Search results for "Interim"
showing 10 items of 95 documents
Does neoadjuvant FOLFOX chemotherapy improve the prognosis of high‐risk Stage II and III colon cancers? Three years' follow‐up results of the PRODIGE…
2021
International audience; Aim Neoadjuvant chemotherapy has proven valuable in locally advanced resectable colon cancer (CC) but its effect on oncological outcomes is uncertain. The aim of the present paper was to report 3-year oncological outcomes, representing the secondary endpoints of the PRODIGE 22 trial. Method PRODIGE 22 was a randomized multicentre phase II trial in high-risk T3, T4 and/or N2 CC patients on CT scan. Patients were randomized between 6 months of adjuvant FOLFOX (upfront surgery) or perioperative FOLFOX (four cycles before surgery and eight cycles after; FOLFOX perioperative). In wild-type RAS patients, a third arm testing perioperative FOLFOX-cetuximab was added. The pri…
First Interim Analysis of the Italian Dante Study: De-Escalation before Treatment-Free Remission in Patients with Chronic Myeloid Leukemia Treated wi…
2021
Abstract Introduction: Treatment-free remission (TFR) in chronic myeloid leukemia (CML) is demonstrated to be achievable and recommended for patients (pts) in sustained deep molecular response (sDMR) who can discontinue tyrosine kinase inhibitor (TKI) treatment and maintain responses in ~50% of cases. While the feasibility and safety of TKI cessation have been largely demonstrated, the strategies of TFR optimization are yet to be clarified. Studies (eg. DESTINY) investigating de-escalation, mainly after imatinib, suggested that a stepwise approach may favor TFR outcome. We present the interim results of the phase 2, prospective, multicenter DANTE study (NCT03874858) evaluating de-escalation…
Efficacy of Rituximab Combined in Salvage- and High Dose-Therapy (HDT) for Patients with Relapsed NHL; Interim Analysis of a Multicenter Phase II Stu…
2004
Abstract The introduction of Rituximab (R) in the treatment of B-NHL resulted in improvement in first line therapies for indolent (ind.) and aggressive (agg.) B-NHL. However, the value of R in intensive chemotherapy relapse strategies has not definitely been demonstrated. In a phase I/II clinical trial we have demonstrated safety of R as an in vivo purging agens in salvage and high dose therapy for relapsed/refractory B-NHL. This led, with promising response rates, to the initiation of a multicenter phase II trial to further prove therapeutic efficacy. Inclusion criteria were: Pt < 65 years, ECOG < 3, relapse or progression for patients with ind. NHL and induction failure or relapse f…
BCR-ABL Derived Peptide Vaccine in Chronic Myeloid Leukemia Patients with Molecular Minimal Residual Disease During Imatinib: Interim Analysis of a P…
2009
Abstract Abstract 648 Introduction: Imatinib (IM) 400mg daily is the standard treatment for chronic myeloid leukemia (CML) patients and a complete cytogenetic response (CCyR) is achieved in the majority of patients within one year of treatment. In addition, a considerable number of patients reach a major molecular response (i.e BCR-ABL/ABL ratio <0.1%) but BCR-ABL transcript is still measurable in most of treated patients revealing the persistence of a minimal residual disease (MRD). In a previous small pilot study, vaccinations with p210 b3a2-derived fusion peptides in IM treated CML patients appeared to induce both a peptide specific immune response and a reduction of residual disease …
Analysis of Metabolic Parameters Coming from Basal and Interim PET in Hodgkin Lymphoma
2018
Objective: Positron Emission Tomography (PET) with F-18-Fluoro-deoxy-glucose (FDG) emerged as a prognostic tool to predict treatment outcome in Hodgkin Lymphoma (HL). Moreover, a FDG-PET adapted strategy is currently assessed in clinical trial to minimize the toxic effect while maintaining the efficacy of treatment in HL. Purpose was to analyze the quantitative parameters to support the prognostic role of FDG-PET today based on the semi-quantitative Deauville 5-point Scale (D5-PS). Methods: This retrospective study included 53 patients diagnosed with advanced-stage HL between 2009 and 2014, enrolled in the PET response-adapted clinical trial HD 0607. FDG-PET was performed at baseline (PET0)…
549 An RNA-lipoplex (RNA-LPX) vaccine demonstrates strong immunogenicity and promising clinical activity in a Phase I trial in cutaneous melanoma pat…
2021
BackgroundLipo-MERIT is an ongoing, first-in-human, open-label, dose-escalation Phase I trial investigating safety, tolerability and immunogenicity of BNT111 in patients with advanced melanoma. BNT111 is an RNA-LPX vaccine targeting the melanoma tumor-associated antigens (TAAs) New York esophageal squamous cell carcinoma 1 (NY-ESO-1), tyrosinase, melanoma-associated antigen 3 (MAGE-A3), and transmembrane phosphatase with tensin homology (TPTE). A previous exploratory interim analysis showed that BNT111, alone or combined with immune checkpoint inhibition (CPI), has a favorable adverse event (AE) profile, gives rise to antigen-specific T-cell responses and induces durable objective responses…
Strategies for Including Patients Recruited During Interim Analysis of Clinical Trials
2007
In clinical trials a periodical check of safety and efficacy data is often needed. For organizational reasons it is rarely desirable to stop a trial during such an interim analysis. Therefore, new study patients are included in the trial while the interim analysis is ongoing. Disregarding the additional information provided by these interim patients would be unsatisfactory, especially for an office of regulatory affairs. Consequently, the rules for group sequential or adaptive decisions must be adjusted to the recruitment of interim patients. In this paper, two strategies for modifying study designs to consider the analysis of interim patients are proposed.
Marginal adaptation of three-unit interim restorations fabricated by the CAD-CA systems and the direct method before and after thermocycling
2020
Background Limited information is available regarding the marginal adaptation of three-unit interim restorations fabricated by different techniques from different materials. Also, the efficacy of computer-aided design/computer-aided manufacturing (CAD-CAM) systems for their fabrication is still questionable. This study aimed to assess the marginal adaptation of three-unit interim restorations fabricated by the CAD-CAM systems and the direct method from different materials before and after thermocycling. Material and Methods A sound mandibular second premolar and a second molar were prepared for a three-unit all-ceramic restoration. Metal dies were fabricated to simulate a case of mandibular…
The Speed of Incorporating Information into Prices
2013
Abstract To determine the speed of adjusting asset prices to the latest market information, investors usually resort to semi-strong form efficiency tests. Semi-strong form efficiency is based on the assumption that stock prices adjust rapidly as a result of new public information. The objective of the event study conducted in this paper was to examine whether new information is incorporated into the share price in a single price change after its public distribution. We analyzed the price behaviour of companies listed under Category I of the Bucharest Stock Exchange around events such interim result announcements between June and November 2012.
Gemcitabine and cisplatin versus vinorelbine and cisplatin versus ifosfamide+gemcitabine followed by vinorelbine and cisplatin versus vinorelbine and…
2003
Abstract Purpose: we carried out a phase III randomized trial to compare vinorelbine–cisplatin regimen to gemcitabine–cisplatin regimen, and to a sequential administration of gemcitabine–ifosfamide followed by vinorelbine–cisplatin or the opposite sequence of vinorelbine–cisplatin followed by ifosfamide–gemcitabine according to the ‘worst drug rule’ hypothesis in patients with locally advanced unresectable stage IIIB or metastatic stage IV non-small cell lung cancer. The primary endpoint was survival parameters, while secondary endpoints included analysis of response rates and toxicity. Patients and methods: patients were randomized to receive: (a) gemcitabine 1000 mg/m2 on days 1, 8 and 15…