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NCT ID: NCT04251065 Active, not recruiting - Clinical trials for Relapsed T-Cell Lymphoma

Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH

Start date: September 3, 2020
Phase: Phase 2
Study type: Interventional

FIL_Dara-GDP is a phase II, open label, multicenter clinical trial. The sponsor of this clinical trial is Fondazione Italiana Linfomi (FIL). The primary objective is to evaluate the efficacy of 4 courses of D-GDP (Daratumumab in combination with Gemcitabine, Cisplatin, Dexamethasone) in terms of complete response in patients with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of T follicular helper cells (TFH cells) origin refractory/relapsed after at least one and no more than two previous lines of therapy.

NCT ID: NCT04251039 Not yet recruiting - Coronary Disease Clinical Trials

in Patients With SCAD Undergoing Complex PCI, the RESPONSE Study"

Start date: December 2022
Phase:
Study type: Observational [Patient Registry]

Evaluation of Efficacy/Safety in Cangrelor use in patients with SCAD undergoing complex PCI. Prospective, observational, multicenter registry.

NCT ID: NCT04250922 Active, not recruiting - Clinical trials for Glioblastoma Multiforme

LAM561 With RT and TMZ for Adults With Glioblastoma

CLINGLIO
Start date: December 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The proposed Phase IIB/III randomized, double-blind, placebo-controlled trial in subjects with newly diagnosed primary glioblastoma multiforme (ndGBM) aims to compare the efficacy and safety of LAM561 versus placebo, given with standard of care (SoC) therapy of radiation therapy plus temozolomide (TMZ), followed by an adjuvant treatment of 6 month period of TMZ and then LAM561 or placebo in monotherapy.

NCT ID: NCT04250714 Completed - Atrial Fibrillation Clinical Trials

POLARx Cardiac Cryoablation System Study

POLAR ICE
Start date: August 6, 2020
Phase:
Study type: Observational

This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.

NCT ID: NCT04250246 Not yet recruiting - Melanoma Clinical Trials

A Study of NIVO Plus IPI and Guadecitabine or NIVO Plus IPI in Melanoma and NSCLC Resistant to Anti-PD1/PDL1

NIBIT-ML1
Start date: March 2020
Phase: Phase 2
Study type: Interventional

This is a run-in, randomized, non-comparative, phase II study designed according to a two stages optimal design by Simon. This phase II design will be preceded by a safety evaluation after the first cohort of 6 patients to preserve a high-grade of overlapping and/or unexpected toxicity rate. The study will assess the immune-objective response rate (iORR) (assessed using iRECIST criteria) of nivolumab combined with ipilimumab and guadecitabine or nivolumab combined with ipilimumab, in Melanoma and non-small cell lung cancer (NSCLC) patients resistant to anti-PD-1/PD-L1 therapy. Immune biologic correlates to treatment will be assessed as exploratory endpoints.

NCT ID: NCT04250155 Recruiting - Solid Tumors Clinical Trials

An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Start date: March 9, 2020
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors.

NCT ID: NCT04249362 Completed - Clinical trials for Non-small Cell Lung Cancer

Study of Durvalumab Following Radiation Therapy in Patients With Stage 3 Unresectable NSCLC Ineligible for Chemotherapy

DUART
Start date: November 26, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into 2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy [60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)]; Cohort B: palliative radiation therapy [40 to < 54 Gy or hypofractionated BED])

NCT ID: NCT04248998 Active, not recruiting - Clinical trials for Triple-negative Breast Cancer

Calorie Restriction With or Without Metformin in Triple Negative Breast Cancer

BREAKFAST
Start date: May 5, 2020
Phase: Phase 2
Study type: Interventional

Glucose starvation and metformin have synergistic antitumor effects that are mediated through the concomitant inhibition of glycolysis and mitochondrial oxidative phosphorylation. The BREAKFAST trial will evaluate the antitumor activity of combining cyclic fasting-mimicking diet (FMD), which reproduces the in vitro effects of glucose starvation, plus/minus metformin with standard preperative anthracycline-taxane chemotherapy in patients with stage I-III TNBC

NCT ID: NCT04248465 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

An Efficacy and Safety Study of Ravulizumab in ALS Participants

Start date: March 30, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.

NCT ID: NCT04247750 Recruiting - Beta-Thalassemia Clinical Trials

Testing SIROLIMUS in Beta-thalassemia Transfusion Dependent Patients (THALA-RAP)

THALA-RAP
Start date: April 13, 2021
Phase: Phase 2
Study type: Interventional

In β-thalassaemia and Sickle Cell Disease (SCD), a significant production of fetal haemoglobin (HbF) may reduce the severity of clinical course and reactivation of γ-globin gene expression in adulthood. HbF induction is one of the best strategies to ameliorate the characteristic symptoms of these diseases. Hydroxyurea (HU) is the only medication, approved by the US Food and Drug Administration, inducing HbF. However, treatments with HU induce sufficient HbF levels in only half of the patients, and side effects including leukopenia and neutropenia are frequently reported. Therefore, novel therapeutic inducers must be identified to develop a personalized treatment in β-thalassaemia and sickle cell anaemia. The availability of new treatments depends on drugs already approved for other indications, and on pharmacokinetics and pharmacovigilance already assessed. Rapamycin (as Sirolimus) is an immunosuppressant agent, approved by the FDA for acute rejection prevention in renal transplant recipients. The ability of this drug to induce γ-globin gene expression in erythroleukemia cell line and erythroid precursors cells (ErPCs) in ß-thalassaemia patients is already known. A clinical investigation on the effects of sirolimus in ß-Thalassaemia aims to evaluate several parameters related to red blood cell status and HbF levels and is a first step for the full clinical development in this new indication.