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Leukemia, Myeloid, Acute clinical trials

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NCT ID: NCT05077423 Terminated - AML, Childhood Clinical Trials

A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia

Start date: May 25, 2022
Phase: Phase 1
Study type: Interventional

Pediatric patients (<21 years at study entry) with relapsed or refractory acute myeloid leukemia (AML) will be treated with CD33*CD3 a bispecific antibody to investigate the safety and tolerability of the drug.

NCT ID: NCT05066165 Terminated - Clinical trials for Acute Myeloid Leukemia

Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia

Start date: December 17, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will be conducted to evaluate the safety, tolerability, cellular kinetics (CK), activity, and pharmacodynamics (PD) of NTLA-5001 in participants with Acute Myeloid Leukemia (AML).

NCT ID: NCT05038800 Terminated - Clinical trials for Relapsed or Refractory Acute Myeloid Leukemia

A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002)

Start date: September 26, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and recommended Phase 2 dose (RP2D) of MK-0482. There are 2 parts of this study. Part 1 is a dose escalation which will follow an accelerated titration design (ATD) for participants with relapsed/refractory (R/R) AML or CMML. Part 2 is a dose expansion for participants with R/R AML.

NCT ID: NCT05028751 Terminated - Clinical trials for Acute Myeloid Leukemia

A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)

Start date: August 5, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety of lanraplenib (LANRA) in combination with the FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib, in participants with relapsed or refractory (R/R) FLT3-mutated acute myeloid leukemia (AML).

NCT ID: NCT05020665 Terminated - Clinical trials for Nucleophosmin 1-mutated Acute Myeloid Leukemia

Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML

Start date: November 24, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as defined by the rate of molecularly defined measurable residual disease (MRD).

NCT ID: NCT05001451 Terminated - Clinical trials for Acute Myeloid Leukemia

Study of GDX012 in Patients With MRD Positive AML

Start date: August 13, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this first-in-human study is to assess the safety, tolerability, antileukemic activity and maximum tolerated dose (MTD) of GDX012 in AML patients who are MRD positive by multiparametric flow cytometry. The study will consist of a dose escalation stage to evaluate various doses of GDX012 after a lymphodepletion regimen comprising fludarabine and cyclophosphamide. Following determination of the MTD of GDX012, the study will expand at the MTD. Patients will be followed up for 12 months, after receiving GDX012.

NCT ID: NCT04968860 Terminated - Clinical trials for Leukemia, Myeloid, Acute

Oral Health Condition and Quality of Life in Children With Leukemia

Start date: September 1, 2019
Phase:
Study type: Observational [Patient Registry]

Among the different types of cancer that most affect children, leukemia is the principal. One of the main treatments for leukemia is chemotherapy. Among the most common side effects of chemotherapy are nausea and/or vomiting, diarrhea, fatigue, alopecia, neuropathy, opportunistic infections, and oral mucositis. It is still necessary to establish which microorganisms are predominant in the oral microbiota of children with leukemia, which factors influence it, what is its relationship with oral mucositis and what is their impact in the quality of life. To better understand the risks of secondary infection, it is important to develop preventive and/or therapeutic strategies to control the side effects of antineoplastic treatment in the mouth that may negatively impact the quality of life, to expose the risk of death as well as raise hospital costs for the care of children with leukemia. Objective: To identify the clinical characteristics of the oral condition, types of microorganisms of the oral microbiota, and quality of life in children/adolescents with acute lymphoid leukemia and acute myeloid leukemia before and during antineoplastic treatment, and compare them with healthy children/adolescent individuals. Methodology: Longitudinal, case-control study, with a convenience sample. The study group, composed of children/adolescent individuals who have a definitive diagnosis of acute lymphoid leukemia or acute myeloid leukemia. The control group, non-syndromic children/adolescents, with no history of cancer, matched by age and gender. The clinical condition of the mouth will be evaluated by means of indexes: dental caries index (dmft index), gingival index (GA), and simplified oral hygiene index. The assessment of the quality of life through the ohip-14 and POS-version14 quality of life questionnaire and microbiological evaluation of saliva through MALDI-TOF analysis. Statistical analysis will be performed through relative risk for cohort study with more than three paired groups. Odds ratio, for the control group more than three controlled groups and Mcnemere, for comparison with the control group, for more than three paired groups.

NCT ID: NCT04956042 Terminated - Clinical trials for Refractory Acute Myeloid Leukemia

Study of Fosciclopirox in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Start date: August 27, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This will be an open-label, Phase 1B/2A, study to characterize the efficacy, safety, pharmacokinetics, and pharmacodynamics of fosciclopirox administered alone and in combination with cytarabine in patients with R/R AML with up to two cohorts studied to confirm the efficacy (or futility) of fosciclopirox on the endpoint of disease response. Initially, 14 evaluable patients will be enrolled in Cohort 1a. If disease response to fosciclopirox alone IS observed in at least 4 of 14 patients, an additional 14 patients will be enrolled in Cohort 1b. If disease response to fosciclopirox alone IS NOT observed in at least 4 of 14 patients in Cohort 1a, based on a review of all available study data, the study may be terminated OR a Cohort 2a may be initiated using the combination of fosciclopirox and cytarabine. If disease response to fosciclopirox in combination with cytarabine IS observed in at least 4 of 14 patients in Cohort 2a, an additional 14 patients will be enrolled in Cohort 2b. If disease response to fosciclopirox in combination with cytarabine IS NOT observed in at least 4 of 14 patients in the Cohort 2a, the study will be stopped for futility.

NCT ID: NCT04912063 Terminated - Clinical trials for Acute Myeloid Leukemia (AML)

Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome

Start date: June 25, 2021
Phase: Phase 1
Study type: Interventional

Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo intensive chemotherapy, the current standard of care. This study is to evaluate how safe lemzoparlimab is and how it moves within the body when used along with azacitidine and/or venetoclax in adult participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Adverse events and maximum tolerated dose (MTD) of lemzoparlimab will be assessed. Lemzoparlimab (TJ011133) is being evaluated in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia (AML) and with azacitidine with/without venetoclax for myelodysplastic syndrome (MDS). Study doctors place the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of AML or MDS will be enrolled. Around 80 participants will be enrolled in the study in approximately 50 sites worldwide. Participants will receive lemzoparlimab (IV) once weekly (Q1W), venetoclax oral tablets once daily (QD) for 28 days (AML participants) or 14 days (MDS participants) and Azacitidine by SC or IV route QD for 7 days of each 28-day cycle. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.

NCT ID: NCT04858594 Terminated - Clinical trials for Acute Myeloid Leukemia

Study of Periodontitis and Blood Stream Infection in AML Patients Receiving Chemotherapy

Start date: May 4, 2021
Phase:
Study type: Observational

This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.