Complex immunomodulatory therapy for patients with immune thrombocytopenia (T-MEM)

Fakultni Nemocnice Hradec Kralove0 sites73 target enrollmentMay 21, 2023

ConditionsImmune thrombocytopenia MedDRA version: 23.0Level: PTClassification code: 10083842Term: Immune thrombocytopenia Class: 100000004851 Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Immune thrombocytopenia
Sponsor: Fakultni Nemocnice Hradec Kralove
Enrollment: 73
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 21, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Fakultni Nemocnice Hradec Kralove

Eligibility Criteria

Inclusion Criteria

•Age \= 18 years \- 70 years, Ability to understand the nature and course of the study and sign written informed consent to participate in the study., Ability and willingness to complete study visit and commute to study center., Diagnosis of primary immune thrombocytopenia., Platelets count below 80x109/l (after termination or on corticotherapy) and fulfillment of the indication for therapy (bleeding, need for anticoagulation, constitutional symptoms, documented refractoriness when stopping corticoids, etc.)., Previous corticosteroid therapy lasting at least 14 days (pulse or continuous), after which, according to the doctor's decision, it is necessary/appropriate to continue ITP therapy., Women of childbearing potential must have a negative pregnancy test (from blood serum) and use effective methods of contraception before starting treatment., For women of childbearing potential: Willingness to prevent pregnancy and breast\-feeding during treatment and for 12 months after the last dose of rituximab, using at least one of the highly reliable methods of contraception. For men: Willingness to prevent paternity during treatment and for the next 90 days after stopping mycophenolate treatment.

Exclusion Criteria

•Severe bleeding (grade 2 or more according to CTCAE), which requires a more intensive approach (hospitalization, IVIG)., Active cancer in the last 5 years, 11\.Previous therapy: •Previous rituximab therapy in the last 12 months. •IVIG therapy or plasmapheresis in the last 28 days before the 1st study treatment administration (visit M1D1\). •TPO\-RA therapy, fostamatinib, immunosuppressants (MMF, CSA) in the last 28 days before the 1st study treatment administration (visit M1D1\). •Cytostatic therapy in the last 28 days before the 1st study treatment administration (visit M1D1\)., Participation in a clinical study involving administration of investigational medicinal product within 3 months (or 5 half\-terms, whichever is longer) prior to screening., Laboratory findings more than 1\.5 x upper limit \- ALT, AST, GMT, ALP, creatine, PT, aPTT., Uncontrolled arterial hypertension., Infectious disease in the last 14 days before starting the study treatment (visit M1D1\)., Planned surgical procedure in the next 6 months, or until visit M6\., Splenectomy in the last 3 months., The presence of another significant disease limiting therapy (liver disease, GIT disease, psychiatric disease /suicide, depression/, etc.), Contraindications to administered drugs (simultaneous use of contraindicated drugs, HIV, hepatitis, liver disease, etc.), Breastfeeding, pregnancy, trying to get pregnant, Myelodysplastic syndrome (MDS) or other abnormalities in the blood count, except for thrombocytopenia (a sternal puncture may be necessary to exclude MDS)., History of Thrombocytopenic thrombotic purpura (TTP), Hemolytic\-uremic syndrome (HUS), antiphospholipid syndrome (AFS) or acquired hemophilia, Immunodeficiency, History of anaphylaxis