Clinical trials: Higher-Risk Myelodysplastic Syndrome
MDS, AML
Non-interventional Study With Azacitidin (Vidaza®)
The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application.
- Conditions
- MDS, AML, CMMOL
- Trial name
- Piaza (NCT01192945)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- iOMEDICO AG
Higher Risk Myelodysplastic Syndromes
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…
- Trial name
- BEXERA (NCT07672769)
- Testing
- bexmarilimab (1mg/kg), azacitidine, bexmarilimab (3mg/kg)
- Where
- 35 sites in United States, Czechia and 5 more
- Volunteers
- 90 people
- Sponsor
- Faron Pharmaceuticals Ltd
Myelodysplastic Syndrome
Study of Tipifarnib in Patients With High-Risk Myelodysplastic Syndrome (MDS)
The purpose of this study is to characterize the hematological response rate, as well as other parameters of efficacy and safety induced by tipifarnib in patients with high-risk myelodysplastic syndrome (MDS).
- Trial name
- NCT00050154
- Testing
- ZARNESTRA, tipifarnib, R115777
- Volunteers
- 82 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Study of ARGX-110 in Combination With Azacytidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)
The purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of…
- Trial name
- NCT03030612
- Testing
- ARGX-110, AZA
- Where
- 7 sites in France, Switzerland
- Volunteers
- 38 people
- Sponsor
- OncoVerity, Inc.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)
The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- NCT02610777
- Testing
- Azacitidine, Pevonedistat
- Where
- 59 sites in United States, Belgium and 10 more
- Volunteers
- 120 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
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
Higher-risk Myelodysplastic Syndromes
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…
- Trial name
- NCT06196203
- Testing
- AK117, Azacitidine
- Where
- 15 sites in United States, China
- Volunteers
- 90 people
- Sponsor
- Akeso
Myelodysplastic Syndrome
Efficacy and Safety of ON 01910.Na in Myelodysplastic Syndrome (MDS) Patients With Trisomy 8 or Classified as Intermediate-1, -2 or High Risk
This study will explore the efficacy and safety of a regimen of ON 01910.Na as a 48-hour continuous intravenous infusion once a week for 3 weeks of a 4-week cycle in MDS patients with Trisomy 8 or classified as Intermediate-1, -2…
- Trial name
- NCT00906334
- Testing
- ON 01910.Na
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Traws Pharma, Inc.
Leukaemia
First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome
Primary Objective: Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in participants with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic…
- Trial name
- NCT03594955
- Testing
- SAR440234
- Where
- 4 sites in United States, France
- Volunteers
- 7 people
- Sponsor
- Sanofi
Relapsed or Refractory Haematological Malignancies Including, Acute Myeloid Leukemia
Study to Assess Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity of AZD4573 in subjects with relapsed or refractory haematological malignancies.
- Conditions
- Relapsed or Refractory Haematological Malignancies Including, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia
- Trial name
- NCT03263637
- Testing
- AZD4573
- Where
- 12 sites in Germany, Netherlands and 1 more
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Hematologic Malignancy, Acute Myeloid Leukemia
CD123-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies
Phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD123-CD33 cCAR in patients with relapsed and/or refractory, high risk hematologic malignancies.
- Conditions
- Hematologic Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasm
- Trial name
- NCT04156256
- Testing
- CD123-CD33 cCAR T cells
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Acute Myeloid Leukemia, Myelodysplastic Syndromes
PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)
CPKC412A2104 core had a 2 stage design. In stage 1, eight participants were treated. If at least one participant showed a clinical response, four more participants were recruited to stage 2.
- Trial name
- NCT00045942
- Testing
- Itraconazole, PKC412
- Where
- 4 sites in United States
- Volunteers
- 144 people
- Sponsor
- Novartis Pharmaceuticals
Myelodysplastic Syndrome, Myelodysplastic Syndromes
Safety, Clinical Activity, Pharmacokinetics (PK) and Pharmacodynamics Study of GSK2879552, Alone or With Azacitidine, in Subjects With High Risk Myelodysplastic Syndromes (MDS)
This is a Phase I/II, open-label, 2 arm study to evaluate the safety and clinical activity of GSK2879552 alone, or in combination with azacitidine in subjects with MDS. The study consisted of 2 parts.
- Trial name
- NCT02929498
- Testing
- GSK2879552, Azacitidine
- Where
- 6 sites in United States, Spain
- Volunteers
- 7 people
- Sponsor
- GlaxoSmithKline
Myelodysplastic Syndrome, Acute Myelogenous Leukemia
A Phase I/II Study of MGCD0103 With Azacitidine in Patients With High-Risk Myelodysplastic Syndrome (MDS) or Acute Myelogenous Leukemia
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly in combination with azacitidine to patients with high-risk myelodysplastic syndromes or acute myelogenous leukemia.
- Trial name
- NCT00324220
- Testing
- MGCD0103
- Where
- 8 sites in United States
- Volunteers
- 66 people
- Sponsor
- Mirati Therapeutics 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, 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
Myelodysplastic Syndromes
Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)
The primary purpose of this study is to determine the effectiveness and safety of azacitidine in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).
- Trial name
- NCT01201811
- Testing
- Azacitidine
- Where
- 11 sites in Taiwan
- Volunteers
- 44 people
- Sponsor
- Celgene
Myelodysplastic Syndromes
Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes
Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason…
- Trial name
- NCT02281084
- Testing
- Oral Azacitidine, Durvalumab
- Where
- 89 sites in United States, Australia and 8 more
- Volunteers
- 65 people
- Sponsor
- Celgene
Myelodysplastic Syndromes
A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes
This is a Phase 2, two-stage study of the safety and efficacy of pracinostat in combination with azacitidine in patients with IPSS-R high and very high risk myelodysplastic syndrome (MDS) who are previously untreated with…
- Trial name
- NCT03151304
- Testing
- Pracinostat, Azacitidine
- Where
- 25 sites in United States
- Volunteers
- 64 people
- Sponsor
- Helsinn Healthcare SA
Acute Myeloid Leukemia, Myelodysplastic Syndrome
A Study of Bomedemstat (IMG-7289/MK-3543) With and Without ATRA, in Participants With Advanced Myeloid Malignancies (IMG-7289-CTP-101/MK-3543-001)
This is an open label study of the dose and duration of an orally administered lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat, in patients with high-risk acute myeloid leukemia (AML) and high-risk myelodysplastic…
- Trial name
- NCT02842827
- Testing
- bomedemstat, tretinoin
- Where
- Australia
- Volunteers
- 45 people
- Sponsor
- Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)