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NCT ID: NCT05587088 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Evaluation of the Safety and Efficacy of Esperanza Extract (PA001)

PA001
Start date: December 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated, and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) with newly diagnosed acute leukemias and relapses.

NCT ID: NCT05587049 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Oral Venetoclax Tablets in Combination With Subcutaneously (SC) or Intravenously (IV) Injected Azacitidine in Colombia

ESVECO
Start date: November 16, 2023
Phase:
Study type: Observational

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax in combination with azacitidine works to treat AML in adult participants in Colombia. Venetoclax in combination with azacytidine is approved to treat Acute myeloid leukemia (AML). All study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML will be enrolled. Around 70 participants will be enrolled in the study in Colombia. Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) or intravenous (IV) injection according to the approved local label. The duration of the study is approximately 36 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.

NCT ID: NCT05586074 Recruiting - Clinical trials for Leukemia, Acute Myeloid (AML)

HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML

Start date: March 3, 2023
Phase: Phase 3
Study type: Interventional

A randomized,multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared to salvage chemotherapy, and also to investigate the efficacy of Clifutinib as assessed by CR/CRh rate in these subjects.

NCT ID: NCT05584761 Recruiting - Clinical trials for Myelodysplastic Syndromes

Unrelated Umbilical Cord Blood Stem Cell Combined With Azacitidine Based Treatment for Advanced MDS,CMML-2 and sAML

Start date: March 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This research is being done to study the efficacy and safety of unrelated umbilical cord blood stem cell microtransplantation combined with azacitidine(AZA) based treatment for advanced myelodysplastic syndromes(MDS), Chronic myelomonocytic leukemia-2(CMML-2) and secondary acute myeloid leukemia(sAML). The study protocol involved unrelated umbilical cord blood stem cell combined with azacitidine based treatment, which including azacitidine alone and azacitidine plus a targeted agent or chemotherapy agent.

NCT ID: NCT05581030 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Start date: May 1, 2023
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.

NCT ID: NCT05580861 Recruiting - Clinical trials for Acute Myeloid Leukemia

Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment

SALMA
Start date: May 17, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Acute myeloid leukemia (AML) is a heterogeneous clonal myeloid neoplasm where abnormal proliferation and impaired differentiation of hematopoietic stem and myeloid progenitor cells impedes normal hematopoiesis. Sulfasalazine (SSZ) is a broadly available, well tolerated anti-inflammatory medicine approved for the treatment of ulcerative colitis and rheumatoid arthritis. Intact SSZ, but not its metabolites 5-aminosalicylic acid and sulfapyridine, competitively inhibits xCT.21 SSZ is thus an ideal candidate for drug repurposing in AML.The purpose of this phase I study is to evaluate the safety and feasibility of such strategy, provide preliminary signals of efficacy, and identify potential biomarkers

NCT ID: NCT05580601 Recruiting - Clinical trials for Acute Myeloid Leukemia

Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)

Start date: May 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to demonstrate that cytokine-induced memory-like natural killer cells can be generated from donor cells and infused safely into patients with relapsed or refractory acute myeloid leukemia (AML). A secondary objective is to assess efficacy of the CIML-NK cells in treating AML.

NCT ID: NCT05579132 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

A Phase Ib/II Study of CN201 in Precursor B-cell Acute Lymphoblastic Leukemia

Start date: September 30, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

An effective treatment for adults and children B-ALL represents a significant unmet need. CN201 has demonstrated efficacy in nonclinical models of leukemia .CN201 has a longer half-life, thus long term continuous intravenous infusion is not necessary for clinical use. The present study will be conducted in 2 parts: Phase Ib is a dose finding phase to identify the RP2D. Phase II will allow further evaluation of the safety and efficacy of CN201 at the RP2D.

NCT ID: NCT05578378 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in R/R ALL

Start date: January 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

To explore the efficiency and safety of CLAG regimen in R/R ALL

NCT ID: NCT05577611 Recruiting - Clinical trials for UCB (Cord Blood) Microtransplantation in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

An Open, Single Center, Randomized Controlled Clinical Study of UCB (Cord Blood) in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

Start date: August 10, 2022
Phase: Phase 1
Study type: Interventional

In recent years, the curative effect of AML has been greatly improved. However, 20% - 30% of young patients and 40% - 50% of old patients will relapse again. Its re induction response rate is low, the survival period is short, and the prognosis is very poor. At present, there is no standard treatment scheme. Although a small number of patients can benefit from allogeneic hematopoietic stem cell transplantation (allo HSCT), most patients lack suitable donors. The choice of high-dose chemotherapy is a rescue treatment scheme, but the treatment-related hematology or non hematology related toxicity and high mortality make the scheme controversial, especially for the elderly. Some studies have proposed a new treatment method combining chemotherapy with peripheral blood hematopoietic stem cell infusion after mobilization of HLA mismatched donors. Preliminary clinical studies verified that after more than 70 cases of elderly acute myeloid leukemia were treated with microtransplantation, the complete remission rate reached 80%, the 2-year disease-free survival rate reached 39%, the early mortality rate was only 6.7%, and the median recovery time of neutrophils and platelets was 11 and 14.5 days, respectively, which was significantly different from the control group of chemotherapy alone. After that, the micro transplantation technology was extended to the treatment of myelodysplastic syndrome and lymphoma, and good results were also obtained. Compared with peripheral blood / bone marrow hematopoietic stem cells, umbilical cord blood (UCB) hematopoietic stem cells have the advantages of rapid access, convenient source, no harm to donors, and low requirements for HLA matching. The immune cells in cord blood hematopoietic stem cells are mostly Na ï ve and immature immune cells, so the incidence and severity of graft-versus-host disease (GVHD) after unrelated cord blood transplantation are low, which not only reduces the failure of transplantation due to GVHD, but also avoids a series of complications and high costs brought by complex GVHD prevention and treatment techniques. Because cord blood is rich in CD16 + CD56 + NK cells and CD3 + T cells, cord blood hematopoietic stem cell transplantation also plays an important role in GVL.