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Leukemia clinical trials

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NCT ID: NCT05046444 Recruiting - Leukemia Clinical Trials

Solving Riddles Through Sequencing

SIRIUS
Start date: January 19, 2022
Phase:
Study type: Observational

During the last decades hematologists have excelled at improving and refining the classification, diagnosis, and thus ultimately the therapeutic decision-making process for their patients. This continuous evolution proceeded in parallel to seminal discoveries in basic science such as FISH, PCR and NGS. So far, the current WHO classification serves as reference to diagnostic decision making and is largely based on 5 diagnostic pillars: cytomorphology of peripheral blood and/or bone marrow smears, histology and immunohistochemistry of bone marrow trephine biopsies or lymph nodes, immunophenotyping, chromosome banding analysis supplemented by FISH analysis, molecular genetics including PCR and targeted panel sequencing via NGS. This leads to a swift diagnosis in 90 % of all cases. The leftover 10 % remain a challenge for hematopathologists and clinicians alike and are resolved through interdisciplinary teams in the context of specialized boards. With the advent of high throughput sequencing (mainly WGS and WTS) the possibility of a comprehensive and detailed portrait of the genetic alterations - specifically in challenging cases - has become a realistic alternative to classical methods. In SIRIUS the investigators will prospectively challenge this hypothesis to address the question of how often a better or final diagnosis can be delivered by WGS and/or WTS and if unclear cases can be efficiently resolved.

NCT ID: NCT05043571 Recruiting - Clinical trials for Lymphoblastic Leukemia

CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia

Start date: September 8, 2021
Phase: Phase 1
Study type: Interventional

The objective of this study is to assess the safety and efficacy of anti-CD7 CAR T-cells in patients with refractory or relapsed T-lineage acute lymphoblastic leukemia (T-ALL).

NCT ID: NCT05042531 Recruiting - Clinical trials for Acute Myeloid Leukemia

Clinical Research for Azacitidine Combined With Low-dose Dasatinib in Maintenance Therapy of Acute Myeloid Leukemia

Start date: November 13, 2021
Phase: N/A
Study type: Interventional

This project is a prospective, single-center study to evaluate the efficacy, safety and related mechanisms of azacitidine combined with low-dose dasatinib in maintenance therapy in patients with intermediate and high-risk acute myeloid leukemia(AML). The patients were randomly divided into azacitidine group and azacitidine combined with low-dose dasatinib group. The overall survival and disease-free survival were taken as the main end points, and the mortality and recurrence rate were taken as the secondary end points, meanwhile, the incidence of adverse events were evaluated. At the same time, the mRNA expressions of DNA methyltransferase (DNMT1, DNMT3a, DNMT3b), tumor suppressor genes (TP53, P15, P16, P21, CDH1, DOK6, SHP1, PTPN11) and differentiation genes (pu.1, C/EBP α, C/EBP β) were detected. Pyrophosphate sequencing was used to detect the methylation level of the promoter region of these tumor suppressor genes. Western Blot was used to detect apoptosis proteins (caspase3, caspase8) and phosphorylated proteins (pSTAT3, pSTAT5, pAKT). The proportion of apoptotic population of bone marrow cells was determined by flow cytometry. Therefore, the data in this study will reflect the efficacy and safety of azacitidine or azacitidine combined with low-dose dasatinib in real-world maintenance therapy in patients with medium and high-risk AML.

NCT ID: NCT05038696 Recruiting - Clinical trials for Lymphoblastic Leukemia

ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.

ALaCART
Start date: April 28, 2021
Phase: Phase 1
Study type: Interventional

The objective of this study is to assess the safety and efficacy of a immunophenotype-adapted approach using CAR T-cells in patients with high-risk, refractory or relapsed B-lineage acute lymphoblastic leukemia (B-ALL).

NCT ID: NCT05038644 Recruiting - Clinical trials for Acute Myeloid Leukemia

XmAb18968 (CD3-CD38) in Relapsed or Refractory Acute Leukemia and T Cell Lymphoblastic Leukemia

Start date: February 2, 2022
Phase: Phase 1
Study type: Interventional

This is a phase 1, dose-escalation study (using 3 + 3 dose-limiting toxicity (DLT) criteria) evaluating the safety and tolerability of XmAb18968, as well as establishing a recommended phase II dose (RP2D) in subjects with T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic (lymphoma) T-LBL (Group A) and acute myeloid leukemia (AML) (Group B).

NCT ID: NCT05038592 Recruiting - Clinical trials for Chronic Myelomonocytic Leukemia

Tagraxofusp and Decitabine for the Treatment of Chronic Myelomonocytic Leukemia

Start date: March 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects, best dose, and effect of tagraxofusp and decitabine in treating patients with chronic myelomonocytic leukemia. Tagraxofusp consists of human interleukin 3 (IL3) linked to a toxic agent called DT388. IL3 attaches to IL3 receptor positive cancer cells in a targeted way and delivers DT388 to kill them. Chemotherapy drugs, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tagraxofusp and decitabine may help to control the disease in patients with chronic myelomonocytic leukemia.

NCT ID: NCT05035706 Recruiting - Clinical trials for Acute Myeloid Leukemia

Anti-Leukemia Immune Responses After Irradiation of Extramedullary Tumors

Start date: June 30, 2021
Phase: Early Phase 1
Study type: Interventional

This clinical trial assesses how the immune system responds to leukemia tumors after low dose radiation delivered as part of standard of care. The information learned in this study may help them know if adding immunotherapy (a type of treatment that uses the immune system to fight cancer) can be helpful in future leukemia patients receiving radiation.

NCT ID: NCT05035615 Recruiting - Acute Leukemia Clinical Trials

Evaluation of the BD OneFlow Acute Leukemia Panel on the BD FACSLyric Flow Cytometer

Start date: November 2, 2021
Phase:
Study type: Observational

This study is a multi-site, prospective performance study to determine equivalency between the investigational OneFlow Acute Leukemia Panel on the FACSLyric system versus the final clinical diagnosis.

NCT ID: NCT05032599 Recruiting - Clinical trials for T-Cell Acute Lymphoblastic Leukemia

Donor-Derived CD5 CAR T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia

Start date: September 14, 2021
Phase: Phase 1
Study type: Interventional

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia. At least 18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days. Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 2×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.

NCT ID: NCT05032183 Recruiting - Clinical trials for Recurrent Adult Lymphoblastic Lymphoma

Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Start date: February 17, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II trial studies the effects of tagraxofusp and low-intensity chemotherapy in treating patients with CD123 positive acute lymphoblastic leukemia or lymphoblastic lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Tagraxofusp consists of human interleukin 3 (IL3) linked to a toxic agent called DT388. IL3 attaches to IL3 receptor positive cancer cells in a targeted way and delivers DT388 to kill them. Chemotherapy drugs, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tagraxofusp with chemotherapy may help control CD123 positive relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma.