Maintenance treatment With rituximab in ITP

Phase 1

• Conditions: Immune thrombocytopenia; MedDRA version: 23.0Level: LLTClassification code 10021245Term: Idiopathic thrombocytopenic purpuraSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-005276-14-DK
• Lead Sponsor: Sykehuset Østfold HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-19
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

First randomization (Induction phase)
1. Male or female aged =18 years.
2. Diagnosis of primary ITP of less than one-year duration and having a platelet count of = 30 x109/L measured within 4 weeks prior to inclusion with failure to achieve response or relapse after one or more cycles of dexamethasone (40 mg daily for 4 days) or after at least 3 weeks under any other steroid (prednisone or prednisolone). Platelet count between 31 to 50 x109/L is accepted if higher platelet count is required due to concomitant antiplatelet therapy or bleeding.
3. Scheduled intravenous treatment of rituximab.
4. Rituximab infusion will be more than 2 weeks after the first injection of an anti-COVID-19 vaccine.
5. Signed and dated written informed consent.
6. Females of child-bearing potential accepting to follow effective contraceptive methods for at least 12 months following the last administration of rituximab or placebo.
Second randomization (maintenance phase)
7. Completion of the induction phase (phase 1) of the study.
8. Sustained response at the end of phase 1.
9. Randomization within:
a. 4 weeks after the completion of phase 1, i.e. between week 24 and 28 for a patient who can’t be vaccinated or is already vaccinated against COVID-19 or,
b. 16 weeks after the completion of phase 1 if needed to allow the patient to receive anti-COVID-19 vaccine (see Section 10.4.5.2. for vaccination recommendations).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

First randomization (Induction phase)
1. Previous treatment for ITP with: rituximab, other immune suppressants (including mycophenolate mofetil, azathioprin, cyclosporine), dapsone, danazol, thrombopoietin receptor agonist, chemotherapy or splenectomy.
2. Anti-COVID-19 unvaccinated patient with at least one of the following characteristics:
a. =65 years old
b. Obesity
c. Diagnosed Arterial hypertension
d. Diagnosed Diabetes mellitus
e. Known Kidney disease
f. Known Lung disease
3. Pregnancy or lactation.
4. Known active gastro-duodenal ulcer.
5. Secondary ITP: ITP associated with lymphoma, chronic lymphocytic leukemia, drug induced or ITP secondary to autoimmune disorders such as Systemic Lupus Erythematosis, Rheumatoid arthritis or Antiphospholipid syndrome, common variable immune deficiency, human immunodeficiency virus, hepatitis C or thrombocytopenia associated with myeloid dysplasia.
6. Concomitant autoimmune hemolytic anemia.
7. History of any major cardiovascular event within the 6 months prior to randomization, including but not limited to: myocardial infarction, unstable angina, cerebrovascular accident, or New York Heart Association Class III or IV heart failure.
8. Active hepatitis B virus or patients with positive HBsAG or HBcAB.
9. Patients with active severe infection, including systemic mycotic infections or a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection.
10. Known allergy and/or sensitivity or contraindication to rituximab or dexamethasone or any of the ingredients.
11. Patients in a severely immune compromised state.
12. Known contraindication to a treatment with any proton-pump inhibitor.
13. Active malignancy or history of malignant disease during the last 2 years
14. Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
Second randomization (maintenance phase)
1. Severe allergic reaction or serum sickness due to rituximab in phase 1 of the study.
2. Pregnancy.
3. Treatment with rescue medication after week 18.
4. Patients refusing to continue in the study (withdrawal of consent).
5. Splenectomy performed for any cause.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified