Higher Risk Myelodysplastic Syndromes

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Review clinical trials related to Higher Risk Myelodysplastic Syndromes. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Bexmarilimab + Azacitidine Versus Placebo + Azacitidine in Participants With Treatment-naïve Higher-risk Myelodysplastic Syndromes

This Phase IIb study (BEXERA) will evaluate the safety and efficacy of bexmarilimab (FP-1305), an antibody targeting Clever-1, given in combination with azacitidine compared with azacitidine plus placebo in adults with treatment-naïve higher-risk myelodysplastic syndromes (HR-MDS). Participants will be randomized to receive bexmarilimab at one of two dose levels (1 mg/kg or 3 mg/kg) plus azacitidine, or placebo plus azacitidine. The primary aim is to select the recommended dose of bexmarilimab for subsequent development based on a predefined integration of clinical response and safety/tolerability.

Participants needed: 90
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Faron Pharmaceuticals LtdUpdated: Jun 29, 2026
Eligibility criteria

Participant provides written informed consent. [+11]

Participant has a previous diagnosis of AML, has transformed to AML, or has MDS... [+18]

Status: Recruiting

Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression

The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.

Participants needed: 84
Trial details
Phase: Phase 1, Phase 2Age: 16+Biological sex: AllType: InterventionalSponsor: AstraZenecaUpdated: Jun 17, 2026Locations: 30
Eligibility criteria

Adequate organ function. [+4]

Participants with Burkitt lymphoma/leukaemia or Acute Promyelocytic Leukaemia. [+8]

Status: Recruiting

Study of REM-422 in Patients With AML or Higher Risk MDS

The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML

Participants needed: 100
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Remix TherapeuticsUpdated: Apr 23, 2025Locations: 9
Eligibility criteria

Be able to provide informed consent. [+13]

Active central nervous system (CNS) leukemia or a confirmed diagnosis of CNS leu... [+22]

Status: Recruiting

A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).

Participants needed: 90
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: AkesoUpdated: Feb 11, 2025Locations: 15
Eligibility criteria

Age ≥ 18 years old at the time of enrolment. [+8]

MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), myelodysplas... [+9]

Status: Recruiting

VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS

The goal of this phase 1/2 trial is to test the safety and efficacy of Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT in treating patients with higher-risk MDS.

Participants needed: 54
Trial details
Phase: Phase 1, Phase 2Age: 70+Biological sex: AllType: InterventionalSponsor: Navy General Hospital, BeijingUpdated: Oct 1, 2024Locations: 1
Eligibility criteria

The patient should, in the investigator's opinion, be able to meet all clinical... [+2]

Active or uncontrolled infections requiring systemic treatment within 14 days be... [+1]