List of Ongoing Clinical Trials
|
EU Trial Number |
Protocol number |
Diagnoses |
Description of the study |
Chief Examiner |
Coordinator |
Recruitment |
|
PHASE 1 |
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|
EU CT 2024-510815-30-00 |
UHKT-CAR19-01, NCT05054257 |
B-ALL, B-NHL |
Clinical evaluation of the safety and efficacy of autologous CART19 lymphocytes in patients with relapsed or refractory acute B-lymphoblastic leukemia (B-ALL) or relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL). An open-label, dose-escalating phase I study. |
MUDr. Jan Vydra, Ph.D. |
Mgr. Tereza Vosáhlová
Kateřina Waldmannová |
Yes |
|
EU CT 2022-503165-30-00 |
UHKT-CAR123-01 |
CD123+/ AML, ALL, MDS-IB2, BPDCN |
Safety and efficacy of autologous CART123 lymphocytes in patients with relapsed or refractory CD123-positive hematologic malignancies. A phase I open-label, dose escalating study. |
MUDr. Jan Vydra, Ph.D. |
Mgr. Tereza Vosáhlová
Kateřina Waldmannová
|
Yes |
|
PHASE 2 |
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|
EudraCT 2017-002331-41 |
HaploMUD |
AL |
Allogeneic hematopoietic stem cell transplantation from a matched unrelated donor versus a haploidentical related donor with matched GVHD prophylaxis in patients with acute leukemia. A prospective European randomized trial. |
MUDr. Markéta Št'astná Marková, CSc. |
Kateřina Waldmannová |
No |
|
2023-504044-34-00
|
54179060CLL2032 TAILOR
|
CLL |
A multicohort study to tailor ibrutinib treatment regimens for patients with previously untreated chronic lymphocytic leukemia |
MUDr. Robert Pytlík, Ph.D. |
Bc. Michaela Kosternová |
Yes |
|
EudraCT 2019-003221-16 |
HALF |
CML |
A prospective phase II clinical trial evaluating nationwide the efficacy and safety of tyrosine kinase inhibitor withdrawal after a prior two-step dose reduction in patients with chronic myeloid leukemia in deep molecular remission. |
MUDr. Hana Klamová, CSc. |
Ing. Tomáš Melichar, DiS.
Mgr. Aneta Brunová |
No |
|
PHASE 3 |
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|
EudraCT 2019-002217-19 |
M19-708 |
AML |
A randomised, open-label, multicentre, phase 3, two-arm clinical trial evaluating venetoclax and azacitidine versus best supportive care in maintenance therapy in patients with acute myeloid leukaemia in first remission after conventional chemotherapy (VIALE-M). |
doc. MUDr. Mgr. Cyril Šálek, Ph.D. |
Ing. Tomáš Melichar, DiS. |
No |
|
EudraCT 2019-002621-30 |
M19-063 |
AML |
A randomized, open-label, phase 3 clinical trial evaluating the safety and efficacy of venetoclax in combination with azacitidine after allogeneic stem cell transplantation in patients with acute myeloid leukemia (AML) (VIALE-T). |
MUDr. Jan Vydra, Ph.D. |
Ing. Tomáš Melichar, DiS. |
No |
|
2023-505394-32 |
EFC 17757 ROCKnrol-1 |
cGVHD |
A randomized, double-blind, phase 3, two-arm, multicenter study to evaluate the efficacy and safety of belumosudil in combination with corticosteroids versus placebo in combination with corticosteroids in participants at least 12 years of age with newly diagnosed cGVHD |
doc. MUDr. Veronika Válková, CSc., veronika.valkova@uhkt.cz |
Bc. Michaela Kosternová |
Yes |
|
EudraCT 2022-000995-21 |
CABL001J12302 |
CML |
A multicenter, open-label, randomized phase 3b clinical trial of the tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. |
MUDr. Dana Srbová dana.srbova@uhkt.cz |
Mgr. Aneta Brunová |
No |
|
EU CT Number: 2022-500275-31-00 |
Sobi.BIVV001-001 |
Haemophilia A |
An open-label, multicenter, phase 3b study evaluating physical activity and joint health in previously treated patients aged ≥12 years with severe hemophilia A treated with intravenous recombinant coagulation factor VIII Fc-von Willebrand Factor-XTEN fusion protein (rFVIIIFc- VWF-XTEN; efanesoctocog alfa) for 24 months. |
MUDr. Věra Geierová vera.geierova@uhkt.cz |
Mgr. Aneta Brunová |
No |
|
EudraCT 2022-001177-31 |
EFC16521 MAYARI |
iTTP |
An open-label, single-arm, multicentre study evaluating the efficacy and safety of caplacizumab and immunosuppressive therapy without therapeutic plasma exchange in the first-line treatment of adults with immune-mediated thrombotic thrombocytopenic purpura |
MUDr. Věra Geierová vera.geierova@uhkt.cz |
Mgr. Aneta Brunová |
Yes |
|
2023-504541-31-00 |
CA056-1060 MAXILUS
|
MDS |
Phase 3b, open-label study evaluating the efficacy and safety of Luspatercept (BMS-986346/ACE-536) initiated at the maximum approved dose in LR-MDS with IPSS-R very low, low or intermediate risk in patients requiring red blood cell transfusions (MAXILUS) |
prof. MUDr. Jaroslav Čermák, CSc. |
Bc. Michaela Kosternová |
Yes |
|
EudraCT 2020-000744-55 |
M15-954 (Verona) |
MDS |
A randomized double-blind phase 3 study evaluating the safety and efficacy of venetoclax in combination with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndrome (higher-risk MDS). |
prof. MUDr. Jaroslav Čermák, CSc. |
Ing. Tomáš Melichar, DiS. |
No |
|
EudraCT 2020-000597-26 |
BO42161 Commodore |
PNH |
A randomised, unblinded, active-controlled multicentre phase 3 study evaluating the safety and efficacy of crovalimab compared with eculizumab in adult and adolescent patients with PNH currently receiving treatment with complement system inhibitors. |
prof. MUDr. Jaroslav Čermák, CSc. |
Bc. Michaela Kosternová |
No |
|
PHASE 4 |
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|
EU/1/13/839/001 EU/1/13/839/002 |
Ponderosa |
CML |
Observational study on ponatinib (Iclusig®) treatment in patients with chronic myeloid leukemia (CML) in all phases. |
MUDr. Hana Klamová, CSc. |
Mgr. Iva Černeková |
No |
|
|
Sobi.doptelet-001 ADOPT |
ITP |
An observational, multicenter study evaluating the use and efficacy of Doptelet® (avatrombopag) in adult patients with immune thrombocytopenia (ITP) |
MUDr. Jacqueline Soukup Maalouf jacqueline.maaloufova@uhkt.cz |
Ing. Tomáš Melichar, DiS. |
No |
|
|
Sobi.PEGCET-304 |
PNH |
A single-arm, multicenter, observational study to evaluate the efficacy of pegcetacoplan in real-world settings in patients with paroxysmal nocturnal hemoglobinuria (PNH) |
MUDr. Lenka Mastíková |
Ing. Anna Dobrovolná Mgr. Aneta Brunová
|
Yes |
|
PATIENT REGISTER |
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|
NTC02053480 |
AG348-C-008 |
PK deficit |
A long-term global observational study in patients with pyruvate kinase deficiency. |
prof. MUDr. Jaroslav Čermák, CSc. |
Ing. Anna Dobrovolná |
Yes |