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AML clinical trials

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NCT ID: NCT05063123 Withdrawn - AML Clinical Trials

Study to Assess an Interphase Cycle With Flotetuzumab.

HOVON162AML
Start date: January 2022
Phase: Phase 2
Study type: Interventional

Patients who have measurable residual disease (MRDpos, defined as MRD > 0.1% by flowcytometry or detectable mutant Nucleophosmin 1 (NPM1) by quantitative polymerase chain reaction (qPCR) after two cycles of intensive chemotherapy) prior to start conditioning for an allogeneic Hematopoietic Cell Transplantation (HCT) have a very high risk of relapse after transplantation. Important questions in the field are whether patients with MRD after intensive chemotherapy can be converted to MRD negativity (i.e. undetectable MRD, MRDneg) and whether this conversion impacts on the relapse rate after transplantation. This trial aims to develop effective "interphase" treatment for patients in morphological complete remission (CR) with MRD after at least 2 cycles of intensive chemotherapy and prior to start conditioning for an allogeneic HCT. Flotetuzumab, a bispecific antibody-based molecule against CD3 and CD123 in a dual-affinity re-targeting antibody (DART®) format is a new treatment modality based on immunomodulation. The rationale to use flotetuzumab in this study is: 1) its antileukemic activity reported in R/R AML; 2) its limited extra-medullary (i.e. tissue) toxicity; and 3) its short halflife.

NCT ID: NCT04973618 Withdrawn - AML Clinical Trials

Study of APVO436 in Elderly or Unfit Patients With Newly Diagnosed AML

Start date: January 2025
Phase: Phase 1
Study type: Interventional

The goal of this Phase IB study is to evaluate the safety and tolerability of APVO436 in naïve elderly unfit patients with newly diagnosed primary AML at the RP2D level when it is used as an adjunct to the standard of care and obtain a preliminary assessment of the anti-leukemia activity of an APVO436-containing combination therapy. Study Objectives: - Primary Objective: Evaluate the safety and tolerability of APVO436 at the RP2D level when it is used as an adjunct to the standard of care (venetoclax and azacitidine). - Secondary Objectives: - Obtain a preliminary assessment of the anti-leukemia activity of APVO436-containing experimental triple drug combination therapy modalities. - Determine pharmacodynamics (PD) of APVO436, including changes in CD123 antigen density and measures of T cell number and function over time. - Determine correlations between response and MRD level and cytogenetic and molecular genetic profiles.

NCT ID: NCT04530695 Withdrawn - Clinical trials for Acute Myelogenous Leukemia

Diagnosis and Treatment of Periodontal Disease in Patients With AML

Start date: May 2022
Phase: N/A
Study type: Interventional

This is a phase 2 randomized controlled trial of pre-chemotherapy periodontal deep cleaning in Acute Myelogenous Leukemia (AML) patients with asymptomatic periodontitis. Once eligibility is confirmed, participants with periodontitis will be randomized in a 1:1 ratio to undergo treatment by scaling and root planing (SRP, "deep cleaning") (arm A) or receive no periodontal treatment (arm B). We will compare the incidence of Blood Stream Infection (BSI) during chemotherapy between the two arms. Study participation will continue until day 28 of chemotherapy or discharge from hospital, whichever occurs first.

NCT ID: NCT04128020 Withdrawn - Aml Clinical Trials

Azacitidine Plus Nivolumab Following Reduced-intensity Allogeneic PBSC Transplantation for Patients With AML and High-risk Myelodysplasia

Start date: October 10, 2019
Phase: Phase 1
Study type: Interventional

This is a phase I clinical trial that will define the maximum tolerated dose (MTD) and investigate the feasibility and safety of the combination of nivolumab and azacitidine after reduced-intensity allogeneic PBSC transplantation. Dose escalation will follow a traditional 3+3 design. The investigators will first escalate the dose of single agent nivolumab to determine its MTD (if any, at the doses tested), with an expanded cohort at the MTD or highest dose tested. The investigators will then combine escalating azacitidine in combination of with nivolumab at its determined MTD or highest dose tested in earlier cohorts, and expand the highest dose cohort tested with the combination. Patients will be treated according to the dose level cohorts described in the protocol.

NCT ID: NCT03491579 Withdrawn - AML Clinical Trials

Epacadostat, Cladribine and Cytarabine (ECC) in AML

ECC
Start date: December 2018
Phase: Phase 1
Study type: Interventional

This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the cladribine/cytarabine chemotherapy in relapsed / refractory AML patients fit for intensive treatment

NCT ID: NCT03444649 Withdrawn - AML Clinical Trials

Epacadostat, Idarubicin and Cytarabine (EIC) in AML

EIC
Start date: September 2018
Phase: Phase 1
Study type: Interventional

This trial assess the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLTs) of epacadostat when added to the anthracycline/cytarabine combination as first-line induction treatment in AML patients fit for intensive treatment

NCT ID: NCT03138395 Withdrawn - Clinical trials for Myelodysplastic Syndromes

iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML

iCare3
Start date: September 15, 2017
Phase: N/A
Study type: Observational

This study will use droplet digital PCR (ddPCR) method to quantify and track peripheral blood plasma mutant allele frequency (MAF) in MDS and AML patients before, during and after chemotherapy treatment. Quantification of MAF from fingersticks and saliva samples will also be performed to determine feasibility of obtaining adequate circulating tumor DNA (ctDNA) for ddPCR.

NCT ID: NCT02905994 Withdrawn - AML Clinical Trials

Volasertib Combined With Induction Chemotherapy in Acute Myeloid Leukemia

Start date: September 2016
Phase: Phase 1
Study type: Interventional

The study intervention involved in this study is the addition of a dose of volasertib as a part of the initial chemotherapy regimen for AML. The trial will involve a combination of the following drugs: - Volasertib (the study drug) - Idarubicin - Cytarabine