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Leukemia, Myeloid clinical trials

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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: NCT05983172 Enrolling by invitation - Clinical trials for Acute Myeloid Leukemia

Multi-omics Approach of Risk Stratification for Patients With de Novo Acute Myeloid Leukemia

Start date: August 2023
Phase:
Study type: Observational [Patient Registry]

The investigators will use machine learning to identify features on bone marrow smears and select features that are related to gene mutations, gene expression, or prognosis. The investigators will then use genome-wide transcriptomic profiling to investigate gene expression that is associated with patients' outcomes. The investigators will design a next-generation sequencing panel with unique molecular index and assess its feasibility and robustness in detecting measurable residual disease and optimize the panel/platform/bioinformatic pipeline. Finally, The investigators will use machine learning to integrate bone marrow smear features, gene mutations, gene expression, and measurable residual disease to construct a comprehensive risk assessment system that is based on multi-omics data. The investigators believe that such a platform will help physicians to design the most appropriate treatment strategies for individual patients, not only advancing the concept of precision medicine but also improving patients' prognoses.

NCT ID: NCT05919199 Enrolling by invitation - Clinical trials for Acute Myeloid Leukemia

PET Tracer Based FDG Signal for Predicting Prognosis in Acute Myeloid Leukemia

FDG-PETAML
Start date: January 3, 2023
Phase:
Study type: Observational

The purpose of this study is to evaluate the predictive value of 18F-FDG PET probe signal in de novo diagnosed or refractory/relapsed patients with acute myeloid leukemia. It is hypothesized that the intensity of 18F-FDG signal, an indicator of glucose uptake capacity, in various cell subsets of bone marrow will improve the predictive effect of clinical standard prognostic work-up.

NCT ID: NCT04836390 Enrolling by invitation - Clinical trials for Acute Myeloid Leukemia

Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults With High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant

EXCEL
Start date: August 24, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase II pilot study to determine the efficacy of three fixed dose (1 x 108/kg) infusions of ex-vivo expanded human leukocyte antigen (HLA)-haploidentical donor natural killer (NK) cells (haploNK) in children and young adults with high risk acute myeloid leukemia (AML) undergoing HLA-haploidentical hematopoietic cell transplant (haploHCT) with a busulfan and cyclophosphamide-based myeloablative conditioning regimen and post-transplant cyclophosphamide (PTCy) for graft versus host disease (GVHD) prophylaxis. The investigators will also demonstrate the feasibility of performing this trial in a multi-center study. The investigators hypothesize that the infusion of haploNK in this setting will facilitate immune reconstitution and decrease relapse rates and infectious complications without increasing GVHD, resulting in improved survival as compared to recent historical cohorts of haploHCT without NK cell infusion.

NCT ID: NCT04093570 Enrolling by invitation - Clinical trials for Acute Myeloid Leukemia

A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers

Start date: September 30, 2019
Phase: Phase 2
Study type: Interventional

Extension study to provide ongoing long-term treatment with ASTX727 for participants who were benefitting from ASTX727 treatment in a previous Astex-sponsored clinical study of ASTX727 (including, but not limited to ASTX727-01 [NCT02103478], ASTX727-02 [NCT03306264], ASTX727-04 [NCT03813186]), and Food Effect Substudy to obtain survival information and long-term safety information. The purpose of the Food Effect Substudy is to evaluate the pharmacokinetics (PK) and safety of decitabine and cedazuridine when ASTX727 is given under fed (high-calorie/high-fat meal or low-calorie/low-fat meal) versus fasted conditions.

NCT ID: NCT03902665 Enrolling by invitation - Clinical trials for Acute Myeloid Leukemia, Adult

Up-front Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients Aged 65-75

Start date: March 15, 2019
Phase: Phase 2
Study type: Interventional

Patients with acute myeloid leukemia aged 65-75 have a very poor prognosis, irrespective of the treatment strategy, including demethylating agents or conventional chemotherapy. With these approaches, remission rates do not exceed 40%, and overall disease-free survival at 1 year is in the order of 15%. The hypothesis is that up-front allogeneic hematopoietic stem cell transplant will produce a complete remission rate of 60% on day +56-70, and disease-free survival at 1 year of 30%. This is a single arm phase II study of upfront allogeneic stem cell transplantation, for patients with acute myeloid leukemia aged 65-75: the primary endpoint is a complete remission rate on day +56-70. The secondary endpoint is a 1-year overall disease-free survival of 30%.

NCT ID: NCT03642236 Enrolling by invitation - Clinical trials for Acute Myeloid Leukemia

Combination of BTK Inhibitor Overcomes Drug-resistance in Refractory/Relapsed FLT3 Mutant AML

Start date: August 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Clinical efficacy of FLT3 inhibitors combining with chemotherapy is usually transient and followed by emergence of drug-resistance in FLT3-ITD mutant AML. BTK is reported to be a therapeutic target in this subtype leukemia. Our previous study showed inhibition of BTK onvercome drug-resistance to FLT3 inhibitors/chemotherapy in refractory/relapsed FLT3 mutant AML. In this prospective randomized controlled study, the efficacy and safety of combination of BTK inhibitor with chemotherapy with/without FLT3 inhibitor in refractory/relapsed FLT3 mutant AML are evaluated.

NCT ID: NCT03507842 Enrolling by invitation - Clinical trials for Acute Myeloid Leukemia

A Prospective Randomized Comparison of HDAC vs AD in the Induction Chemothrapy for AML.

Start date: March 1, 2018
Phase: Phase 3
Study type: Interventional

This trial is a single-center, non-blind, two-arm randomized prospective controlled trial to compare the effectiveness of two induction chemotherapy regimens (high-dose cytarabine plus daunorubicin [HDAC] vs. cytarabine plus high-dose daunorubicin [AD]) in acute myeloid leukemia (AML). The primary hypothesis of the study is that AD is superior to HDAC in terms of event-free survival (EFS, time from registration to induction failure, relapse, or death).

NCT ID: NCT03348033 Enrolling by invitation - Clinical trials for Chronic Myeloid Leukemia

Safety and Feasibility of the Use of Natural Killer Cells in Patients With Chronic Myeloid Leukemia

Start date: March 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety, feasibility and maximum tolerated dose of NK cells cultured in vitro as adjuvant treatment of patients with chronic myeloid leukemia candidates to allogenic bone marrow transplantation or refractory to conventional treatment.

NCT ID: NCT02985372 Enrolling by invitation - Clinical trials for Acute Myeloid Leukemia, Adult

Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia

Start date: December 2016
Phase: Phase 3
Study type: Interventional

This prospective multicenter clinical study was designed to assess the efficacy and safety of decitabine in combination with low-dose cytarabine induction treatment for elderly patients with newly diagnosed acute myeloid leukemia (AML).