Clinical trials: Higher-risk Myelodysplastic Syndromes
AML
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the…
- Trial name
- VOYAGE (NCT02152956)
- Testing
- Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
- Where
- 43 sites in United States, France and 6 more
- Volunteers
- 244 people
- Sponsor
- MacroGenics
Myelodysplastic Syndrome (MDS)
Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome
Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells.
- Trial name
- Verona (NCT04401748)
- Testing
- Venetoclax, Azacitidine
- Where
- 220 sites in United States, Australia and 21 more
- Volunteers
- 531 people
- Sponsor
- AbbVie
Myelodysplastic Syndrome
Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome
The purpose of this randomized, double-blind, placebo-controlled study is to determine the safety and efficacy of pracinostat compared to placebo when combined with azacitidine, and FDA approved treatment for Myelodysplastic…
- Trial name
- NCT01873703
- Testing
- pracinostat, Azacitidine
- Where
- 24 sites in United States
- Volunteers
- 102 people
- Sponsor
- Helsinn Healthcare SA
Myelodysplastic Syndrome (MDS)
Study of Azacitidine to Evaluate Safety and Effectiveness for Chinese Patients With Higher Risk Myelodysplastic Syndrome
The purpose of the study is to determine whether azacitidine is safe and effective in the treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).
- Trial name
- NCT01599325
- Testing
- Azacitidine
- Where
- 11 sites in China
- Volunteers
- 72 people
- Sponsor
- Celgene
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic (MD) Syndrome With Laromustine and Infusional Cytarabine
The purpose of the Phase I portion of this study is to evaluate the safety of this combination of medications and to determine the appropriate dose of VNP40101M to be used in combination with infusional cytarabine (araC) in…
- Trial name
- NCT00655395
- Testing
- Laromustine (VNP40101M) and Ara-C
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Viron Therapeutics Inc
Myelodysplastic Syndrome
Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS
This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk…
- Trial name
- NCT02706899
- Testing
- vadastuximab talirine, Azacitidine
- Where
- 34 sites in United States
- Volunteers
- 19 people
- Sponsor
- Seagen Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome.
Master Protocol: The main goal of this master clinical trial study is to assesses the safety, tolerability, pharmacokinetic (PK), Pharmacodynamic (PD) in participants with relapsed or refractory acute myeloid leukemia (AML) or…
- Trial name
- NCT05457010
- Testing
- SPRX002, ARC-T Cells, Cyclophosphamide
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Kite, A Gilead Company
AML, Adult, MDS
Phase 2, Open-Label, Single Arm Study, With BST-236 in Adults With R/R AML or Higher-Risk MDS
An open label multi center study to assess the safety and efficacy of BST-236 as single agent in adult patients unfit for standard therapy with Acute Myeloid Leukemia (AML) or higher-risk (HR) Myelodysplastic Syndromes (MDS) who…
- Conditions
- AML, Adult, MDS, Relapse/Recurrence, Refractory Acute Myeloid Leukemia
- Trial name
- NCT04749355
- Testing
- BST-236
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- BioSight Ltd.
Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic
Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine.
- Conditions
- Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- PANTHER (NCT03268954)
- Testing
- Azacitidine, Pevonedistat
- Where
- 242 sites in United States, Australia and 18 more
- Volunteers
- 454 people
- Sponsor
- Takeda
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome
A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)
The purpose of this study was to evaluate the safety and tolerability and to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of ASP7517.
- Trial name
- NCT04079296
- Testing
- ASP7517
- Where
- 16 sites in United States, Japan
- Volunteers
- 43 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Myelodysplastic Syndromes
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.
- Trial name
- NCT01011283
- Testing
- decitabine, azacitidine
- Where
- 19 sites in United States
- Volunteers
- 26 people
- Sponsor
- Eisai Inc.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
A Study of Azacitidine in Participants With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
The purpose of this study is to assess the safety and effectiveness in the real-world setting among participants who are treated with Azacitidine in accordance with the China Product Label.
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- DIM Vidaza (NCT05218902)
- Where
- China
- Volunteers
- 290 people
- Sponsor
- Bristol-Myers Squibb
Myelodysplastic Syndromes
A Study to Investigate the Efficacy and Safety of Roxadustat (FG-4592) for Treating Anemia in Participants With Myelodysplastic Syndromes (MDS)
The study is designed to determine the efficacy and safety of roxadustat for the treatment of anemia due to very low, low, or intermediate risk MDS in participants with high transfusion burden (HTB).
- Trial name
- NCT07722988
- Testing
- Roxadustat
- Volunteers
- 201 people
- Sponsor
- Kyntra Bio
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
The purpose of the study is to determine how effective azacitidine, MGCD0103, and the combination of azacitidine and MGCD0103 are in treating AML or MDS in people over 60 years of age.
- Trial name
- NCT00666497
- Testing
- Azacitidine, MGCD0103
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 6 people
- Sponsor
- Mirati Therapeutics Inc.
High Risk MDS
Phase II Study to Evaluate Overall Response in Patients With Higher Risk Myelodysplastic Syndromes (MDS) Treated With Azacitidine With or Without Deferasirox.
The primary objective of the study is to compare the overall response rate (inclusive of complete response, partial response and hematologic improvement) per IWG 2006 criteria in patients with higher risk MDS treated with…
- Trial name
- NCT02159040
- Testing
- Azacitidine, Azacitidine plus Deferasirox
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndrome (MDS)
A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes
An open label, Phase 1, study of AMV564 as monotherapy to assess the safety and efficacy in patients with Myelodysplastic Syndromes
- Trial name
- NCT03516591
- Testing
- AMV564 14-Day CIV
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Amphivena Therapeutics, Inc.
AML, Adult Recurrent, MDS
A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)
A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/refractory, High-risk…
- Trial name
- NCT05829226
- Testing
- LYT-200, Venetoclax, Azacitidine
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- PureTech
Leukemia, Leukemia, Myeloid
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome…
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Preleukemia
- Trial name
- NCT06501196
- Testing
- BH-30236, Venetoclax
- Where
- 13 sites in United States
- Volunteers
- 170 people
- Sponsor
- BlossomHill Therapeutics
Myelodysplastic Syndrome (MDS)
A Study of BLEX 404 Oral Liquid in Patients With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-Risk Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML)
This is a clinical trial to determine the safety, recommended dose level (RDL), and infection control of BLEX 404 Oral Liquid in combination with azacitidine in patients with International Prognostic Scoring System (IPSS)…
- Trial name
- NCT02944955
- Testing
- BLEX 404 Oral Liquid
- Volunteers
- 52 people
- Sponsor
- BioLite, Inc.
Myelodysplastic Syndromes, Acute Myeloid Leukemia
A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants
This study is to determine the safety and preliminary efficacy of sabatolimab in combination with magrolimab and azacitidine in adult participants with 1L unfit Acute Myeloid Leukemia (AML) or with 1L higher risk Myelodysplastic…
- Trial name
- NCT05367401
- Testing
- Sabatolimab, Magrolimab, Azacitidine
- Sponsor
- Novartis Pharmaceuticals