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NCT ID: NCT06250465 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

Start date: March 24, 2022
Phase:
Study type: Observational [Patient Registry]

For until very recently CLL has been considered an uncurable disease, with the only few exceptions of a part of patients capable of undergoing and successfully standing allogeneic stem cell transplant. However, the introduction of chemoimmunotherapy in particular the FCR (fludarabine, cyclophosphamide, rituximab) regimen has established a relevant population of IgVH mutated patients, who remain relapse-free for up to 10 years with a clear plateau at this level. However, for the largest proportion of all CLL patients the disease is still associated with a reduction in life expectancy as compared to a matched population. The field has made further substantial progress by the introduction of BTK inhibitors and Bcl2 inhibitors, novel antibodies as well as by the understanding of the role of minimal residual disease (MRD), mutations and their clonal evolution over time as risk factors and factors governing the kind and duration of therapy. Due to the limited follow up of frontline therapy trials using novel drugs, it is not yet clear, what the long-term results with many of the new drugs will be. Particularly, long-term PFS, the potential for cure and the long-term safety issues remain relevant parameters requiring examination, as are infections, interactions with other drugs or quality of life issues. CLL has not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of this disease.

NCT ID: NCT06247501 Recruiting - Clinical trials for Very High Risk Acute Lymphoblastic Leukemia

Treatment of CD19 Chimeric Antigen Receptor T Cells for Pediatric Patients With CD19-positive B-cell Acute Lymphoblastic Leukemia Who Are Indicated for Hematopoietic Stem Cell Transplantation

Start date: January 19, 2024
Phase: Phase 2
Study type: Interventional

This is a phase 2 clinical trial targeting pediatric and adolescent patients diagnosed with CD19-positive B-ALL, considered very high-risk group. The study aims to administer CD19 CAR-T therapy as an alternative to hematopoietic stem cell transplantation in patients eligible for such transplantation. The trial includes patients aged 25 or younger.

NCT ID: NCT06237192 Recruiting - Clinical trials for Precursor Cell Lymphoblastic Leukemia-Lymphoma

MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Non-intensive But Non-interruptive Treatment based on previously study RALL-2016 of Adult Ph-negative Acute Lymphoblastic Leukemia: No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remission (CR) with MRD-positive status after 2nd induction receive consolidation 1-3 with venetoclax (56 days), and B-ALL patients in complete remission (CR) with MRD-positive status after 2nd induction receive 1 consolidation with blinatumomab. After that consolidation bone samples are collected and tested for MRD and patients will continue therapy by protocol without HSCT if MRD-negative (by flow cytometry by aberrant immunophenotype in a centralized lab) status was achieved.

NCT ID: NCT06236724 Recruiting - Clinical trials for Chronic Myeloid Leukemia

Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

Start date: January 31, 2024
Phase: Phase 2
Study type: Interventional

To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.

NCT ID: NCT06235801 Recruiting - Myeloid Leukemia Clinical Trials

A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

Start date: May 22, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.

NCT ID: NCT06233526 Recruiting - Clinical trials for Acute Myeloid Leukemia in Children

Individualized Treatment of Pediatric R/R AML Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test

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

Acute myeloid leukemia (AML) accounts for about 15% to 20% of childhood leukemia, but the death rate accounts for about 50%. About 20-30% of children with AML did not achieve complete response (CR) after 2 induction treatments, and about 30% of children with CR had relapse within 3 years (including recurrence after hematopoietic stem cell transplantation).Relapsed/refractory (R/R) AML is a major cause of treatment failure and refractory survival. Reinduction chemotherapy for R/R-AML to obtain CR again, followed by hematopoietic stem cell transplantation, is the current treatment. At present, there is no recognized reinduction protocol, and the reinduction remission rate of R/R-AML varies greatly among different treatment regimens, ranging from 23 to 81%. Current guidelines recommend a new combination chemotherapy regimen consisting of new drugs without cross-resistance. This method selects sensitive chemotherapeutic drugs, and then forms a new combination chemotherapy regimen according to the characteristics of drugs, which is the choice of R/R-AML reinduction therapy.This study intends to conduct a clinical study on the individualized treatment of R/R AML patients through in vitro drug sensitivity test combined with patient transcriptomic characteristics.

NCT ID: NCT06232694 Recruiting - Clinical trials for Acute Myeloid Leukemia

Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML

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

This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML). This study includes the induction and consolidation phases of AML treatment.

NCT ID: NCT06229860 Recruiting - Clinical trials for Chronic Myeloid Leukemia

Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts w/Chronic Myeloid Leukemia

Start date: January 25, 2024
Phase:
Study type: Observational

This is an observational pilot study to examine the association between a patient's personality and adherence to tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia.

NCT ID: NCT06226571 Recruiting - Clinical trials for Acute Myeloid Leukemias

A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

Start date: May 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.

NCT ID: NCT06225128 Recruiting - Clinical trials for Acute Myeloid Leukemia

Dynamics of Resistance Emergence to Azacitidine-based Therapies in Acute Myeloid Leukemia

DREAM
Start date: January 16, 2024
Phase:
Study type: Observational

Acute myeloid leukemia (AML) is a malignancy of aging endowed with poor prognosis. The combination of the hypomethylating agent azacitidine (AZA) with the BCL-2 inhibitor venetoclax (VEN) is the first-line treatment of older AML patients but is endowed with substantial resistance. The project leverages functional precision oncology, single-cell studies and mouse experiments to dissect the mechanisms of primary and adaptive resistance to AZA/VEN. The primary objective is to prospectively validate an ex vivo drug sensitivity testing (DST) assay as predictor of primary resistance to first-line AZA/VEN in 100 unfit AML patients. The study will also explore whether newer DST assays with enhanced niche mimicry can improve on the standard assay. By serially interrogating the short-term fate of both leukemic and immune cells upon AZA/VEN exposure in patients primed towards refractoriness, transient or prolonged remission, the aim is to dissect the cell-intrinsic and immune-mediated mechanisms of primary versus adaptive resistance. A parallel flow cytometry study will interrogate the role of senescence in AZA/VEN activity. These translational studies will be mirrored by experiments in a transplantable AML model derived from syngeneic mice harboring the age-related Tet2-/- leukemia-predisposing genotype. Lineage tracing single-cell experiments will backtrack AZA/VEN resistance to determine whether it is driven by selection or adaptation. The actionable stress sensor Pml will be invalidated in the same model to determine whether Pml-driven senescence contributes to AZA/VEN anti-leukemic activity in vivo. The project will pave the way to the clinical implementation of functional precision oncology in a high-risk malignancy. By simultaneously interrogating cell-intrinsic and immune-mediated drug resistance in vivo in a prospective patient cohort mirrored by controlled mice experiments, the project will provide a framework for the integrative analysis of drug resistance in cancers.