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NCT ID: NCT04751877 Active, not recruiting - Multiple Myeloma Clinical Trials

Multicenter Open Label Phase 3 Study of Isatuximab Plus Lenalidomide and Dexamethasone With/Without Bortezomib in the Treatment of Newly Diagnosed Non Frail Transplant Ineligible Multiple Myeloma Elderly Patients (≥ 65; < 80 Years).

Start date: July 17, 2021
Phase: Phase 3
Study type: Interventional

Overall the issue of patients above 65-70 years of age being that it is impossible for most of them to undergo an intensive treatment like autologous stem cell transplant with little prospect of debulking effectively the bone marrow with chemotherapy, and also few possibilities to harass the bone microenvironment in the tumoral niche. If, advanced age in frail patients is predictive of an increased risk of treatment-related toxicity, there is a growing number of elderly patients in regards to transplantation, but still fit if one considers the objectives of life characterized with prolonged survival. These patients might have the same treatment as to the transplant eligible, but without the transplant procedure. The development of immunotherapy has transformed the treatment landscape of cancer, particularly in MM, increasing the treatment possibilities with possibly fewer adverse events. The therapeutic strategy and treatment options for NTE patients moved from melphalan-based induction regimens to lenalidomide-based associations, which is now the backbone of most treatment for NTE patients. Even though the latest melphalan, bortezomib and prednisone (MPV) association was considered somewhat effective it was not so well tolerated. Furthermore, MPV hardly prolonged PFS beyond 2 years. It was recently improved with the addition of Daratumumab, first in class anti CD38 Mab in the phase III ALCYONE. The association lenalidomide and dexamethasone (Rd) has significantly improved the easiness of treating the NTE population and all drugs seem to be possible to combine to Rd. In that extent, proteasome inhibitors have always been one of the most impactful family of agents in MM, and as expected Bortezomib plus Rd has become a very relevant and commonly used regimen in NTE NDMM. These groundbreaking results have favored the development of 2 randomized phase 3 studies for registration of combination of antiCD38Mab (Daratumumab (Cepheus, NCT03652064), Isatuximab (Imroz, NCT03319667) +Rd +Velcade in comparison to VRd. Both studies have used as a comparator the VRd regimen which is today one of the safest, active and popular triplet based Rd regimen, approved, and therefore the best control arm possibly for these studies. However, as much as there has been no direct head to head comparison of VRd to Dara Rd, when looking at the data from Maia it is anticipated that DRd will become a standard of care, and might challenge strongly VRd. Yet, multiple questions remain still, anticipating the change in backbone from VRd to antiCD38 +Rd becoming the new standard of care for NTE NDMM patients. The investigators have therefore planned to answer the critical question of the role of proteasome inhibitors in NTE non frail NDMM when considering anti CD38 +Rd as the backbone.

NCT ID: NCT04747041 Active, not recruiting - Cystitis Recurrent Clinical Trials

Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis

CYSTALTERNA
Start date: May 18, 2021
Phase: N/A
Study type: Interventional

Half of the women have a once-in-a-lifetime episode of cystitis. Recurrence occurs in about 20% to 30% of patients, and half of these patients will have more than 4 episodes per year, defining recurrent cystitis. The clinical assessment sometimes brings to light favourable factors; variables in pre- or post-menopause; but in the majority of cases, no explanatory cause can solve the problem and some authors refer to resignation as a classic reaction to this problem. several countries have already opted for alternative treatments (Nonsteroidal anti-inflammatory drugs, phytotherapy, diuresis treatment), especially since the pressure of antibiotic selection is at the root of the dramatic spread of bacterial resistances. There is a growing interest in the potential of complementary medicine to assist in this care. Products based on cranberries, for example, have been particularly studied and a 2012 Cochrane review concluded that there is a benefit with an estimated risk reduction of between 10 and 20%. Another "alternative" approach is the use of Chinese medicinal herbs. These herbs have been used for more than 2000 years. The implementation of phyto-aromatherapy treatment implies a global management of patients with recurrent cystitis. Initially, it involves a curative phase as soon as the first symptoms of the attack appear, thanks to a mixture of antibacterial essential oils. In a second phase, it integrates a preventive phase over several months thanks to an association of medicinal plants whose effects in this field have been proven in vitro and in vivo, allowing to rebalance a "terrain" associating anxiety, hypersensitivity to pain, a terrain willingly associated with the irritable bowel syndrome in these patients. While having few side effects, the plants will act, in the long term, at different levels: directly on the cause of the disease thanks to their antiseptic, antiadhesive and diuretic activities, but also by reducing the symptoms thanks to their anti-inflammatory, analgesic, antispasmodic and anxiolytic activities. Investigators hypothesize that patients with recurrent cystitis can be improved by a two-phase, multi-plant, phyto-aromatherapy treatment combining several plants: the treatment of attacks, by aromatherapy, and a prophylactic treatment, by phytotherapy. In the absence of any such studies published in the literature, investigators propose a non-randomised prospective monocentric interventional pilot study on 15 patients with proof of concept and feasibility.

NCT ID: NCT04745234 Active, not recruiting - Clinical trials for Cutaneous T-Cell Lymphoma Refractory

Mogamulizumab Q4week Dosing in Participants With R/R CTCL

Start date: August 16, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1.

NCT ID: NCT04744831 Active, not recruiting - Clinical trials for Advanced Colorectal Cancer

Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer

DESTINY-CRC02
Start date: March 5, 2021
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC).

NCT ID: NCT04744584 Active, not recruiting - Clinical trials for Pulmonary Hypertension

Medication Reconciliation in Pulmonary Hypertension

OPTICARE-HTP
Start date: February 15, 2021
Phase:
Study type: Observational

Pulmonary hypertension (PH) is a life threatening condition. In PH, pulmonary arterial hypertension (PAH) and chronic thrombo-embolic chronic pulmonary hypertension (CTEPH) are two rare diseases requiring specific and complex drug management. In France ,a part of these treatments ,only available in hospital pharmacies, are generally unknown from community health care professionals despite the high risk of drug-interactions and side effects. Anticipating medication errors at the begging of the disease is therefore important, and could be done through medication reconciliation.

NCT ID: NCT04742166 Active, not recruiting - Surgical Technique Clinical Trials

Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy (IPAD)

IPAD
Start date: July 7, 2021
Phase: N/A
Study type: Interventional

Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy

NCT ID: NCT04742101 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia

Start date: March 10, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S65487 with azacitidine in patients with acute myeloid leukaemia.

NCT ID: NCT04740918 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)

KATE3
Start date: June 7, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.

NCT ID: NCT04740671 Active, not recruiting - Clinical trials for Age Related Macular Degeneration

A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD

Start date: July 1, 2021
Phase: Phase 3
Study type: Interventional

This study will compare the efficacy and safety of HLX04-O administered by intravitreal injection (IVT) with ranibizumab in patients with active wAMD.

NCT ID: NCT04737785 Active, not recruiting - Infection Clinical Trials

Central Nervous System Disorders Following Hematopoietic Stem Cell Transplantation

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

All patients undergoing allogeneic or autologous HSCT at the participating centres will be observed. Once a diagnosis of CNS disorder is made, additional data will be reported for these patients. We will identify clinical and diagnostic characteristics such as cerebrospinal fluid (CSF) and neuroimaging patterns, risk factors, response to treatment (including novel antifungal agents such as isavuconazole) and outcome. In addition, risk factors for CNS disorders after allogeneic and autologous HSCT will be analyzed using a prospectively assessed matched control group. In the future, this study might be the basis for an interventional trial (e.g. using a prophylactic approach).