Clinical trials: Hypomethylating Agents
Acute Myeloid Leukemia
Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit AML Patients Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96
This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in AML patients unfit for intensive chemotherapy in a "real-life"…
- Trial name
- NCT04589728
- Testing
- Venetoclax plus HMA
- Where
- 23 sites in Italy
- Volunteers
- 202 people
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
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
Myelodysplastic Syndromes, Acute Myeloid Leukemia
Combining Active and Passive DNA Hypomethylation
This is a multicentre, randomized, parallel-group, placebo-controlled, double-blind phase 2 study of the efficacy and safety of oral vitamin C supplement in combination with azacitidine in patients with higher-risk MDS, CMML-2 or…
- Conditions
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
- Trial name
- EVI-3 (NCT03999723)
- Testing
- Vitamin C
- Where
- 10 sites in Denmark, Sweden
- Volunteers
- 196 people
- Sponsor
- Kirsten Grønbæk
Myelodysplastic Syndromes (MDS)
A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS.
- Trial name
- NCT03593915
- Testing
- Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine
- Where
- 12 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sumitomo Pharma America, Inc.
Acute Myeloid Leukemia (AML), Acute Myeloid Leukaemia (AML)
Efficacy of Hypomethylating Agents vs. Intensive Chemotherapy in Acute Myeloid Leukemia Using 5hmC as a Blood-Based Minimal Residual Disease Marker
This is a therapeutic intervention trial evaluating the clinical utility of a novel blood-based epigenetic biomarker-genome-wide 5-hydroxymethylcytosine (5hmC) in cell-free DNA (cfDNA)-for assessing measurable residual disease…
- Trial name
- NCT07060001
- Testing
- 5hmC Biomarker, Venetoclax, Decitabine 20 mg/m²/day for 5 days
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- The Methodist Hospital Research Institute
Myelodysplastic Syndromes
Trial of Volasertib With or Without Azacitidine in Patients With Myelodysplastic Syndromes
The objectives of this trial are to evaluate the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics and preliminary efficacy of volasertib in two dosing schedules of intravenous volasertib as monotherapy or in…
- Trial name
- NCT02721875
- Testing
- Volasertib, Azacitidine
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- Boehringer Ingelheim
Myelodysplastic Syndromes
A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).
This Phase II was a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R…
- Trial name
- STIMULUS-MDS1 (NCT03946670)
- Testing
- MBG453, Hypomethylating agents
- Where
- 48 sites in United States, Austria and 15 more
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
Refractory Chronic Myelomonocytic Leukemia, Refractory Myelodysplastic Syndrome
Fostamatinib for the Treatment of Lower-risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia Who Have Failed Therapy With Hypomethylating Agents
This phase I trial is to find out the best dose, possible benefits and/or side effects of fostamatinib in treating patients with lower-risk myelodysplastic syndromes or chronic myelomonocytic leukemia who have failed therapy with…
- Trial name
- NCT05030675
- Testing
- Fostamatinib
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- M.D. Anderson Cancer Center
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction
This phase II, open-label, randomized trial will compare the efficacy of the novel regimen of cladribine/low-dose cytarabine alternating with decitabine to the current standard of care regimen of hypomethylating agents…
- Trial name
- NCT05766514
- Testing
- Cladribine, Cytarabine, Decitabine
- Where
- United States
- Sponsor
- University of Florida
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Safety and Effectiveness Study of CPI-613 to Treat Refractory or Relapsed Leukemia and Myelodysplastic Syndrome
The purpose of this study is to determine whether CPI-613 is effective and safe in either patients with refractory or relapsed acute myeloid leukemia (AML) or patients with myelodysplastic syndrome (MDS) who have failed therapy…
- Trial name
- NCT01520805
- Testing
- CPI-613
- Where
- United States
- Sponsor
- Cornerstone Pharmaceuticals
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Influence of Molecular Abnormalities on Response of VAH vs. VEN+HMA in RR-AML
The aim of this study is to reveal the influence of gene mutations on the treatment response of the regimen of HHT combined with Venetoclax plus AZA versus venetoclax plus HMA in the salvage therapy of RR-AML.
- Conditions
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Gene Abnormality, Cytogenetic Abnormality
- Trial name
- NCT05456048
- Testing
- VAH regimen, VEN+HMA regimen
- Where
- China
- Volunteers
- 231 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Acute Myeloid Leukemia, Adult, Hypomethylating Agents
Hypomethylating Agents and Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Not Eligible for Intensive Chemotherapy
This is a retrospective, observational, monocentric study to evaluate the efficacy and safety of the combination of an hypomethylating agent with venetoclax newly diagnosed patients with acute myeloid leukemia ineligible for…
- Conditions
- Acute Myeloid Leukemia, Adult, Hypomethylating Agents, Venetoclax
- Trial name
- NCT04454580
- Testing
- Venetoclax
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- Ospedale Maggiore Di Trieste
Acute Myeloid Leukemia
Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents
A treatment cycle is 28 days. Tagraxofusp will be administered at 9 mcg/kg IV over 15 minutes (-5 or +15 minutes) daily for 3 consecutive days (or 3 doses over a period not to exceed 10 days if postponement is required to allow…
- Trial name
- TAGALONG (NCT05442216)
- Testing
- Tagraxofusp, Azacitidine, Venetoclax
- Where
- 7 sites in United States
- Volunteers
- 53 people
- Sponsor
- Joshua Zeidner
Myelodysplastic Syndromes
Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes
Background: Myelodysplastic syndromes (MDS) are diseases that affect the bone marrow. They can inhibit the blood formation process and reduce blood cell counts. High-risk MDS can lead to leukemia.
- Trial name
- NCT05918055
- Testing
- KPT-8602, Inqovi, Bone marrow aspirate
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- National Cancer Institute (NCI)
MDS, CMML
Efficacy and Safety of HMAs Combined With Venetoclax Versus HMAs Alone in ND Int-and H-risk MDS or CMML
The aim of this study is to observe and analyze the clinical efficacy of Venetoclax+HMAs regimen in the treatment of newly diagnosed higher-risk MDS and CMML cases, and to compare the efficacy of venetoclax +HMAs regimen with…
- Trial name
- NCT07318662
- Testing
- Venetoclax
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Guangdong Provincial People's Hospital
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs
A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with…
- Trial name
- NCT02907359
- Testing
- Guadecitabine, Treatment Choice
- Where
- 112 sites in United States, Belgium and 12 more
- Volunteers
- 417 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Carcinoma, Non-Small-Cell Lung, Lung Cancer
Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas
Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Lung cancer is the leading cause of cancer-related death in the United States.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Cancer, Non-Small Cell Lung Cancer, Carcinoma, Esophageal
- Trial name
- NCT03233724
- Testing
- Decitabine (DAC), Tetrahydrouridine (THU), Pembrolizumab
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- National Cancer Institute (NCI)