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Leukemia, Myeloid clinical trials

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NCT ID: NCT04621851 Recruiting - Clinical trials for Chronic Myeloid Leukemia

Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation

Start date: September 30, 2020
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to investigate the safety profile of TKI discontinuation in clinical practice, with particular regard on the risk of progression after treatment discontinuation.

NCT ID: NCT04613622 Recruiting - Clinical trials for Acute Myeloid Leukemia

Pharmacokinetics of Venetoclax in Patients With Acute Myeloid Leukemia

Start date: August 1, 2020
Phase:
Study type: Observational

Venetoclax is a treatment for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). However, the pharmacokinetic data in Chinese population, as well as the change of venetoclax plasma concentration while taking CYP enzyme inducers or inhibitors, remained unknown so far. Therefore, the aim of this study is to investigate the pharmacokinetic characteristics of venetoclax.

NCT ID: NCT04589728 Recruiting - Clinical trials for Acute Myeloid Leukemia

Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit AML Patients Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96

Start date: February 23, 2021
Phase:
Study type: Observational

This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in AML patients unfit for intensive chemotherapy in a "real-life" scenario. No additional procedures or visits other than those required by normal clinical practice will be required. Patients will be observed for at least 24 months.

NCT ID: NCT04582864 Recruiting - Clinical trials for Relapsed Acute Myeloid Leukemia

Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)

Start date: May 20, 2021
Phase: Phase 2
Study type: Interventional

The investigators hypothesize that flotetuzumab for relapsed AML following allo-HCT will be safe, tolerable and may facilitate preferential immune effector cell retargeting of leukemic cells resulting in improved patient outcomes. Furthermore, administration of a donor lymphocyte infusion (DLI) (if available) in combination with flotetuzumab will be safe, tolerable and may provide additional therapeutic efficacy.

NCT ID: NCT04541277 Recruiting - Clinical trials for Acute Myeloid Leukemia, Elderly, Unfit

Combined Inhibition of PD-1 and DNA Hypomethylating Agent +/- Chemotherapy in High-risk AML or Elderly Patients With AML Who Are Unfit for Intensive Chemotherapy

Start date: September 1, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well tislelizumab combined with DNA hypomethylation agent +/- CAG regimen (cytarabine, idarubicin / Aclarithromycin, rhG-CSF/ PEG-rhG-CSF) work in treating patients with high-risk acute myeloid leukemia (AML) or AML patients older than 60 years of age who are unfit for standard-dose chemotherapy. The expressions of PD-1 and PD-L1 are increased in AML cells. However, blocking the immune checkpoint alone has limited efficacy as a single agent in highly proliferative leukemia cells. During the recovery period after cytotoxic chemotherapy, the activation of PD-1/PD-L1 pathway may be increased and DNA hypomethylation agents can also up-regulate PD-1, PD-L1 and PD-L2 in AML patients. The up-regulation and activation of above immune checkpoint molecules are related to chemotherapy resistance. Therefore, adding chemotherapy and epigenetic regulation agents to Immune checkpoint blockade therapy may work better through overcoming drug resistance in AML treatment.

NCT ID: NCT04501120 Recruiting - Myeloid Malignancy Clinical Trials

Study of APG2575 Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML

Start date: September 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, pharmacokinetic profile of APG-2575 single agent and in combination with HHT/AZA in patients with relapsed/refractory AML and related myeloid malignancies.

NCT ID: NCT04500587 Recruiting - Clinical trials for Acute Myeloid Leukemia

Phase 1 First in Human Study of ZN-d5 as a Single Agent

Start date: October 13, 2020
Phase: Phase 1
Study type: Interventional

Phase 1 dose escalation study of ZN-d5 in subjects with relapsed or refractory non-Hodgkin lymphoma (NHL) or acute myeloid leukemia (AML).

NCT ID: NCT04493164 Recruiting - Clinical trials for Myelodysplastic Syndrome

CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Start date: December 30, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial investigates how well CPX-351 and ivosidenib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation. The safety of this drug combination will also be studied. IDH1 is a type of genetic mutation (change). Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to learn if CPX-351 in combination with ivosidenib can help to control IDH1-mutated acute myeloid leukemia or high-risk myelodysplastic syndrome.

NCT ID: NCT04490707 Recruiting - Clinical trials for Acute Myeloid Leukemia in Remission

Study of Azacytidine Combined With Lenalidomide As Maintenance Therapy Based on MRD Monitoring in AML

Start date: September 1, 2020
Phase: Phase 3
Study type: Interventional

Great progress has been witnessed on the treatment of acute myeloid leukemia (AML) in recent years. However, elderly patients ineligible for receiving high dose chemotherapy and allo-HSCT, have high relapse rate and treatment-related complications. Azacitidine (AZA), a listed hypomethylating agent in China in 2018, is the only approved demethylating drug in the treatment of AML, following the NCCN guidelines. In addition, lenalidomide(LEN) has been shown to rapidly enhance cytotoxic T- and natural killer (NK)-cell function and reduce relapse post-chemotherapy in patients with MM, also has substantial activity as a single agent in elderly patients with AML. Measurable residual disease (MRD) has been proven to be highly prognostic in quite a number clinical studies. This study is aimed to validate the efficacy and safety advantages of the maintenance therapy that contain AZA and LEN in elderly or unfit for intensive therapy patients with AML based on MRD monitoring.

NCT ID: NCT04471064 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of XY0206 Tablets in Patients With Relapsed / Refractory Acute Myeloid Leukemia

Start date: September 15, 2020
Phase: Phase 1
Study type: Interventional

1. To evaluate the safety and tolerability of xy0206 as single drug in the treatment of relapsed / refractory AML; 2. Evaluate the dose limited toxicity (DLT) and maximum tolerable dose (MTD) of xy0206 as single drug in the treatment of relapsed / refractory AML subjects. 3. To evaluate the pharmacokinetic (PK), pharmacokinetic (PD) characteristics and PK / PD correlation of xy0206 as single drug treatment in relapsed / refractory AML subjects; 4. To evaluate the primary efficacy of xy0206 as single drug in the treatment of relapsed / refractory AML patients; 5. To evaluate biomarkers of xy0206 as single drug treatment for relapsed / refractory AML subjects.