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Leukemia, Myeloid, Acute clinical trials

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NCT ID: NCT06180863 Withdrawn - Clinical trials for Acute Myeloid Leukemia

Oral Azacitidine (CC-486) Epigenetic Priming and Maintenance for Adult Acute Myeloid Leukemia (AML) Patients

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

To investigate the feasibility of delivering oral azacitidine (CC-486) as a consolidation regimen from the time of first complete remission (CR1), in patients with acute myelogenous leukemia (AML) eligible for curative intent Allogeneic Stem Cell Transplant (ASCT).

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: NCT06175923 Not yet recruiting - Clinical trials for Myelodysplastic Syndromes

Role of BMP Pathway in MDS Progression

BMP-MDS
Start date: January 27, 2024
Phase:
Study type: Observational

Myelodysplastic syndromes (MDS) are hematological cancers that can progress to acute myelogenous leukemia (AML). The involvement of the microenvironment in the maintenance, resistance and evolution of MDS is increasingly described. The Bone Morphogenetic Protein (BMP) pathway is involved in numerous functions, including self-renewal of the hematopoietic stem cell compartment and the regulation of hematopoiesis, via interaction with bone marrow stromal cells. Investigators have demonstrated its involvement in chronic myeloid leukemia (CML) and AML, in particular via the activation of TWIST1, ΔNp73, NANOG; it is responsible for an increased state of quiescence of certain cancer stem cells and their resistance. Preliminary results based on the analysis of large databases suggest that the BMP pathway is also altered early in MDS. This study explores the alteration of this pathway in MDS and its involvement in the transformation into AML. If appropriate, the BMP pathway could constitute a very promising therapeutic target to combat transformation into AML.

NCT ID: NCT06162325 Enrolling by invitation - Clinical trials for Acute Myeloid Leukemia

Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young AML Patients

Start date: January 21, 2022
Phase:
Study type: Observational

The goal of this observational study is to to evaluate the efficacy and safety of Venetoclax in combination with DA60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and HD-AraC(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (AML).

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: NCT06158100 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Venetoclax in Combination With Azacitidine (VEN/AZA) Followed by Donor Lymphocyte Infusion (DLI) for Patients With Very High-Risk Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)

Start date: July 31, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see the effects of an investigational combination treatment of venetoclax, azacitidine, and donor lymphocyte infusion (DLI) in patients with high-risk AML receiving allogeneic hematopoietic cell transplantation, and to assess if the combination treatment is well tolerated and prevents disease relapse after transplant.

NCT ID: NCT06152809 Active, not recruiting - Leukemia Clinical Trials

CIML NK Cells With Venetoclax for AML

Start date: February 20, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to test the safety and to explore the effectiveness of infusing cytokine- induced memory-like (CIML) natural killer (NK) cells in combination with Interleukin-2 (IL-2) and standard-of-care venetoclax as a treatment for Acute Myeloid Leukemia (AML). Names of the study therapies involved in this study are: - Lymphodepleting therapy with Fludarabine and Cyclophosphamide prior to CIML NK cell infusion - CIML NK (a cellular therapy) - IL-2 (a recombinant, human glycoprotein) - Venetoclax (a selective inhibitor of BCL-2 protein)

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.

NCT ID: NCT06143839 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

VYxeoS Liposomal Italian Observational Study iN the Real Practice

VYSION
Start date: December 7, 2023
Phase:
Study type: Observational

The study is a prospective, single-arm, non-experimental, observational study in patients in Italy with Acute Myeloid Leukaemia (AML) with myelodysplastic-related changes or therapy related AML initiating treatment with JZP351 (Vyxeos liposomal) in their normal clinical practice.