Clinical trials: De-escalation
Kidney Transplantation
A Dose Escalation Study in de Novo Renal Transplantation
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Trial name
- NCT04311632
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- ITB-Med LLC
Salmonella Infections
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
The purpose of this study is to evaluate the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid…
- Trial name
- NCT07286370
- Testing
- Low dose of iNTS-TCV, Full dose of iNTS-TCV, TYPHIBEV
- Where
- The Gambia
- Volunteers
- 537 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Locally Advanced Head and Neck Squamous Cell Carcinoma
De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC
This study is a single-arm exploratory study conducted in LAHNSCC. Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed…
- Trial name
- NCT06572514
- Testing
- immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Ruijin Hospital
High-risk NMIBC
A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC
The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316.
- Trial name
- NCT05410730
- Testing
- SHR-1501
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Vulvar Cancer Stage Ib, Vulvar Cancer Stage II
NODE (groiN ultrasOunD cancEr)
This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1)…
- Conditions
- Vulvar Cancer Stage Ib, Vulvar Cancer Stage II, Lymph Node Metastasis, Groin Node
- Trial name
- NODE (NCT06264167)
- Testing
- High-resolution bilateral groin ultrasound surveillance
- Where
- 5 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Queensland Centre for Gynaecological Cancer
Pneumonia, Urinary Tract Infections
BetaLACTA® Test for Early De-escalation of Empirical Carbapenems in Pulmonary, Urinary and Bloodstream Infections in ICU
The emergence and rapid worldwide spread of Extended- Spectrum Beta-Lactamase-producing enterobacteriaceae (ESBLE) both in hospital and community, led physicians, and notably intensivists, to prescribe more carbapenems…
- Conditions
- Pneumonia, Urinary Tract Infections, Bloodstream Infection
- Trial name
- BLUE-CarbA (NCT03147807)
- Testing
- betaLACTA® rapid diagnostic test
- Where
- France
- Volunteers
- 75 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Chronic Myeloid Leukemia in Chronic Phase
De-escalation Strategy of Tyrosine Kinase Inhibitors Before Treatment Discontinuation in Patients With Chronic Myeloid Leukemia
The goal of this clinical trial is to learn if a 1-year dose-reduction strategy with tyrosine kinase inhibitors (TKIs) - before complete discontinuation - works to improve treatment-free remission in adults with chronic-phase…
- Trial name
- DESCML (NCT07839988)
- Testing
- Halve TKIs, Withdrawal TKIs
- Where
- China
- Volunteers
- 280 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Oropharyngeal Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma
Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma
This is a phase II clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of…
- Trial name
- NCT03215719
- Testing
- Standard Radiation Treatment, Dose-Deescalated Treatment, Cisplatinum
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- NYU Langone Health
Head-and-neck Squamous Cell Carcinoma
De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas
In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with local advanced tumors (pathologic stage T3 = pT3) and or lymph node involvement (pN+) postoperative radio - or radiochemotherapy is the…
- Trial name
- DELPHI (NCT03396718)
- Testing
- De-escalation radio(chemo)therapy - Level 1, De-escalation radio(chemo)therapy - Level 2, Standard radio(chemotherapy)
- Where
- 10 sites in Germany
- Volunteers
- 304 people
- Sponsor
- Technische Universität Dresden
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Chronic Myelomonocytic Leukemia
Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders
This phase II trial studies the side effects and best dose of total-body irradiation when given together with fludarabine phosphate followed by a donor peripheral stem cell transplant in treating patients with myelodysplastic…
- Conditions
- Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndrome, Essential Thrombocythemia
- Trial name
- NCT00397813
- Testing
- Cyclosporine, Fludarabine Phosphate, Laboratory Biomarker Analysis
- Where
- 3 sites in United States
- Volunteers
- 77 people
- Sponsor
- Fred Hutchinson Cancer Center
BRAF V600 Mutation, Low-grade Glioma
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation.
- Conditions
- BRAF V600 Mutation, Low-grade Glioma, Low Grade Glioma of Brain, Recurrent Low Grade Glioma
- Trial name
- PNOC037 (NCT07110246)
- Testing
- Dabrafenib, Trametinib, Magnetic Resonance Imaging (MRI)
- Where
- 12 sites in United States
- Volunteers
- 96 people
- Sponsor
- University of California, San Francisco
Hematologic Malignancy, Febrile Neutropenia
Early Neutropenic Fever De-escalation of Antibiotics Study
This is a randomized, open label clinical trial among individuals with hematologic conditions. The trial aims to evaluate the safety and clinical outcomes of de-escalating antibiotic therapy among stable individuals diagnosed…
- Conditions
- Hematologic Malignancy, Febrile Neutropenia, Antibiotic Stewardship
- Trial name
- END (NCT06278896)
- Testing
- Cessation of antibiotics
- Volunteers
- 260 people
- Sponsor
- Brigham and Women's Hospital
Ulcerative Colitis
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over…
- Trial name
- CAPYBARA (NCT05479058)
- Testing
- Filgotinib
- Where
- 50 sites in United States, Belgium and 11 more
- Volunteers
- 22 people
- Sponsor
- Lakefront Biotherapeutics NV
Rheumatoid Arthritis
Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction
This is an international (Sweden, Finland, Norway, Denmark, Iceland and the Netherlands) trial designed to compare the safety and efficacy of active conventional therapy (ACT) and three biologic treatments in subjects with early…
- Trial name
- NCT01491815
- Testing
- Non-biological DMARD's, Cimzia, Orencia
- Where
- 30 sites in Denmark, Finland and 4 more
- Volunteers
- 812 people
- Sponsor
- Karolinska Institutet
Human Papilloma Virus, Squamous Cell Carcinoma
De-Escalation Therapy for Human Papillomavirus Negative Disease
This study is looking to see if nivolumab, an immunotherapy drug, given with carboplatin and paclitaxel (2 chemotherapy agents) during induction therapy in advanced stage HPV negative patients can significantly shrink the…
- Conditions
- Human Papilloma Virus, Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, HPV-Related Squamous Cell Carcinoma
- Trial name
- DEPEND (NCT03944915)
- Testing
- Carboplatin, Paclitaxel, Nivolumab
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Chicago
Sepsis, Heart Failure
Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients
Within clinical settings observation of hemodynamic changes (e.g. mean systemic filling pressure, cardiac output) in critically ill patients with a clinical indication for deresuscitation with intravenous diuretic therapy.
- Conditions
- Sepsis, Heart Failure, Heart Diseases, Septic Shock
- Trial name
- NCT03395951
- Testing
- Diuretics
- Where
- Netherlands
- Volunteers
- 18 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
Breast Cancer
De-Escalation of Axillary Management in Advanced Nodal Disease
This is a prospective, phase 2, single arm trial to evaluate whether Axillary Lymph Node Dissection (ALND) can be safely omitted for patients with cN2 and cN3 breast cancer who achieve a complete clinical response on exam with a…
- Trial name
- DEMAND (NCT07643584)
- Testing
- Axillary Surgery
- Volunteers
- 120 people
- Sponsor
- University of Kansas Medical Center
Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Cancer
Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
This study is a single-arm, phase I trial, up to 16 participants with resectable PDA. The study will examine the efficacy of the mutant IDH1 inhibitor ivosidenib, in conjunction with standard-of-care mFOLFIRINOX in the…
- Trial name
- NCT05209074
- Testing
- Ivosidenib, mFOLFIRINOX
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Case Comprehensive Cancer Center
Invasive Breast Cancer
Adding Preoperative Radiotherapy Based on Early Treatment Response in Breast Cancer
RAPID-NeoBC is a prospective, multicentre, response-adapted study with a randomized component for adults with operable, nonmetastatic invasive breast cancer receiving guideline-recommended neoadjuvant systemic therapy.
- Trial name
- RAPID-NeoBC (NCT07892508)
- Testing
- Response-adapted preoperative radiotherapy, Guideline-recommended neoadjuvant systemic therapy, Serial contrast-enhanced breast MRI and breast-specific gamma imaging
- Where
- 2 sites in China
- Volunteers
- 200 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Coronary Arterial Disease (CAD)
The Switching Antiplatelet-9 (SWAP-9) Study
The purpose of this study is to compare the pharmacodynamic effects of ABCD-GENE guided vs. unguided de-escalation strategies among patients on dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI).
- Trial name
- SWAP-9 (NCT06588595)
- Testing
- Prasugrel/Ticagrelor monotherapy or aspirin plus clopidogrel, Aspirin plus clopidogrel
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- University of Florida