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Leukemia, Myeloid, Acute clinical trials

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NCT ID: NCT05100303 Not yet recruiting - Clinical trials for Treatment-naive or Relapsed or Refractory Acute Myeloid Leukemia (AML)

A Study to Evaluate the Tolerance and Efficacy of Mitoxantrone Hydrochloride Liposome Injection Combined With Cytarabine in Patients With Acute Myeloid Leukemia (AML)

Start date: December 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multi-cohort, multi-center Phase Ib/II clinical study to evaluate the tolerance and efficacy of Mitoxantrone Hydrochloride liposome injection combined with cytarabine in patients with Acute Myeloid Leukemia (AML). The study will be divided into two phases, the dose escalation phase and the dose expansion phase. Patients with relapsed or refractory(R/R) AML will be included in the dose-escalation phase, and patients with treatment-naïve or R/R AML will be included in the dose-expansion phase.

NCT ID: NCT05016063 Not yet recruiting - Clinical trials for Leukemia, Myeloid, Acute

Dual CD33-CLL1-CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

Start date: September 1, 2021
Phase: Early Phase 1
Study type: Interventional

Phase I, interventional, single-arm, open-label, treatment study to evaluate the safety and effectiveness of CD33-CLL1 CAR in patients with relapsed and/or refractory acute myeloid leukemia (AML).

NCT ID: NCT04946890 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia Leukemia

A Study of MRX2843 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Start date: July 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Patients will receive oral MRX2843 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.

NCT ID: NCT04861207 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia Myelodysplastic Syndromes

Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With AML (Acute Myeloid Leukemia) and Myelodysplastic Syndromes

CLARA
Start date: June 30, 2021
Phase: Phase 2
Study type: Interventional

A single center, prospective, one arm clinical study to assess the tolerance and effectiveness of total body irradiation and cladribine in adult patients diagnosed with AML( acute myeloid leukemia) and myelodysplastic syndromes.

NCT ID: NCT04824924 Not yet recruiting - Clinical trials for Leukemia, Myeloid, Acute

A Phase 2 Study of Venetoclax in Combination With Low-dose HHT, G-CSF, and AZA as First-line Treatment for Newly Diagnosed Elderly AML Patients Unfit for Intensive Chemotherapy

Start date: March 2021
Phase: Phase 2
Study type: Interventional

Acute myeloid leukemia (AML) is a group of heterogeneous malignancies derived from hematopoietic precursors. Patients older than 65 years can hardly benefit from standard intensive chemotherapy while having a poor toxicity tolerance, leading to a dismal prognosis. Currently, there is no satisfactory treatment modality for this high-risk patient population, which is an unmet clinical need. Venetoclax (ABT-199/GDC-0199, VEN) is a highly selective, oral B-cell lymphoma 2 (BCL-2) inhibitor that has shown activity in BCL-2- dependent leukemia and lymphoma cell lines, and has recently exerted encouraging therapeutic effect with manageable toxicity profile in the field of treatment of AML. Promising results have emerged in the combination of venetoclax and hypomethylating agents (HMA), decitabine or azacitidin (AZA), producing complete remission (CR) plus CR with incomplete hematologic recovery (CRi) rates of 74% and 66.7%, respectively, in previously untreated elderly AML patients. Homoharringtonine (HHT) is an alkaloid and has been used in Chinese patients with acute and chronic myeloid leukemia for more than 30 years. The add of HHT to the combination of cytarabin and aclarubicin or daunorubicin has been proved to improve CR rate and prognosis of AML patients. Moreover, HHT combined with low-dose cytarabine and granulocyte colony-stimulating factor (G-CSF) has achieved durable efficacy in AML patients, either in the first-line or salvage setting. Interestingly, HHT has potent synergistic effects with VEN through reducing the expression of BCL-XL and MCL-1 in BCL-2 related pathways as previouly reported. This study aims at investigating the combination of HHT, VEN, AZA and G-CSF (HVAG) in the treatment of newly diagnosed elderly AML patients who are ineligible for intensive chemotherapy.

NCT ID: NCT04743115 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia, Myelodysplastic Syndrome

A Phase I, Open-Label, Dose Escalation and Cohort Expansion Study of BS HH 002.SA in Patients With AML and MDS

Start date: February 2021
Phase: Phase 1
Study type: Interventional

Indication:Relapsed or refractory AML in patients for whom no established treatment options are available (this indication will heretofore be referred to as the protocol AML indication), or adult patients with MDS who are classified as high risk or very high risk according to the Revised International Prognosis Scoring System (IPSS-R). Number of Investigators and Study Centers:Up to 5 Investigators in the US. Objectives:Dose Escalation Part Primary Objective: 1. To determine the maximum tolerated dose (MTD) of BS HH 002.SA administered subcutaneously once per day for 12 days of a 28-day cycle. Secondary Objectives: 2. To provide an initial safety profile of single and multiple cycles of BS HH 002.SA. 3. To assess the pharmacokinetic (PK) profile of BS HH 002.SA. 4. To explore the anti-tumor activity of BS HH 002.SA in patients with the protocol AML indication or high-risk MDS. 5. To explore cytogenetics of the malignant cells in relation to response to BS HH 002.SA. Cohort Expansion Part Primary Objectives: 1. To evaluate safety and tolerability of BS HH 002.SA at MTD and/or lower dose level (DL) in selected cohorts of patients with the protocol AML indication or high-risk MDS. 2. To evaluate preliminary anti-tumor activity of BS HH 002.SA at MTD and/or lower DL in selected cohorts of patients with the protocol AML indication or high-risk MDS. Secondary Objectives: 3. To assess the PK profile of BS HH 002.SA. 4. To explore cytogenetics of the malignant cells in relation to response to BS HH 002.SA. Study Population:Adult patients with the protocol AML indication or high-risk MDS.

NCT ID: NCT04716452 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia, in Relapse

Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

KNAN2001
Start date: June 1, 2024
Phase: Phase 1
Study type: Interventional

The study explores whether Ceramide NanoLiposome (CNL) combined with other conventional cancer-fighting drugs makes them work better.

NCT ID: NCT04709458 Not yet recruiting - Clinical trials for Acute Myelogenous Leukemia

Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis

Start date: September 1, 2022
Phase: Phase 1
Study type: Interventional

This is a study of allogeneic stem cell transplantation with TBX-2400 in adult subjects with Acute Myelogenous Leukemia (AML) or Myelofibrosis (MF). The donor cells are exposed to a protein that has been shown in the laboratory to improve the ability of the donor cells to make blood and immune cells after transplant. Exposure of the donor cells to this protein does not modify the genes in the cells in any way. This study has two goals. The first goal is to find out if transplant with TBX-2400 is safe. The second goal is to find out what effects TBX-2400 stem cells have on time to engraftment in adult subjects with AML or MF. The study hypothesis is that TBX-2400 cells will shorten the time to immune reconstitution after transplant.

NCT ID: NCT04708444 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Prognostic Value of CD318 in AML at Assiut University Hospital.

Start date: March 2021
Phase:
Study type: Observational

We will focus on the prognostic value of CD318 in acute myeloid leukemia patients at Assiut University Hospital

NCT ID: NCT04658004 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

NKG2D CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Myeloid Leukemia

Start date: January 15, 2021
Phase: Early Phase 1
Study type: Interventional

A Study of NKG2D CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Myeloid Leukemia.