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NCT ID: NCT05066958 Recruiting - Clinical trials for Acute Myeloid Leukemia

Ex-vivo Primed Memory Donor Lymphocyte Infusion to Boost Anti-viral Immunity After T-cell Depleted HSCT

Start date: September 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

HSCT from an allogeneic donor is the standard therapy for high-risk hematopoietic malignancies and a wide range of severe non-malignant diseases of the blood and immune system. The possibility of performing HSCT was significantly limited by the availability of donors compatible with the MHC system. However, modern ex-vivo and in vivo technologies for depletion of T lymphocytes have made it possible to improve the outcomes of HSCT from partially compatible related (haploidentical) donors. In representative groups, it was shown that the success of HSCT from haploidentical donors is not inferior to standard procedures of HSCT from HLA-compatible unrelated donors. HSCT from haploidentical donors in children associated with the deficit of the adaptive immune response, which persists up to 6 months after HSCT and can be an increased risk of death of the patient from opportunistic infections. To solve this problem, the method of infusion of low doses of donor memory T lymphocytes was introduced. This technology is based on the possibility of adoptive transfer of memory immune response to key viral pathogens from donor to recipient. Such infusions have been shown to be safe and to accelerate the recovery of the pathogen-specific immune response. The expansion of virus-specific T lymphocytes in the recipient's body depends on exposure to the relevant antigen in vivo. Thus, in the absence of contact with the viral antigen, the adoptive transfer of memory T lymphocytes is not accompanied in vivo by the expansion of virus-specific lymphocytes and does not form a circulating pool of memory T lymphocytes, that can protect the patient from infections. Therefore the investigators assume that ex-vivo priming of donor memory lymphocytes with relevant antigens can provide optimal antigenic stimulation and may solve the problem of restoring immunological reactivity in the early stages after HSCT. Technically ex-vivo primed memory T lymphocytes will be generated by short incubation of CD45RA-depleted fraction of the graft (a product of T lymphocyte depletion) with a pool of GMP-quality peptides representing a number of key proteins of the viral pathogens. The following are proposed as targeted antigens: CMV pp65, EBV EBNA-1, EBV LMP12A, Adeno AdV5 Hexon, BKV LT, BKV VP1. An infusion of donor memory lymphocytes will be performed on the day +1 after transplantation. Parameters of the assessment will be safety and efficacy (immune response by day 60 and stability (responses by day 180).

NCT ID: NCT05065086 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence

STORM
Start date: September 2, 2021
Phase:
Study type: Observational

Retrospective observational cohort study investigating Single modality Trans Oral Robotic surgery for primary oropharyngeal cancer: exploring the impact of surgical Margins on local disease recurrence.

NCT ID: NCT05063552 Recruiting - Clinical trials for Recurrent Head and Neck Squamous Cell Carcinoma

Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers

Start date: March 13, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This phase II/III compares the standard therapy (chemotherapy plus cetuximab) versus adding bevacizumab to standard chemotherapy, versus combination of just bevacizumab and atezolizumab in treating patients with head and neck cancer that has spread to other places in the body (metastatic or advanced stage) or has come back after prior treatment (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Cisplatin and carboplatin are in a class of chemotherapy medications known as platinum-containing compounds. They work by killing, stopping, or slowing the growth of cancer cells. Docetaxel is in a class of chemotherapy medications called taxanes. It stops cancer cells from growing and dividing and may kill them. The addition of bevacizumab to standard chemotherapy or combination therapy with bevacizumab and atezolizumab may be better than standard chemotherapy plus cetuximab in treating patients with recurrent/metastatic head and neck cancers.

NCT ID: NCT05062096 Not yet recruiting - Melanoma Clinical Trials

Characterization of NK Cells Under First Line Advanced Therapy Either as Curative Therapy for Metastatic Melanoma or as Adjuvant Therapy for High-risk of Recurrence

NAKIMEL
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Cutaneous melanoma is a tumor with a serious evolution if its initial diagnosis is late. Since 2011, the treatment of advanced forms involves two therapeutic approaches : targeted therapies (BRAF and MEK inhibitors) if the tumor carries a BRAF mutation or immunotherapies (anti-PD1, anti-CTLA-4) regardless of tumor BRAF mutation status. Current data support the hypothesis that combinations of agents targeting the tumor and its environment will be required for durable responses in the majority of patients. Investigators will study the role of NK lymphocytes in tumor immunosurveillance in patients undergoing first-line innovative therapy with metastatic melanoma or at high-risk of recurrence.

NCT ID: NCT05058339 Active, not recruiting - Clinical trials for Hematopoietic and Lymphoid Cell Neoplasm

Distress Associated With Coronavirus Disease 2019 and Telehealth on Supportive Care Patients With Advanced Cancer

Start date: April 27, 2021
Phase:
Study type: Observational

This study assesses the level of distress felt by cancer patients due to the coronavirus disease 2019 (COVID-19) pandemic. Researchers also want to learn if patients prefer to receive supportive care (palliative care) in person or through telemedicine (visits by phone or video call, such as Zoom). Information from this study may help doctors better understand how COVID-19 has affected patients with advanced cancer, patients' perceptions of telehealth, and may help clinicians tailor care to patients' needs during the pandemic.

NCT ID: NCT05057247 Active, not recruiting - Clinical trials for Metastatic Head and Neck Cancer

Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC

Start date: October 14, 2021
Phase: Phase 2
Study type: Interventional

This trial that is investigating a medication called duvelisib in combination with docetaxel for the treatment of squamous cell carcinoma of the head and neck (SCCHN) that has returned or spread outside the head and neck area. The names of the study drugs involved in this study are: - Duvelisib (PI3K inhibitor) - Docetaxel chemotherapy

NCT ID: NCT05055635 Recruiting - Anal Cancer Clinical Trials

Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)

ReRad III
Start date: July 7, 2021
Phase: Phase 2
Study type: Interventional

This protocol aims to determine toxicity and efficacy of re-irradiation for patients with recurrences from anal cancers with dose-escalated pencil beam proton therapy either pre-operative for marginally resectable recurrences or as a definitive treatment strategy (un-resectable, operation declined etc.). The over-all aim is to improve local tumor control with acceptable side effects.

NCT ID: NCT05054959 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

ICONA
Start date: June 24, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence

NCT ID: NCT05053503 Recruiting - Opioid-use Disorder Clinical Trials

Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder

RESTORE
Start date: May 25, 2022
Phase: N/A
Study type: Interventional

The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.

NCT ID: NCT05052255 Recruiting - Clinical trials for Advanced Solid Tumor

RVU120 (SEL120) in Patients With Relapse/Refractory Metastatic or Advanced Solid Tumors

Start date: August 13, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/2, dose-escalation and expansion study investigating the safety, pharmacokinetics, and efficacy of RVU120 (SEL120) in patients with metastatic or advanced solid tumors progressing from previous lines of therapy.