List of Active Studies
|
EU Trial Number |
Protocol Number |
Diagnoses |
Study Description |
Principal Investigator |
Coordinator |
Recruitment |
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PHASE 1 |
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Eudra CT |
UHKT-CAR19-01, NCT05054257 |
B-ALL, |
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 lymphoma (B-NHL). Open-label phase I dose-escalation study. |
MUDr. Jan Vydra, Ph.D. |
Mgr. Tereza Brabencová Kateřina Waldmannová |
yes |
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|
EU CT |
UHKT-CAR123-01, NCT06765876 |
CD123+/ AML, ALL, MDS-IB2, BPDCN |
Safety and efficacy of autologous CART123 lymphocytes in patients with relapsed or refractory CD123-positive hematological malignancy. Open-label phase I dose-escalation study. |
MUDr. Jan Vydra, Ph.D. |
Mgr. Tereza Brabencová Kateřina Waldmannová |
yes |
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| EU CT 2024-517681-41 |
IM060-0001 | SLE, SSc, IIM, RA | Phase 1, multicenter, open-label study of BMS-986515, healthy donor allogeneic CD19-targeted chimeric antigen receptor (CAR) T cells, in participants with severe, refractory autoimmune diseases. Study in collaboration with the Institute of Rheumatology as the referring center. |
MUDr. Ladislav Šenolt, Ph.D. (Institute of Rheumatology) MUDr. Jan Vydra, Ph.D. (ÚHKT) |
Ing. Anna Dobrovolná Anna.Dobrovolna@uhkt.cz Bc. Michaela Kosternová Michaela.Kosternova@uhkt.cz |
yes | |||
|
PHASE 1/2 |
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|
EU CT |
AZDO486 — D7407C00001 |
CLL |
Open-label multicenter master protocol phase I/II evaluating the safety and efficacy of AZD0486 as monotherapy or in combination with other anti-cancer agents in participants with mature B-cell malignancies. |
MUDr. Robert Pytlík, Ph.D. Robert.Pytlik@uhkt.cz |
Bc. Michaela Kosternová Michaela.Kosternova@uhkt.cz |
yes | |||
| UHKT-PTC-TMI-01 | AML, MDS | Proton radiotherapy of the bone marrow (Total Marrow Irradiation) as part of the conditioning regimen prior to allogeneic hematopoietic stem cell transplantation in patients with high- risk acute myeloid leukemia or myelodysplastic syndrome. Phase I/II pilot study. |
doc. MUDr. Veronika Válková, CSc., veronika.valkova@uhkt.cz |
Mgr. Tereza Brabencová Kateřina Waldmannová |
yes | ||||
|
PHASE 2 |
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|
EudraCT |
HaploMUD |
AL |
Allogeneic hematopoietic transplantation from a matched unrelated donor versus a haploidentical related donor with identical GVHD prophylaxis in patients with acute leukemia. Prospective European randomized study. |
MUDr. Markéta Šťastná Marková, CSc. |
Kateřina Waldmannová |
no |
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|
EU CT |
54179060CLL2032 TAILOR |
CLL |
Multi-cohort study to adapt ibrutinib treatment regimens for patients with previously untreated chronic lymphocytic leukemia |
MUDr. Robert Pytlík, Ph.D. |
Bc. Michaela Kosternová |
yes |
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|
EudraCT |
HALF |
CML |
Prospective phase II clinical study evaluating at a national level the efficacy and safety of tyrosine kinase inhibitor discontinuation following 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 |
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| EU CT 2023-510150-17-00 |
CYTB323J12201 | SLE with LN |
Phase 2 adaptive, randomized, open-label, evaluator-blinded, actively controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus standard of care in patients with systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN). Clinical study in collaboration with the Institute of Rheumatology and VFN as referring centers. |
MUDr. Jakub Závada, Ph.D. (Institute of Rheumatology) MUDr. Jan Vydra, Ph.D. (ÚHKT) |
Ing. Anna Dobrovolná Mgr. Aneta Brunová |
yes | |||
| EU CT 2023-510380-34 |
CYTB323K12201 | SSc |
Multi-part, three-year, randomized, open-label, evaluator-blinded, actively controlled, multicenter phase II study evaluating the efficacy and safety of rapcabtagene autoleucel versus rituximab in participants with severe refractory diffuse cutaneous systemic sclerosis. Clinical study in collaboration with the Institute of Rheumatology as the referring center. |
prof. MUDr. Michal Tomčík, Ph.D. (Institute of Rheumatology) MUDr. Jan Vydra, Ph.D. (ÚHKT) |
Ing. Anna Dobrovolná Mgr. Aneta Brunová |
yes | |||
|
PHASE 3 |
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| EU CT 2023-503640-14 |
20190360 - Golden gate |
ALL | Randomized, controlled phase 3 study alternating blinatumomab with low-intensity chemotherapy versus standard of care for older adults with newly diagnosed Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia with a safety run-in (Golden Gate study) | doc. MUDr. Mgr. Cyril Šálek, Ph.D. cyril.salek@uhkt.cz |
Mgr. Aneta Brunová Aneta.Brunova@uhkt.cz |
yes | |||
| EU CT 2024-520154-38 |
75276617AML3001 |
AML | Randomized, double-blind, placebo-controlled phase 3 study with bleximenib, venetoclax, and azacitidine for the treatment of participants with newly diagnosed acute myeloid leukemia with KMT2AR rearrangement or NPM1 mutations who are ineligible for intensive chemotherapy. | MUDr. Jacqueline Soukupová Maaloufová Jacqueline.Maaloufova@uhkt.cz |
Ing. Tomáš Melichar, DiS. Tomas.Melichar@uhkt.cz |
yes | |||
| EU CT 2024-520154-38 |
AC220-168 |
AML |
Double-blind, randomized, placebo-controlled phase 3 study of quizartinib administered in combination with induction and consolidation chemotherapy and as maintenance therapy in adult patients with newly diagnosed FLT3-ITD negative acute myeloid leukemia. |
MUDr. Jan Válka, Ph.D. jan.valka@uhkt.cz |
Ing. Tomáš Melichar, DiS. Tomas.Melichar@uhkt.cz |
yes | |||
|
EU CT |
M19-063 |
AML |
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 |
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|
EU CT |
CABL001J12302 |
CML |
Multicenter, open-label, randomized phase 3b clinical trial of the tolerability and efficacy of oral asciminib compared to nilotinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. |
MUDr. Dana Srbová |
Mgr. Aneta Brunová |
no |
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| EU CT 2024-517131-52-00 |
BGB-11417-303 | CLL | Randomized, open-label, multicenter phase 3 study comparing the combination of Sonrotoclax and anti-CD20 antibodies with the combination of Venetoclax and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma | MUDr. Robert Pytlík, Ph.D. Robert.Pytlik@uhkt.cz |
Bc. Michaela Kosternová Michaela.Kosternova@uhkt.cz |
yes | |||
|
EU CT |
Sobi.BIVV001-001 |
Hemophilia A |
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 |
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|
EU CT |
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 |
no |
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| EU CT 2023-504724-25 |
KRT-232-115 |
MF | Randomized, double-blind phase 3 study with a substudy evaluating the safety and efficacy of Navtemadlin plus Ruxolitinib versus placebo plus Ruxolitinib in patients with myelofibrosis who have a suboptimal response to Ruxolitinib. | MUDr. Jacqueline Soukupová Maaloufová Jacqueline.Maaloufova@uhkt.cz |
Ing. Tomáš Melichar, DiS. Tomas.Melichar@uhkt.cz |
yes | |||
| EU CT 2024-517972-39 |
EFC17360 (Lumina3) | wAIHA | Multicenter, randomized, double-blind, placebo-controlled parallel-group phase 3 study with an open-label phase and long-term extension to assess the efficacy and safety of rilzabrutinib in participants with wAIHA | MUDr. Jacqueline Soukupová Maaloufová Jacqueline.Maaloufova@uhkt.cz |
Ing. Tomáš Melichar, DiS. Tomas.Melichar@uhkt.cz |
yes | |||
|
PHASE 4 |
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Sobi.PEGCET-304 |
PNH | Single-arm, multicenter observational study to evaluate the real-world efficacy of pegcetacoplan in patients with paroxysmal nocturnal hemoglobinuria (PNH) | MUDr. Lenka Mastíková lenka.mastikova@uhkt.cz |
Ing. Anna Dobrovolná |
yes | |||
|
PATIENT REGISTRY |
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|
NTC02053480 |
AG348-C-008 |
PK Deficiency |
Long-term global observational study in patients with pyruvate kinase deficiency. |
prof. MUDr. Jaroslav Čermák, CSc. |
Ing. Anna Dobrovolná |
no |
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