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Leukemia, Myeloid clinical trials

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NCT ID: NCT06389292 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia

Start date: May 2024
Phase: Phase 3
Study type: Interventional

An international multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.

NCT ID: NCT06387420 Not yet recruiting - Clinical trials for ACUTE MYELOID LEUKEMIA; AML

A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia

Start date: April 29, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in subjects with AML.

NCT ID: NCT06387069 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study to Evaluate HMPL-306 in Patients With IDH1- and IDH2-mutated Acute Myeloid Leukemia

Start date: April 26, 2024
Phase: Phase 3
Study type: Interventional

An open-label design is adopted in this study. All patients will first undergo pre-screening to determine the mutation status of IDH, and all patients will be assigned to the registry study of the corresponding cohorts of IDH1 and IDH2 based on the pre-screening results. Patients with both IDH1 and IDH2 mutations will be enrolled in the IDH2 cohort. This study is divided into two cohorts. Cohort 1 includes R/R AML patients with IDH1-R132 mutations; Cohort 2 includes R/R AML patients with IDH2-R140 and R172 mutations. The two cohorts are designed independently and will be analyzed separately for statistical hypothesis testing. Patients in both cohorts will be randomized in a 1:1 ratio according to the central Interactive Web Response System (IWRS) into the test or control group, patients in the test group will receive HMPL-306 monotherapy at a dose of 250 mg once daily (QD) (Cycle 1, C1) + 150 mg QD [starting from Cycle 2 (C2)]. Patients in the control group will receive salvage chemotherapy (one of four options) consisting of two intensive chemotherapy regimens (MEC regimen and FLAG ± Ida regimen) and two non-intensive chemotherapy regimens (azacitidine and LoDAC)

NCT ID: NCT06386302 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

Start date: May 30, 2024
Phase: N/A
Study type: Interventional

To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy.

NCT ID: NCT06385808 Not yet recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients.

NCT ID: NCT06384261 Not yet recruiting - Clinical trials for Leukemia, Myeloid, Acute

A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

Start date: May 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine?

NCT ID: NCT06382168 Not yet recruiting - Clinical trials for Leukemia, Myeloid, Acute

Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia

Start date: May 31, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase I/II trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia. DFP-10917 is given as a 14-day continuous IV infusion every 28 days, alongside a 14-day oral course of venetoclax following an initial dose ramp-up. The initial phase tests a starting dose of 4 mg/m²/day of DFP-10917 with 400 mg daily of venetoclax. The Data Monitoring Committee reviews toxicity after one treatment cycle. If DLTs are minimal, more patients are added to confirm safety. If the lower dose level shows tolerability, it proceeds to the Phase II expansion to assess the treatment's effectiveness against leukemia using a Simon's two-stage design, targeting up to 17 participants.

NCT ID: NCT06379360 Recruiting - Clinical trials for Acute Myeloid Leukemia

Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients

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

HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk.

NCT ID: NCT06372717 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia, in Relapse

A Study to Investigate APL-4098 Alone and/or in Combination With Azacitidine in R/R AML and High-Risk MDS

Start date: April 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-4098 alone and/or in combination with azacitidine for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB). Participants with the MDS-EB subtype will be eligible for the Phase 1 part of the study only.

NCT ID: NCT06370000 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality

REMAIN1
Start date: June 1, 2024
Phase: Phase 4
Study type: Interventional

Test feasibility of an oral maintenance strategy for transplant eligible AML patients in first CR who are medically underserved or have a disadvantage in the CDC SDOH domains