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NCT ID: NCT05031897 Recruiting - Clinical trials for Acute Myeloid Leukemia

Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant

Start date: October 25, 2021
Phase: Phase 2
Study type: Interventional

This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.

NCT ID: NCT05026229 Recruiting - Clinical trials for Precursor Cell Lymphoblastic Leukemia-Lymphoma

A Study of Dasatinib Plus Reduced Intensive Consolidation Chemotherapy in Ph+ Adult ALL

Start date: September 6, 2021
Phase: N/A
Study type: Interventional

This project is a key clinical research project approved by the Clinical Research Center of the First Affiliated Hospital of Xi'an Jiaotong University. Tyrosine kinase inhibitors (TKI) combined with intensive chemotherapy has markedly improved the outcomes of philadelpha-positive lymphoblastic leukemia (Ph+ ALL). However, a considerable proportion of patients failed to complete the intended chemotherapy and some even died early. The optimal balance between the intensity of chemotherapy and safety should be explored. In this study, Ph+ ALL patients who achieve complete remission (CR) after VP regimen (vincristine and prednisone) plus dasatinib as induction are enrolled and then the participants will receive different consolidation chemotherapy. Patients in the group A will continue to use VP regimen plus dasatinib, while the group B receives hyper-CVAD/methotrexate-cytarabine regimen plus dasatinib. The measurable residual disease (MRD), CR, adverse effects (AE), overall survival (OS) and disease free survival (DFS) will be observed to determine the proper consolidation chemotherapy regimen.

NCT ID: NCT05024552 Recruiting - Clinical trials for Acute Myeloid Leukemia With FLT3/ITD Mutation

Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML

Start date: August 23, 2021
Phase: Phase 1
Study type: Interventional

This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy. Those patients entering a complete remission or a complete remission with incomplete blood count recovery will be allowed to proceed to consolidation therapy with vyxeos and gilteritinib. Those patients who do not proceed to an allogeneic stem cell transplant for any reason are able to enter the maintenance phase of this trial using daily gilteritinib

NCT ID: NCT05024357 Recruiting - Clinical trials for Precursor Cell Lymphoblastic Leukemia-Lymphoma

A Study of TKI Maintenance Therapy Following Allo-HSCT in Newly Diagnosed Ph+ Adult ALL

Start date: September 6, 2021
Phase: N/A
Study type: Interventional

This project is a key clinical research project approved by the Clinical Research Center of the First Affiliated Hospital of Xi 'an Jiaotong University.Tyrosine kinase inhibitors (TKI) combined with chemotherapy and subsequent allogeneic hematopoietic stem cell transplantation (allo-HSCT) are routinely used in patients with philadelpha-positive lymphoblastic leukemia (Ph+ALL). However, TKI maintenance therapy post-HSCT remains controversial. In this study, Ph+ALL patients are enrolled and given dasatinib combined with chemotherapy followed by allo-HSCT. Then patients in the group A continuing to use dasatinib for 1 year is compared with those in the group B receiving dasatinib for 6 months after HSCT. The measurable residual disease (MRD), complete remission (CR), overall survival (OS), disease free survival (DFS), non-relapse mortality (NRM) and the incidence of graft versus host disease (GVHD) will be observed to determine the optimal duration of TKI maintenance therapy post-HSCT.

NCT ID: NCT05023707 Recruiting - Clinical trials for Acute Myeloid Leukemia

Anti-FLT3 CAR T-cell Therapy in FLT3 Positive Relapsed/Refractory Acute Myeloid Leukemia

Start date: December 31, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective,open-label, phase1/2 study to evaluate the safety and efficacy of anti-FLT3 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of FLT3 positive relapsed or refractory acute myeloid leukemia.

NCT ID: NCT05020678 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers

Start date: August 20, 2021
Phase: Phase 1
Study type: Interventional

This is a single arm, open-label, multi-center, Phase 1 study to determine the safety and tolerability of an experimental therapy called NKX019 (allogeneic CAR NK cells targeting CD19) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or B cell acute lymphoblastic leukemia (B-ALL)

NCT ID: NCT05017883 Recruiting - Clinical trials for Acute Myeloid Leukemia

TAA05 Cell Injection in the Treatment of Recurrent / Refractory Acute Myeloid Leukemia

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

This is a clinical study of ytaa05 cell injection in the treatment of patients with recurrent / refractory acute myeloid leukemia.The purpose is to evaluate the safety and preliminary efficacy of FLT3 car-t cells in patients with recurrent / refractory FLT3 positive acute myeloid leukemia.#TAA05 cell injection is a T cell targeting FLT3 chimeric antigen receptor#

NCT ID: NCT05016947 Recruiting - B-Cell Lymphoma Clinical Trials

Venetoclax Plus Inotuzumab for B-ALL

Start date: September 24, 2021
Phase: Phase 1
Study type: Interventional

This research study is evaluating the safety and efficacy of administering venetoclax and inotuzumab ozogamicin in combination in patients with acute lymphoblastic leukemia (ALL) The names of the study drugs involved in this study are: - Venetoclax - Inotuzumab ozogamicin - Dexamethasone

NCT ID: NCT05016752 Recruiting - Clinical trials for Acute Myeloid Leukemia

Application of Nanopore Sequencing in Newly Diagnosed Acute Myeloid Leukemia Patients With Bloodstream Infection

Start date: August 5, 2021
Phase:
Study type: Observational

Acute myeloid leukemia (AML) patients are prone to blood stream infection (BSI) due to bone marrow suppression, oral and gastrointestinal mucositis, endovascular tubes, and the application of a large number of broad-spectrum antibiotics. The associated mortality rate is as high as 7.1 %-42%. The use of antibiotics within one hour after the first observation of hypotensive symptoms can guarantee a 79.9% survival rate. For every hour of delay, the patient's survival rate will drop by 7.6%. At present, the blood culture test cycle is long and the positive rate is low. Other infection-related indicators (PCT, CRP) or next-generation sequencing are not highly specific and easy to be misdiagnosed. X-ray, CT and other examinations only have a certain auxiliary value for the infected site. We need new diagnostic tools to accurately identify pathogens. Nano-seq is a next-generation sequencing technology for single-molecule, real-time sequencing and analysis. With ultra-long sequencing read length, it can quickly and accurately identify BSI pathogens types, and give appropriate drug sensitivity results based on drug resistance genes to meet the needs of 99.9% pathogen screening. At the same time, we hope to conduct a prospective evaluation to target high-risk groups of AML prone to BSI in the early stage. The intestine is the body's largest immune organ and the largest reservoir of microbial pathogens. The expansion of certain gut microbiota usually precedes BSI. If there is a correlation between the gut microbiota and MDR-BSI, the colonization and changes of the intestinal flora can be used to predict the risk of BSI in patients during treatment, and preventive measures such as early decolonization or biological intervention will reduce the risk of infection in the future. Combined with Nano-seq and various existing clinical pathogen detection technologies to reduce the occurrence and progress of clinical BSI.

NCT ID: NCT05015426 Recruiting - Clinical trials for Acute Myeloid Leukemia

Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT

Start date: March 21, 2022
Phase: Phase 1
Study type: Interventional

The purposes of the study are to determine the maximum tolerated dose (MTD) and effectiveness of Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion after an allogeneic hematopoietic cell transplant (alloHCT) to treat patients with Acute Myeloid Leukemia (AML).