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AML, Adult clinical trials

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NCT ID: NCT06052813 Recruiting - AML, Adult Clinical Trials

A Study of BN104 in the Treatment of Acute Leukemia

Start date: September 16, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken once daily or twice daily in patients with acute lymphocytic leukemia or acute myeloblastic leukemia.

NCT ID: NCT06027853 Recruiting - AML, Adult Clinical Trials

Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia

Start date: September 10, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 target CAR iPSC NK cells in patients with relapsed/refractory AML

NCT ID: NCT06022003 Recruiting - AML, Adult Clinical Trials

Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia

OGILAR
Start date: January 13, 2024
Phase: Phase 2
Study type: Interventional

Approximately 30% of adult AML subjects are refractory to induction therapy. Furthermore, of those who achieve CR, approximately 75% will relapse. FLT3-mutated AML comprise an especially poor prognosis group. Until now, there was no established standard for relapsed subjects with FLT3 mutations and less than 20% will achieve CR with subsequent treatment. In phase 3 Study ADMIRAL Trial, gilteritinib has resulted in CRc in over 25% of subjects receiving 120 mg/day before on study HSCT. With this treatment, the median overall survival is at 9.3 months, furthermore, gilteritinib was well tolerated at the proposed doses. This study has been designed for R/R patients for which gilteritinib as single agent has been showed to be superior to high- and low-intensity chemotherapy (Perl, NEJM 2019, Supp Table S4) and patients included in this study will receive this treatment. Beyond high- or low-intensity chemotherapy, other options available are best supportive car or other clinical trials. The aim of this study is to assess the efficacy and safety of the addition of oral-azacitidine to salvage treatment by gilteritinib in subjects ≥18 years of age with relapsed/refractory FLT3-mutated acute myeloid leukemia

NCT ID: NCT06014489 Recruiting - AML, Adult Clinical Trials

A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML

HO171
Start date: January 17, 2024
Phase: Phase 2
Study type: Interventional

The treatment of older unfit patients with acute myeloid leukemia (AML) is challenging. The hypomethylating agents (HMA) azacitidine and decitabine have relatively mild side effects and have proven to be feasible for the treatment of older patients and patients with co-morbidities. Currently, venetoclax added to an HMA agent is the new standard of treatment. Since this new standard comes with a substantial societal financial burden, there is a rational to optimize the venetoclax dosing schedule. The CYP3A4 inhibitor cobicistat (COBI) can be used to increase venetoclax exposure, thereby allowing to reduce the dose of venetoclax and thus costs substantially.

NCT ID: NCT05987696 Not yet recruiting - Clinical trials for Minimal Residual Disease

Natural Killer(NK) Cell Therapy in Acute Myeloid Leukemia

Start date: August 10, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of iPSC NK cells in patients with relapsed/refractory AML or AML Minimal Residual Disease (MRD).

NCT ID: NCT05947344 Recruiting - AML, Adult Clinical Trials

A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)

Start date: December 8, 2023
Phase: Phase 1
Study type: Interventional

This is a first-in-human, dose-escalation and dose-expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of STI-8591 in subjects with advanced AML who have signed an informed consent form (ICF) and have been screened for enrollment in this study. - Dose escalation phase: rapid titration and conventional 3+3 test design were used to evaluate the safety, dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and PK characteristics of STI-8591. - Dose Expansion Phase: Evaluate the safety, preliminary efficacy and determine the recommended phase II dose (RP2D) of STI-8591 for the treatment of subjects with advanced AML under the conditions of reaching the expanded dose.

NCT ID: NCT05909501 Recruiting - AML, Adult Clinical Trials

Assessment of Geriatric Evaluations Impact on New AML Guidance

AGE-ING
Start date: October 25, 2023
Phase:
Study type: Observational

The goal of the study is to measure physiologic age (there is no current formal definition but is meant to imply that patients should be evaluated holistically rather than on age alone) at baseline in newly diagnosed AML patients over 50 years receiving either intensive or non-intensive treatment. This information will be used to evaluate toxicity, early mortality, remission rates and long term survival.

NCT ID: NCT05839392 Recruiting - AML, Adult Clinical Trials

Novel Approaches to Target MECOM/EVI1 in AML

Start date: December 13, 2023
Phase: N/A
Study type: Interventional

This is an academic, no-profit, multicenter, biological, non-pharmacologic study aimed at characterizing genome, transcriptome and proteome of patients affected by AML with MECOM or atypical 3q26 rearrangements.

NCT ID: NCT05736965 Recruiting - AML, Adult Clinical Trials

A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia

SAV
Start date: February 20, 2023
Phase: Phase 2
Study type: Interventional

This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia.

NCT ID: NCT05665114 Recruiting - AML, Adult Clinical Trials

Natural Killer(NK) Cell Therapy in r/r AML

Start date: December 24, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in relapse/refractory Acute Myeloid Leukemia (AML). This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-030a in patients with r/r AML, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.