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Leukemia, Myeloid clinical trials

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NCT ID: NCT06211153 Completed - Clinical trials for Chronic Myeloid Leukemia With T315I Mutation

Real-world Effectiveness of Asciminib and Treatment Patterns in Patients With Chronic Myeloid Leukemia With T315I Mutation - a Chart Review Study of Patients Treated in the Asciminib Managed Access Program (MAP)

Start date: December 31, 2021
Phase:
Study type: Observational

This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.

NCT ID: NCT06148493 Completed - Clinical trials for Chronic Myeloid Leukemia

Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database

Start date: September 20, 2022
Phase:
Study type: Observational

This was a retrospective descriptive analysis of health care claims data using the IQVIA open source medical and pharmacy claims databases. Patients were grouped into one of two cohorts depending on the index medication. All patients with at least 1 pharmacy claim for asciminib occurring between 01 January 2021 and 30 April 2022 in (Phase 1) were grouped into the asciminib cohort. A data refresh was conducted (Phase 1 refresh) and all patients with at least 1 pharmacy claim for asciminib occurring between 01 January 2021 and 29 August 2022 were included in the asciminib cohort. Patients were required to have at least 6 months of continuous data availability prior to the start of treatment and were followed from the start of treatment until the end of available follow-up. The end of available follow up in open source data was defined as 1) last claim date in medical or pharmacy data, OR 2) last day of index pharmacy stability, OR 3) end of study period, whichever came first. While no post-index data availability were required in Phase 1, a subgroup analysis was conducted in patients with at least 3 and 6 months of available follow-up after the index date in Phase 1 refresh. In Phase 2 of the study, patients with no exposure to asciminib and with at least 1 pharmacy claim for imatinib mesylate, dasatinib, nilotinib, bosutinib or ponatinib were indexed to the first new tyrosine kinase inhibitor (TKI) observed between 01 January 2021 and 29 August 2022 and grouped into the other TKI cohort. The index date was the initiation date of the index medication. Patients were required to have linkage to the open-source medical claims database and at least 3 months of available follow-up after the index date.

NCT ID: NCT05893836 Completed - Clinical trials for Chronic Myeloid Leukaemia

Real-World Disease Management and Outcomes in Chronic Myeloid Leukaemia

Start date: April 27, 2021
Phase:
Study type: Observational

Chronic myeloid leukaemia (CML) diagnosis is based on the demonstration of a BCR-ABL fusion transcript expressed by the Philadelphia (Ph) chromosome by RQ-PCR and/or the demonstration of t(9;22)(q34;q11) by conventional karyotyping or interphase FISH. As per standard practice, response to therapy is monitored using either molecular or cytogenetic tests or both; specifically, patients are monitored by quantitative PCR on peripheral blood, supplemented by bone marrow karyotyping if it was clinically indicated. ABL kinase mutational analysis is carried out when the transcript ratio has increased over two sequential samples or on clinical demand. Testing for T315I mutation is also performed for patients who fail to respond to first line TKI and all patients who acquire TKI resistance over the course of their treatment. Data collection is initiated six months after date of diagnosis; research nurses working to agreed operating procedures and data standards visit each of the 14 hospitals in the region and abstract a core clinical dataset from the patients' medical records. The information collected includes demographic details, baseline blood count data and first line treatment. All details are abstracted onto structured forms and entered onto the web-based system, which integrates Haematological Malignancy Research Network (HMRN) and Haematological Malignancy Diagnostic Service (HMDS) data. An important feature of data acquisition is the emphasis on primary source information; data from radiology reports, blood tests, clinical examination, and clinician summaries are recorded, enabling embedded algorithms in the database system to automatically generate stage and prognostic scores. Further data abstraction from the medical records has been undertaken to capture information on subsequent treatment lines. Information on date and cause of death were obtained from the National Health Service (NHS) Central Register.

NCT ID: NCT05734053 Completed - Clinical trials for Chronic Myeloid Leukemia

Nilotinib for Patients With Chronic Myeloid Leukemia in First Line and Any Subsequent Line

NOFRETETE
Start date: June 28, 2016
Phase:
Study type: Observational

This was a non-interventional observational study within the routine chronic myeloid leukemia treatment practice; no further tests were required apart from the assessments routinely performed for Chronic myeloid leukemia patients treated with nilotinib.

NCT ID: NCT05696457 Completed - Clinical trials for Hematopoietic Stem Cell Transplantation

Effects of Music Therapy in Controlling Symptoms in Patients With AML and Undergoing HSCT

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

The goal of this clinical trial is to test passive music therapy in patients receiving induction chemotherapy for an acute myeloblastic leukemia or undergoing an hematopoietic stem cell transplantation. The main questions it aims to answer are: - Can music therapy control physical and psychological symptoms and improve the mood and quality of life of these patients? Participants will be randomly assigned to the control and experimental group. Patients included in both groups will complete weekly mood and quality of life questionnaires. Those included in the experimental group will also complete daily symptom burden questionnaires before and after listening to a music therapy session. Researchers will confirm if the experimental group improves their symptoms after the music therapy session and will compare both groups to see if there are differences in mood and quality of life.

NCT ID: NCT05640804 Completed - Clinical trials for Leukemia, Myelogenous, Chronic

A Bioequivalence Study of Dasatinib Tablet

Start date: September 9, 2018
Phase: Phase 1
Study type: Interventional

This is a clinical study to evaluate the bioequivalence of dasatinib tablet produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Sprycel® produced by Bristol Myers Squibb after single dose in healthy subjects, so as to provide reference for clinical evaluation and clinical medication; to observe the safety of the dasatinib tablet and the reference drug Sprycel® in healthy subjects under fasting and fed states.

NCT ID: NCT05619978 Completed - Clinical trials for Chronic Myeloid Leukemia

French Study to Highlight the Unmet Treatment Needs of 3L+ CP-CML and With T315I-mutated CML Patients

Start date: May 3, 2021
Phase:
Study type: Observational

A retrospective multi-center cohort study design was used to address the study objectives, using medical records obtained from three clinical centers in France.

NCT ID: NCT05611216 Completed - Clinical trials for Chronic Myeloid Leukemia

Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation

Start date: December 1, 2020
Phase:
Study type: Observational

The study was a retrospective, non-interventional patient chart review and used a panel of oncologists/hematologists from the US to collect real-world clinical outcomes of patients with CML-CP in 3L+ and those with the T315I mutation.

NCT ID: NCT05563207 Completed - Clinical trials for Acute Myeloid Leukemia

Application of Health Education Path of Traditional Chinese Medicine Nursin

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

To explore the effect of traditional Chinese medicine (TCM) health education standard path on the treatment of patients with acute myeloid leukemia (AML). A total of 60 patients with acute myeloid leukemia in Shijiazhuang Ping An Hospital were selected and divided into control group (n=30) and observation group (n=30) according to the time of admission. Both groups received the same chemotherapy, the control group received routine nursing, and the observation group received TCM health education standard path intervention. The scores of Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Spitzer Quality of Life Index (QLI), awareness of TCM health education standard path content and nursing satisfaction were compared between the two groups.

NCT ID: NCT05541224 Completed - Clinical trials for Acute Myeloid Leukemia

A Retrospective Epidemiologic Registry to Gain Insight Into the Characteristics and Prognosis of AML Patients According to the Routinely Used Genetic and Biologic Markers

Start date: November 1, 2019
Phase:
Study type: Observational

This is a retrospective, translational, epidemiologic, multicenter, non-interventional study (No EPA study) to provide insights into disease epidemiology, disease biology, treatment regimens, and clinical outcomes of patients with acute myeloblastic leukemia (AML) in routine clinical practice according to their molecular markers. The primary objective of the study is to describe the use of the main molecular markers (FLT3 and NPM1) in the real-life according of the type of AML, treating institution, patients' characteristics, and disease status.