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Leukemia, Myeloid clinical trials

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NCT ID: NCT06119269 Recruiting - Clinical trials for Chronic Myeloid Leukemia, Chronic Phase

Ponatinib in CML Patients in Chronic Phase

PHOENICS
Start date: August 2, 2023
Phase:
Study type: Observational

The goal of this retrospective observational study is to evaluate any possible association between plasma concentrations of ponatinib and its pharmacodynamics (efficacy/tolerability) in patients affected by chronic myeloid leukemia in chronic phase (CML-CP). In particular, the aims of the study will be: - primary aim: to investigate the relationships (if any) between plasma concentrations and activity/toxicity of ponatinib in a population of CML-CP patients enrolled in several Italian hematological centers; - secondary aim: to set up an algorithm aimed at helping physicians to improve drug dosing based on several variables (i.e., plasma drug concentrations, tolerability, molecular response to therapy). The study will enroll CML-CP patients who were exposed to ponatinib as second, third or fourth line of chemotherapy.

NCT ID: NCT06118788 Recruiting - Clinical trials for Leukemia, Myeloid, Acute

Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Start date: March 7, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-arm, single-dose dose-escalation and dose-expansion study.

NCT ID: NCT06116318 Not yet recruiting - C-KIT Mutation Clinical Trials

A Study of c-Kit Mutation as MRD in Acute Myeloid Leukemia

Start date: November 1, 2023
Phase:
Study type: Observational

C-Kit is involved in an essential pathway of disease occurrence and is closely related to the poor prognosis of patients. However, the clinical significance of c-Kit mutation as molecular MRD monitoring is still unclear. What are the differences and advantages of using c-Kit mutation as MRD in prognostic assessment compared with other MRDs (MFC or RUNX1::RUNX1T1) widely used today? Existing data suggest that patients with one positive and one negative MRD results obtained by two different techniques have a higher risk of recurrence than patients with two negative MRD results but a lower risk of recurrence than patients with two positive MRD results. Therefore, can combining multiple MRD markers, including c-Kit mutations, overcome the shortcomings of a single molecular marker as MRD monitoring? Therefore, this project intends to confirm the clinical significance of quantitative detection of c-Kit mutation as MRD in acute myeloid leukemia.

NCT ID: NCT06113289 Suspended - Clinical trials for Acute Myeloid Leukemia

A Phase 1B/2A Trial of Combination of ASTX727 With ASTX029 in Acute Myeloid Leukemia

Start date: February 8, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

To find the recommended dose of the study drugs ASTX727 and ASTX029 that can be given to patients with relapsed/refractory AML. The goal of Part 2 of the study is to learn if the dose of study drugs found in Part 1B can help to control AML.

NCT ID: NCT06110208 Recruiting - Clinical trials for Acute Myeloid Leukemia

Study to Evaluate the Safety and Preliminary Efficacy of CLL1 and CD38 Dual CAR-T in r/r AML

Start date: October 10, 2023
Phase: Early Phase 1
Study type: Interventional

This study is a single-center clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T injection in r/r AML subjects . The included population were patients with relapsed and refractory acute myeloid leukemia (r/r AML) .

NCT ID: NCT06105658 Recruiting - Clinical trials for Acute Myelocytic Leukemia

Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With AML

Start date: October 2023
Phase: Phase 2
Study type: Interventional

This study aimed to evaluate the safety and efficacy of unrelated umbilical cord blood microtransplantation in the treatment of AML patients by observing the factors related to the efficacy and adverse reactions.

NCT ID: NCT06092879 Recruiting - Clinical trials for Chronic Myeloid Leukemia

Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France

ASSURE-3
Start date: March 6, 2024
Phase:
Study type: Observational

The purpose of this study is to enhance the knowledge on asciminib treatment in a broader and real-life population by collecting additional data to characterize the treatment patterns of patients treated with asciminib, with a primary objective represented by maintenance on treatment at 12 months.

NCT ID: NCT06088888 Recruiting - Clinical trials for Chronic Myelogenous Leukemia

TGRX-678 US Phase I for Subjects With Refractory or Advanced Chronic Myelogenous Leukemia

Start date: June 15, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this single-arm, open-label, dose escalation + cohort expansion study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-678 in Chronic Myelogenous Leukemia patients who had failure with or are intolerant to TKI treatments.

NCT ID: NCT06084819 Recruiting - Clinical trials for Relapsed/Refractory Acute Myeloid Leukemia

Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid leukemia.

NCT ID: NCT06082804 Recruiting - Clinical trials for Chronic Myelogenous Leukemia - Chronic Phase

Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia

IPA-LMC
Start date: November 29, 2023
Phase: N/A
Study type: Interventional

Chronic Myeloid Leukemia (CML) affects 820 people per year in France (2018), half of them are older than 60 years old. Tyrosine Kinase Inhibitors (TKI) are new kind of targeted therapy whose efficiency allow for a high rate of complete molecular response, leading to a disruption of treatment under certain conditions. Optimizing CML treatment is a major concern, particularly for adverse events management, treatment compliance and therapeutic response. Multiple studies demonstrated that grade ≤ II adverse events are most likely to be under reported by patients and clinicians. Although these adverse events are mostly reported by clinical examination, needing minimal treatment. These toxicities could alter daily and domestic living activities, potentially impacting treatment compliance and therapeutic response. Therefore, early detection of these adverse events is a major challenge for the prognosis and care of CML. The Advanced Practice Nurse (APN), a new health care professional, acquired the skills needed to independently follow, manage and care the patients with medical approvals. At international level, many studies, in oncology and in others domains, have been done to demonstrate the added value of the APN, particularly in improving patient's quality of life, management, care of drug-induced adverse events and treatment compliance. In France, because of the recentness of the profession, only few studies were have been conducted. The goal of this study is to demonstrate the benefit of APN in clinical follow-up, quality of life, treatment compliance, and therapeutic response of CML patients. These effects could be managed thanks to early detection and management of ≤ grade II adverse events during consultation, in partnership with the patients, and in collaborative working.