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Complex immunomodulatory therapy for patients with immune thrombocytopenia (T-MEM)
EU CTIS ID: 2023-505788-35-00
What this study is testing
Evaluation of the effectiveness of treatment of a four-combination of evaluated medicinal products in patients with immune thrombocytopenia.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Severe bleeding (grade 2 or more according to CTCAE), which requires a more intensive approach (hospitalization, IVIG).
- 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
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Severe bleeding (grade 2 or more according to CTCAE), which requires a more intensive approach (hospitalization, IVIG).
- 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
- Vaccination in the last 28 days before the 1st administration of study treatment (visit M1D1).
- Neuropathy
- One other severe autoimmune disease (SLE, AFS, Crohn's disease, ulcerative colitis, ...) or a combination of 2 or more less severe autoimmune diseases
- Active cancer in the last 5 years
- 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 study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.