those who have not responded well to earlier treatments.

To participate in this trial, individuals must be between 18 and 65 years old and have been diagnosed with certain types of ITP, particularly those related to autoimmune diseases. They should also have a very low platelet count and have previously tried standard treatments without success. Participants will be closely monitored throughout the study, and they will have access to regular check-ups and care. It’s important for potential participants to know that certain health conditions or recent treatments may exclude them from joining the trial, but those who qualify may help advance our understanding of better treatments for ITP.

Gender

ALL

Eligibility criteria

• 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 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)) 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 anti-CD20 monoclonal antibody within 6 months or who had previously 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 a day, hetrombopag 7.5mg once a day or avatrombopag 40mg 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.