Melflufen is a novel peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. It has emerged as a potential new multiple myeloma treatment, particularly for late-stage forms of the disease. Here we describe the rationale and design of OCEAN (NCT03151811), a randomized, head-to-head, superiority, open-label, global, Phase III study evaluating the efficacy and safety of melflufen + dexamethasone versus pomalidomide + dexamethasone. Eligible patients with relapsed refractory multiple myeloma have received 2-4 previous treatments and are refractory to both lenalidomide and their last treatment. Patients are excluded if they have previously received pomalidomide. The primary endpoint is progression-free survival, and key secondary endpoints include overall response rate, duration of response and overall survival.

• Klíčová slova
• MM, Phase III study, RRMM, alkylating agent, melflufen, multiple myeloma, relapsed refractory multiple myeloma,
• MeSH
• chemorezistence MeSH
• dexamethason terapeutické užití   MeSH
• doba přežití bez progrese choroby MeSH
• fenylalanin analogy a deriváty   terapeutické užití   MeSH
• klinické zkoušky, fáze III jako téma MeSH
• lenalidomid škodlivé účinky   MeSH
• lidé MeSH
• melfalan analogy a deriváty   terapeutické užití   MeSH
• mnohočetný myelom farmakoterapie   patologie   MeSH
• protokoly antitumorózní kombinované chemoterapie terapeutické užití   MeSH
• randomizované kontrolované studie jako téma MeSH
• recidiva MeSH
• thalidomid analogy a deriváty   terapeutické užití   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• protokol klinické studie MeSH
• Názvy látek
• dexamethason MeSH
• fenylalanin MeSH
• lenalidomid MeSH
• melfalan MeSH
• melflufen MeSH Prohlížeč
• pomalidomide MeSH Prohlížeč
• thalidomid MeSH

MATERIAL AND METHODS: Oleogel-S10, an ointment containing betulin-rich triterpene dry extract from birch bark was tested in an open, blindly evaluated, prospective, controlled, randomized multicentre study to improve wound healing in donor sites. The primary endpoint was time to wound closure, and secondary endpoints were scar related measurements at the time of wound closure, and 3 and 12 months after wound closure (POSAS, laser speckle contrast analysis, viscoelastic analysis). RESULTS: We report the results from a single centre (Department of Burns and Reconstructive Surgery, University Hospital Brno) of this phase III clinical trial. A total of 32 patients (25 men and 7 women) were included with the mean patient age of 41.8 years (SD, ±11.66). The mean extent of patients donor sites in the study was 56.77cm2 (SD, ±20.39). Median healing time of the verum group (Oleogel-S10) was 7 days (95% Confidence Interval 7-8 days) and for controls 8 days (95% CI 7-10 days). Comparison of POSAS data from the verum group revealed significantly lower values at all three time points as compared to the controls. Perfusion of scars of the verum group reached on average of 115 perfusion units at the end of treatment; the average was 69.8 perfusion units at the 3-month follow-up and 50.2 perfusion units at the 12-month follow-up. Control sites displayed significantly higher values at all time points (122.2 perfusion units, 73.9 perfusion units, 52.2 perfusion units). Significant differences were detected in the skins viscoelastic properties, with sites treated with Oleogel-S10 displaying more favourable values. CONCLUSION: In our results, we demonstrate the significant effectiveness of Oleogel-S10 in donor sites healingKeywords: Donor site, Triterpenes, Oleogel-S10, wound closure.

• MeSH
• bříza MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• fytoterapie MeSH
• gely aplikace a dávkování   MeSH
• hojení ran účinky léků   MeSH
• klinické zkoušky, fáze III jako téma MeSH
• lidé středního věku MeSH
• lidé MeSH
• masti aplikace a dávkování   MeSH
• místo odběru štěpu fyziologie   MeSH
• organické látky aplikace a dávkování   farmakologie   terapeutické užití   MeSH
• prospektivní studie MeSH
• rány a poranění farmakoterapie   MeSH
• rostlinné extrakty terapeutické užití   MeSH
• transplantace kůže * MeSH
• triterpeny terapeutické užití   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• betulin MeSH Prohlížeč
• gely MeSH
• masti MeSH
• oleogels MeSH Prohlížeč
• organické látky MeSH
• rostlinné extrakty MeSH
• triterpeny MeSH

Interferon-based therapies, such as ropeginterferon alfa-2b have emerged as promising disease-modifying agents for myeloproliferative neoplasms (MPNs), including essential thrombocythemia (ET). Current ET treatments aim to normalize hematological parameters and reduce the thrombotic risk, but they do not modify the natural history of the disease and hence, have no impact on disease progression. Ropeginterferon alfa-2b (trade name BESREMi®), a novel, monopegylated interferon alfa-2b with an extended administration interval, has demonstrated a robust and sustained efficacy in polycythemia vera (PV) patients. Given the similarities in disease pathophysiology and treatment goals, ropeginterferon alfa-2b holds promise as a treatment option for ET. The ROP-ET trial is a prospective, multicenter, single-arm phase III study that includes patients with ET who are intolerant or resistant to, and/or are ineligible for current therapies, such as hydroxyurea (HU), anagrelide (ANA), busulfan (BUS) and pipobroman, leaving these patients with limited treatment options. The primary endpoint is a composite response of hematologic parameters and disease-related symptoms, according to modified European LeukemiaNet (ELN) criteria. Secondary endpoints include improvements in symptoms and quality of life, molecular response and the safety profile of ropeginterferon alfa-2b. Over a 3-year period the trial assesses longer term outcomes, particularly the effects on allele burden and clinical outcomes, such as disease-related symptoms, vascular events and disease progression. No prospective clinical trial data exist for ropeginterferon alfa-2b in the planned ET study population and this study will provide new findings that may contribute to advancing the treatment landscape for ET patients with limited alternatives. TRIAL REGISTRATION: EU Clinical Trials Register; EudraCT, 2023-505160-12-00; Registered on October 30, 2023.

• Klíčová slova
• Disease modification, Essential thrombocythemia (ET), Myeloproliferative neoplasms (MPNs), Phase III, ROP-ET, Ropeginterferon alfa-2b,
• MeSH
• dospělí MeSH
• esenciální trombocytemie * farmakoterapie   MeSH
• interferon alfa-2 * terapeutické užití   škodlivé účinky   MeSH
• interferon alfa * terapeutické užití   škodlivé účinky   MeSH
• klinické zkoušky, fáze III jako téma MeSH
• lidé středního věku MeSH
• lidé MeSH
• multicentrické studie jako téma MeSH
• polyethylenglykoly * terapeutické užití   škodlivé účinky   aplikace a dávkování   MeSH
• prospektivní studie MeSH
• rekombinantní proteiny * terapeutické užití   škodlivé účinky   aplikace a dávkování   MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• protokol klinické studie MeSH
• Názvy látek
• interferon alfa-2 * MeSH
• interferon alfa * MeSH
• peginterferon alfa-2b MeSH Prohlížeč
• polyethylenglykoly * MeSH
• rekombinantní proteiny * MeSH

Prevention of relapse is a major therapeutic challenge and an unmet need for patients with acute myeloid leukemia (AML). Venetoclax is a highly selective, potent, oral BCL-2 inhibitor that induces apoptosis in AML cells. When combined with azacitidine, it leads to prolonged overall survival and rapid, durable remissions in treatment-naive AML patients ineligible for intensive chemotherapy. VIALE-M is a randomized, double-blind, two-arm study to evaluate the safety and efficacy of venetoclax in combination with oral azacitidine (CC-486) as maintenance therapy in patients in complete remission with incomplete blood count recovery after intensive induction and consolidation therapies. The primary end point is relapse-free survival. Secondary outcomes include overall survival, minimal residual disease conversion and improvement in quality-of-life. Trial Registration Number: NCT04102020 (ClinicalTrials.gov).

• Klíčová slova
• BCL-2 inhibitor, CC-486 (oral azacitidine), acute myeloid leukemia, first remission, maintenance therapy, minimal residual disease conversion, phase III, relapse-free survival, venetoclax,
• MeSH
• akutní myeloidní leukemie * MeSH
• azacytidin škodlivé účinky   MeSH
• bicyklické sloučeniny heterocyklické MeSH
• buněčné dělení MeSH
• klinické zkoušky, fáze III jako téma MeSH
• lidé MeSH
• protokoly antitumorózní kombinované chemoterapie * škodlivé účinky   MeSH
• randomizované kontrolované studie jako téma MeSH
• sulfonamidy MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• Názvy látek
• azacytidin MeSH
• bicyklické sloučeniny heterocyklické MeSH
• sulfonamidy MeSH
• venetoclax MeSH Prohlížeč

BACKGROUND: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants. METHODS/DESIGN: SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants. DISCUSSION: Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.

• Klíčová slova
• Near infrared spectroscopy, Preterm, Protocol, Randomised clinical trial,
• MeSH
• blízká infračervená spektroskopie * metody   MeSH
• gestační stáří MeSH
• klinické zkoušky, fáze III jako téma MeSH
• lidé MeSH
• monitorování fyziologických funkcí * metody   MeSH
• mozková hypoxie * diagnostické zobrazování   prevence a kontrola   MeSH
• novorozenci extrémně nezralí * MeSH
• novorozenec MeSH
• oxymetrie * metody   MeSH
• pragmatické klinické studie jako téma MeSH
• velký mozek * diagnostické zobrazování   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• novorozenec MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• protokol klinické studie MeSH

BACKGROUND: Chemotherapy with lomustine is widely considered as standard treatment option for progressive glioblastoma. The value of adding radiotherapy to second-line chemotherapy is not known. METHODS: EORTC-2227-BTG (LEGATO, NCT05904119) is an investigator-initiated, pragmatic (PRECIS-2 score: 34 out of 45), randomized, multicenter phase III trial in patients with first progression of glioblastoma. A total of 411 patients will be randomized in a 1:1 ratio to lomustine (110 mg/m2 every 6 weeks) or lomustine (110 mg/m2 every 6weeks) plus radiotherapy (35 Gy in 10 fractions). Main eligibility criteria include histologic confirmation of glioblastoma, isocitrate dehydrogenase gene (IDH) wild-type per WHO 2021 classification, first progression at least 6 months after the end of prior radiotherapy, radiologically measurable disease according to RANO criteria with a maximum tumor diameter of 5 cm, and WHO performance status of 0-2. The primary efficacy endpoint is overall survival (OS) and secondary endpoints include progression-free survival, response rate, neurocognitive function, health-related quality of life, and health economic parameters. LEGATO is funded by the European Union's Horizon Europe Research program, was activated in March 2024 and will enroll patients in 43 sites in 11 countries across Europe with study completion projected in 2028. DISCUSSION: EORTC-2227-BTG (LEGATO) is a publicly funded pragmatic phase III trial designed to clarify the efficacy of adding reirradiation to chemotherapy with lomustine for the treatment of patients with first progression of glioblastoma. TRIAL REGISTRATION: ClinicalTrials.gov NCT05904119. Registered before start of inclusion, 23 May 2023.

• Klíčová slova
• Glioblastoma, LEGATO, Lomustine, Progression, Randomized controlled trial, Reirradiation,
• MeSH
• antitumorózní látky alkylující * terapeutické užití   MeSH
• časové faktory MeSH
• chemoradioterapie metody   MeSH
• doba přežití bez progrese choroby * MeSH
• glioblastom * patologie   farmakoterapie   mortalita   radioterapie   terapie   MeSH
• klinické zkoušky, fáze III jako téma MeSH
• kvalita života MeSH
• lidé MeSH
• lomustin * aplikace a dávkování   terapeutické užití   škodlivé účinky   MeSH
• multicentrické studie jako téma * MeSH
• nádory mozku * radioterapie   patologie   mortalita   terapie   MeSH
• pragmatické klinické studie jako téma MeSH
• progrese nemoci * MeSH
• randomizované kontrolované studie jako téma MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• protokol klinické studie MeSH
• Názvy látek
• antitumorózní látky alkylující * MeSH
• lomustin * MeSH

Lysosomes are the terminal end of catabolic pathways in the cell, as well as signaling centers performing important functions such as the recycling of macromolecules, organelles, and nutrient adaptation. The importance of lysosomes in human health is supported by the fact that the deficiency of most lysosomal genes causes monogenic diseases called as a group Lysosomal Storage Diseases (LSDs). A common phenotypic hallmark of LSDs is the expansion of the lysosomal compartment that can be detected by using conventional imaging methods based on immunofluorescence protocols or overexpression of tagged lysosomal proteins. These methods require the alteration of the cellular architecture (i.e., due to fixation methods), can alter the behavior of cells (i.e., by the overexpression of proteins), and require sample preparation and the accurate selection of compatible fluorescent markers in relation to the type of analysis, therefore limiting the possibility of characterizing cellular status with simplicity. Therefore, a quantitative and label-free methodology, such as Quantitative Phase Imaging through Digital Holographic (QPI-DH), for the microscopic imaging of lysosomes in health and disease conditions may represent an important advance to study and effectively diagnose the presence of lysosomal storage in human disease. Here we proof the effectiveness of the QPI-DH method in accomplishing the detection of the lysosomal compartment using mouse embryonic fibroblasts (MEFs) derived from a Mucopolysaccharidosis type III-A (MSP-IIIA) mouse model, and comparing them with wild-type (WT) MEFs. We found that it is possible to identify label-free biomarkers able to supply a first pre-screening of the two populations, thus showing that QPI-DH can be a suitable candidate to surpass fluorescent drawbacks in the detection of lysosomes dysfunction. An appropriate numerical procedure was developed for detecting and evaluate such cellular substructures from in vitro cells cultures. Results reported in this study are encouraging about the further development of the proposed QPI-DH approach for such type of investigations about LSDs.

• Klíčová slova
• digital holography, intracellular specificity, label‐free imaging, lysosomal storage diseases, lysosomes, quantitative phase imaging,
• MeSH
• fibroblasty metabolismus   patologie   MeSH
• kvantitativní fázové zobrazování MeSH
• lidé MeSH
• lyzozomální nemoci z ukládání metabolismus   patologie   genetika   diagnóza   MeSH
• lyzozomy * metabolismus   MeSH
• mukopolysacharidóza III metabolismus   patologie   genetika   MeSH
• myši MeSH
• zvířata MeSH
• Check Tag
• lidé MeSH
• myši MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

PURPOSE: The purpose was to report the effects of delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) on the number of relapses requiring intravenous (IV) steroids and multiple sclerosis (MS)-related hospitalizations using integrated data from the Phase III DEFINE and CONFIRM studies. METHODS: DEFINE and CONFIRM were randomized, double-blind, placebo-controlled, multicenter studies that evaluated the efficacy and safety of DMF over a 2-year period in patients with relapsing-remitting MS (RRMS). Patients were randomized (1:1:1) to receive oral DMF 240 mg BID or TID, placebo, or glatiramer acetate (CONFIRM only). Eligible subjects (aged 18-55 years) had an EDSS score of 0-5.0 and experienced either ≥1 relapse in the 12 months or had ≥1 gadolinium-enhanced lesion on brain MRI in the 6 weeks, before randomization. Data DEFINE and CONFIRM were pooled and analyzed using a negative binomial regression model (adjusted for study and region). Data obtained after subjects switched to an alternative MS therapy were not included in the analysis. Only relapses confirmed by the Independent Neurology Evaluation Committee were included in the analysis of relapses requiring IV steroids. FINDINGS: The study population (intention-to-treat) comprised 2301 patients who received either placebo (n = 771), DMF BID (n = 769), or DMF TID (n = 761). Baseline demographic and disease characteristics were generally well balanced among treatment groups. Throughout the 2-year studies, the total number of relapses treated with methylprednisolone was 402, 221, and 209 in the placebo, DMF BID, and DMF TID groups, respectively. A smaller proportion of patients in the DMF BID (168 of 769 [21.8%]) and DMF TID (151 of 761 [19.8%]) groups experienced ≥1 relapse requiring IV steroids compared with the placebo group (284 of 771 [36.8%]). The total number of MS-related hospitalizations over 2 years was 136, 94, and 74 in the placebo, DMF BID, and DMF TID groups. A smaller proportion of patients in the DMF BID (73 of 769 [9.5%]) and DMF TID (57 of 761 [7.5%]) groups had ≥1 MS-related hospitalization compared with the placebo group (104 of 771 [13.5%]). IMPLICATIONS: DMF is an effective and well tolerated therapy for RRMS. In addition to clinical benefits, the use of DMF may be associated with reduced patient burden and health economic savings, resulting from a decrease in resource utilization associated with relapses. ClinicalTrials.gov identifiers: NCT00420212 and NCT00451451.

• Klíčová slova
• costs, dimethyl fumarate, hospitalization, methylprednisolone, multiple sclerosis, relapse,
• MeSH
• dimethyl fumarát aplikace a dávkování   terapeutické užití   MeSH
• dospělí MeSH
• glatiramer acetát terapeutické užití   MeSH
• hospitalizace MeSH
• imunosupresiva aplikace a dávkování   terapeutické užití   MeSH
• injekce intravenózní MeSH
• klinické zkoušky, fáze III jako téma MeSH
• léky s prodlouženým účinkem MeSH
• lidé středního věku MeSH
• lidé MeSH
• magnetická rezonanční tomografie MeSH
• methylprednisolon terapeutické užití   MeSH
• randomizované kontrolované studie jako téma MeSH
• relabující-remitující roztroušená skleróza farmakoterapie   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• metaanalýza MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH
• Názvy látek
• dimethyl fumarát MeSH
• glatiramer acetát MeSH
• imunosupresiva MeSH
• léky s prodlouženým účinkem MeSH
• methylprednisolon MeSH

PURPOSE OF THE STUDY Partial knee replacement appears to be an appropriate surgical solution of unicompartmental knee joint osteoarthritis in correctly indicated cases. The purpose of our study was to evaluate the mid-term outcomes of unicondylar knee replacement using the Oxford Phase III system in the group of patients treated by the First Department of Orthopaedic Surgery, St. Anne s University Hospital Brno. MATERIAL AND METHODS The prospective study evaluated 47 patients (in 4 patients bilaterally) after the Oxford unicompartmental knee replacement performed between 2011 and 2016. The patients were evaluated using the Knee Society Score (KSS), Oxford Knee Score (OKS) and radiological examination performed at 7.3 years after surgery on average. All the patients were operated on by the same surgeon. RESULTS Based on the questionnaires and the clinical examination, the clinical and functional status was assessed, using the Knee Society Score (KSS). The mean preoperative KSS and FS values were 59.8 and 56.5, respectively. The postoperative KSS and FS values were 91.2 and 83.4. The mean preoperative value of the Oxford Knee Score (OKS) was 27.3. Postoperatively the values reached 40.7 on average. Based on the radiological examination, the lower limb correction of axis in the frontal plane was assessed. The mean axis correction was 3.1°. The mean tibial component slope measured on lateral radiograph was 82.7°. The basic analysis of X-rays did not reveal any component malposition. The implant survival rate was calculated using the Kaplan-Meier cumulative survival curve. In our group of patients, the mean survival rate of Oxford Phase III unicondylar knee replacement at 7.3 years postoperatively is 98.0%. DISCUSSION Many studies have reported excellent results of unicondylar knee replacement and a long survival rate of over 90%. Still debated, however, are the indication criteria and also the importance of the surgeon s experience and mastery of the surgical technique. CONCLUSIONS The results of the study confirm our excellent clinical experience and the survival rate of 98% at the mean follow up of 7.3 years after surgery shows great promise for quality long-term results. Overall, crucial for the success of UKR continues to be the compliance with the indication criteria for surgery. The choice of the type of implant and, last but not least, the correct surgical technique and postoperative rehabilitation programme are also important. Key words: unicompartmental knee replacement, Oxford Phase III, osteoarthritis of the knee.

• MeSH
• artróza kolenních kloubů * chirurgie   MeSH
• lidé MeSH
• prospektivní studie MeSH
• totální endoprotéza kolene * MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• anglický abstrakt MeSH
• časopisecké články MeSH

BACKGROUND: Patients with advanced/recurrent endometrial cancer have a poor prognosis and limited treatment options. Biomarkers such as tumor protein 53 (TP53) in endometrial cancer can integrate novel strategies for improved and individualized treatment that could impact patient outcomes. In an exploratory analysis of the phase III ENGOT-EN5/GOG-3055/SIENDO study of selinexor maintenance monotherapy 80 mg in advanced/recurrent endometrial cancer, a pre-specified subgroup of patients with TP53 wild type (wt) endometrial cancer showed preliminary activity at long-term follow-up with a generally manageable safety profile (median progression-free survival 27.4 months vs 5.2 months placebo, HR=0.41). PRIMARY OBJECTIVE: To evaluate the efficacy of selinexor compared with placebo as maintenance therapy in patients with advanced or recurrent TP53wt endometrial cancer. STUDY HYPOTHESIS: Selinexor administered at 60 mg weekly as maintenance therapy will show manageable safety and maintain efficacy in patients with TP53wt advanced/recurrent endometrial cancer after systemic therapy versus placebo. TRIAL DESIGN: This is a prospective, multicenter, double-blind, placebo-controlled, randomized phase III study designed to evaluate the efficacy and safety of selinexor as a maintenance therapy in patients with advanced or recurrent TP53wt endometrial cancer. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients must have histologically confirmed endometrial cancer, TP53wt confirmed by next-generation sequencing, completed at least 12 weeks of platinum-based therapy with or without immunotherapy, with confirmed partial response or complete response, and primary Stage IV disease or at first relapse. PRIMARY ENDPOINT: The primary endpoint is investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the intent-to-treat population. SAMPLE SIZE: A total of 220 patients will be enrolled. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual is expected to be completed in 2024 with presentation of results in 2025. TRIAL REGISTRATION: NCT05611931.

• Klíčová slova
• Uterine Cancer,
• MeSH
• dvojitá slepá metoda MeSH
• hydraziny * aplikace a dávkování   terapeutické užití   MeSH
• klinické zkoušky, fáze III jako téma MeSH
• lidé MeSH
• lokální recidiva nádoru * farmakoterapie   patologie   MeSH
• multicentrické studie jako téma MeSH
• nádorový supresorový protein p53 genetika   MeSH
• nádory endometria * farmakoterapie   patologie   MeSH
• randomizované kontrolované studie jako téma MeSH
• triazoly * aplikace a dávkování   MeSH
• udržovací chemoterapie metody   MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• protokol klinické studie MeSH
• Názvy látek
• hydraziny * MeSH
• nádorový supresorový protein p53 MeSH
• selinexor MeSH Prohlížeč
• TP53 protein, human MeSH Prohlížeč
• triazoly * MeSH