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Leukemia, Myeloid, Acute clinical trials

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NCT ID: NCT06211452 Completed - AML Clinical Trials

Comparison of Consolidation Strategies for Pediatric Patients With Acute Myeloid Leukemia

Start date: August 1, 2007
Phase: Phase 3
Study type: Interventional

GATLA 8-AML´07 trial is an multicenter phase III dose-optimization trial for the treatment of acute myeloid leukemias in children and adolescents. Patients are treated with a combination of intensive chemotherapy in combination with intrathecal-injection by CNS and haematopoietic stem cell transplantation. The patients are stratified in a standard-group (SR) and a high risk-group (HR). SR was defined as FAB (French-American-British) M1/M2 with Auer rods; FAB M4eo or favorable cytogenetics [t(8;21)/AML1-ETO or inv(16) or t(16;16) and/or CBFB/MYH11)]; bone marrow blasts ≤5% on day 15. HR was defined as all others. SR patients were reclassified to the HR group if FLT3-ITD positive. Based on the experience of the BFM group, it was decided to randomly evaluate whether the six-drug conventional consolidation stage can be replaced with the use of a consolidation based by block therapy on drugs of proven efficacy in AML with the aim of reducing residual disease, and the toxicity of this stage. Patients are randomized once the double induction is completed into those who will receive the conventional consolidation phase and those who will receive consolidation with the combination of high doses cytarabine and two different anthracyclines sequentially.

NCT ID: NCT06201247 Recruiting - Clinical trials for Acute Myeloid Leukemia, in Relapse

Off-the-shelf CD123 CAR-NK for R/R AML

Start date: December 30, 2023
Phase: Early Phase 1
Study type: Interventional

This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).

NCT ID: NCT06200441 Recruiting - Clinical trials for Endothelial Dysfunction

Correlation of Serum Gasdermin-D and NLRP-3 Inflammasome Levels With GVHD Biomarkers and Endothelial Damage Markers in Graft-Versus-Host Disease

Start date: November 15, 2023
Phase:
Study type: Observational [Patient Registry]

The investigators aimed to reveal the relationship between serum markers of pyroptosis, GVHD biomarkers and endothelial damage markers in patients who were planned for allogeneic stem cell transplantation for AML and developed GVHD during follow-up. Secondary outcomes of the study were to demonstrate the role of pyroptosis in the pathophysiology of GVHD and transplantation-associated endothelial injury using serum plasma samples; the efficacy of GVHD biomarkers used to demonstrate organ-specific involvement; and the efficacy of GVHD biomarkers and endothelial injury markers in predicting the development of GVHD, transplantation-associated endothelial injury and non-relapse mortality.

NCT ID: NCT06197672 Recruiting - Clinical trials for Acute Myeloid Leukemia

Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant

Start date: March 19, 2024
Phase: Phase 1
Study type: Interventional

This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-redirected chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory AML. the study will evaluate safety in this patient population and also the presence of efficacy signal described by elimination of residual disease to qualify patients for stem cell transplant.

NCT ID: NCT06195891 Recruiting - Clinical trials for Acute Myeloid Leukemia

Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome

Start date: September 28, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial tests the side effects and best dose of total marrow lymphoid irradiation along with chemotherapy, with fludarabine and melphalan, with or without thiotepa, in combination with Orca-T cells for patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS). Total marrow and lymphoid irradiation is a targeted form of total body irradiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Giving chemotherapy with medications such as thiotepa, fludarabine, and melphalan before a treatment with stem cells helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Orca-T cells take cells from a donor and remove some of the T cells and replace them with partially engineered T cells in order to induce better tolerance in patients. Giving total marrow and lymphoid irradiation and chemotherapy followed by Orca -T cells may be an effective treatment for patients with AML, ALL or MDS.

NCT ID: NCT06191978 Suspended - Clinical trials for Acute Myeloid Leukemia

A Phase Ia/Ib Open-label, Multiple Dose, Study to Determine the Recommended Dose, Evaluate PKs, PDs, Safety, and Activity of Venetoclax in Combination With Oral Decitabine/Cedazuridine (ASTX727) in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)

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

To find a recommended dose of ASTX727 (cedazuridine/decitabine) in combination with venetoclax for pediatric patients with relapsed AML.

NCT ID: NCT06191263 Recruiting - Clinical trials for Acute Myeloid Leukemia

Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML

RIVER-81
Start date: January 5, 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 when administered in combination with venetoclax to adult patients with acute myeloid leukemia (AML) who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent. The study consists of three parts. Part 1 aims to identify the doses of RVU120 and venetoclax that are considered to be safe and tolerated. Part 2 will assess the safety and efficacy of the doses selected. And Part 3 is a confirmatory cohort where patients will be treated at the same doses assessed in Part 2

NCT ID: NCT06188182 Not yet recruiting - AML, Adult Clinical Trials

D-index as a Predictor of Complication of Treatment of Patients With Acute Myeloid Leukemia

Start date: June 1, 2024
Phase:
Study type: Observational

1. The effect of D-index on the onset and severity of FN in AML patients. 2. Relationship between the c-D-index and duration of FN in AML patients. 3. Correlation between D-index and MDR. 4. Correlation between D-index and invasive fungal infection. 5. Comparison of FN in different treatment protocols for AML using D-index. 6. Prediction of pulmonary, fungal or blood stream infection.

NCT ID: NCT06182592 Not yet recruiting - Clinical trials for High-risk (Secondary) Acute Myeloid Leukemia

A Bridging Study of Liposomal Cytarabine-Daunorubicin in Treating Olderly Patients With Treatment-naive High-Risk (Secondary) Acute Myeloid Leukemia

Start date: January 2024
Phase: Phase 3
Study type: Interventional

The purpose of this bridging study is to determine the efficacy of liposomal cytarabine-daunorubicin for injection compared with cytarabine and daunorubicin in older patients with high-risk (secondary) acute myeloid leukemia.

NCT ID: NCT06181734 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC

CONFIDHENCE
Start date: December 20, 2023
Phase:
Study type: Observational

The goal of this non-interventional study is to evaluate quality of life (QoL) in adult patients with newly diagnosed IDH1 R132-mutated AML who are not eligible to receive standard induction chemotherapy and who are treated with ivosidenib in combination with azacitidine in a real-world setting in Germany. The main questions it aims to answer are: - Evaluate QoL by validated and widely used Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) questionnaire and European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire during treatment and follow-up period - Assesment of effectiveness in routine treatment (e.g. overall survival, event-free survival, overall response rate) - Assessment of drug safety (all adverse events) - Description of treatment reality in detail