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Leukemia, Myeloid clinical trials

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NCT ID: NCT06220162 Recruiting - Clinical trials for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

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

Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.

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: 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: NCT06177067 Recruiting - Clinical trials for Refractory Acute Myeloid Leukemia

Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

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

This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory) or has come back after treatment (relapsed), and to determine the total dose of the 3-drug combination of revumenib, azacitidine and venetoclax that can be given safely in participants also taking an anti-fungal drug. Primary Objective - To determine the safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL. Secondary Objectives - Describe the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and overall survival for patients treated with revumenib + azacitidine + venetoclax at the recommended phase 2 dose (RP2D).

NCT ID: NCT06158828 Recruiting - Clinical trials for Acute Myeloid Leukemia

Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML

ABCD-NK
Start date: May 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II pilot study aims to enhance the effectiveness of stem cell transplant for children and young adults with high-risk acute myeloid leukemia (AML). Patients will undergo a stem cell transplant from a half-matched family donor. One week later, patients will receive an additional infusion of immune cells and a drug called interleukin-2. To mitigate the potential complications associated with graft-versus-host-disease, the donated stem cell product undergoes a process that removes a specific type of immune cell. After transplant, recipients are administered additional immune cells known as memory-like natural killer (ML NK) cells. These cells are derived by converting conventional natural killer cells obtained from the donor. The infusion of a modified stem cell product, along with administration of ML NK cells may help prevent the development of GvHD while simultaneously improving the efficacy of the treatment.

NCT ID: NCT06150040 Recruiting - Clinical trials for Acute Myeloid Leukemia Refractory

Acute Myeloid Leukemia Treated With With NETrin Abs in Combination With [AZACITIDINE + VENETOCLAX]

AML-NET
Start date: December 4, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to investigate the safety and the clinical activities of NP137 when combined with Azacitidine and Venetoclax in patients with refractory acute myeloid leukemia after 2 cycles of Azacitidine and Venetoclax.

NCT ID: NCT06146257 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes

Start date: January 11, 2024
Phase: Phase 1
Study type: Interventional

Study GLB-001-01 is a first-in-human (FIH), Phase 1, open-label, dose escalation and expansion clinical study of GLB-001 in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The dose escalation part (Phase 1a) of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 administered orally. Approximately 24 participants (up to 42 participants) may be enrolled in Phase 1a of the study. The dose expansion part (Phase 1b) will be followed to understand the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Up to 24 participants (12 participants per dose level) may be enrolled in Phase 1b of the study.