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Azacitidine Medical Research Studies

Up-to-date List of Azacitidine Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Azacitidine Medical Research Studies

Rank Status Study
1 Recruiting A Study Being Conducted at Multiple Locations to Compare the Safety and Effectiveness of Three Different Treatment Regimens; 1) Lenalidomide, 2) Lenalidomide + Azacitidine, or 3) Azacitidine Alone in Newly Diagnosed Acute Myeloid Leukemia in Elderly Subjects ≥ 65 Years of Age
Conditions: Acute Myeloid Leukemia;   Acute Myelogenous Leukemia
Interventions: Drug: Azacitidine-single agent;   Drug: Lenalidomide - single agent;   Drug: Lenalidomide in combination with Azacitidine
Outcome Measures: Survival;   Remission Rate;   Remission Duration;   Cytogenetic Complete Remission Rate;   Overall Response Rate;   Progression-free survival;   Event-free survival;   Relapse-free survival;   30-day treatment-related mortality;   Safety and Tolerability
2 Not yet recruiting Azacitidine Plus Deferasirox (ICL670) in Higher Risk Myelodysplastic Syndromes (MDS)
Condition: Myelodysplastic Syndromes
Interventions: Drug: Deferasirox + Azacitidine;   Drug: Azacitidine
Outcome Measures: Difference in proportion of patients with hematologic improvement as defined by the IWG criteria30 with the addition of deferasirox to Azacitidine compared with Azacitidine alone in higher risk non-responding MDS patients after 6 cycles of Azacitidine.;   Tolerability (defined by the percentage of patients able to remain on deferasirox for 6 cycles concurrent with Azacitidine) and safety (type, using CTCAE version 4.0, frequency, severity, and relationship of adverse events to study therapy);   Percentage and absolute change in serum ferritin and labile plasma iron (LPI) between baseline and end of study;   Percentage change in CD34 cell intracellular reactive oxygen species (ROS) from baseline to end of study.;   Percentage change in erythroid colony forming units (BFU-E and CFU-E) from baseline to end of study;   Percentage change in markers of DNA damage (lipid peroxidation, GSH content, and gH2AX expression), and activity of NFkappaB and Akt signaling pathways between baseline and end of study.
3 Recruiting The Efficacy of Azacitidine +/- Lenalidomide in High-risk Myelodysplastic Syndrome (MDS)and Acute Myeloid Leukemia (AML) With Del(5q).
Conditions: Myelodysplastic Syndrome;   Acute Myelogenous Leukemia
Interventions: Drug: Azacitidine;   Drug: Azacitidine + lenalidomide
Outcome Measures: Response according to IWG criteria for MDS and AML;   Cytogenetic response after 3 cycles using Fluorescence In Situ Hybridization(FISH);   Safety (number and types of adverse advents) in Azacitidine vs Azacitidine + lenalidomide groups;   Azacitidine cycle interval between groups;   Survival in Azacitidine vs Azacitidine + lenalidomide groups;   Relapse in Azacitidine vs Azacitidine + lenalidomide groups;   Analysis of a broad spectrum of molecular and cellular events which previously have been identified as related to MDS with del(5q).
4 Recruiting Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) in Combination With Azacitidine for the Treatment of Myelodysplastic Syndrome (MDS)
Condition: Myelodysplastic Syndromes
Interventions: Drug: G-CSF;   Drug: Plerixafor;   Drug: Azacitidine
Outcome Measures: Determine the optimal dose and schedule of plerixafor + G-CSF and Azacitidine in patients with MDS;   Determine the safety and tolerability of plerixafor + G-CSF and Azacitidine;   Characterize the mobilization of MDS cells;   Determine the pharmacokinetics of plerixafor on Azacitidine;   Determine progression free survival and response rates;   Freedom from transfusion
5 Recruiting Phase I/II - Brentuximab/5-Azacytidine in Acute Myeloid Leukemia (AML)
Condition: Leukemia
Interventions: Drug: Brentuximab Vedotin;   Drug: 5-Azacytidine
Outcome Measures: Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination with 5-Azacytidine;   Overall Response Rate
6 Recruiting Azacitidine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With High-Risk Acute Myeloid Leukemia
Conditions: Adult Acute Megakaryoblastic Leukemia (M7);   Adult Acute Monoblastic Leukemia (M5a);   Adult Acute Monocytic Leukemia (M5b);   Adult Acute Myeloblastic Leukemia With Maturation (M2);   Adult Acute Myeloblastic Leukemia Without Maturation (M1);   Adult Acute Myeloid Leukemia in Remission;   Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;   Adult Acute Myeloid Leukemia With Del(5q);   Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);   Adult Acute Myeloid Leukemia With t(16;16)(p13;q22);   Adult Acute Myeloid Leukemia With t(8;21)(q22;q22);   Adult Acute Myelomonocytic Leukemia (M4);   Adult Erythroleukemia (M6a);   Adult Pure Erythroid Leukemia (M6b);   Recurrent Adult Acute Myeloid Leukemia;   Secondary Acute Myeloid Leukemia;   Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: Azacitidine;   Drug: cytarabine;   Drug: mitoxantrone hydrochloride;   Other: laboratory biomarker analysis
Outcome Measures: Recommended phase II dose of Azacitidine when combined with high-dose cytarabine and mitoxantrone hydrochloride, based on incidence of dose limiting toxicity (DLT) graded according to the National Cancer Institute Common Toxicity Criteria, version 4;   Change in gene expression levels of topoisomerase II and deoxycytidine kinase in leukemic blasts pre-treatment and following therapy with Azacitidine will be measured by real-time polymerase chain reaction (RT-PCR)
7 Recruiting Midostaurin and Azacitidine in Treating Elderly Patients With Acute Myelogenous Leukemia
Conditions: Hematopoietic/Lymphoid Cancer;   Chronic Myelomonocytic Leukemia;   de Novo Myelodysplastic Syndromes;   Myelodysplastic Syndromes;   Recurrent Adult Acute Myeloid Leukemia;   Secondary Myelodysplastic Syndromes;   Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: midostaurin;   Drug: Azacitidine;   Other: laboratory biomarker analysis;   Other: bone marrow aspiration;   Other: liquid chromatography;   Other: flow cytometry;   Other: mutation analysis;   Other: pharmacological study;   Other: mass spectrometry;   Other: protein expression analysis
Outcome Measures: Maximum tolerated dose of midostaurin in combination with Azacitidine in patients with acute myelogenous leukemia (Phase I);   Rate of hematologic improvement;   Complete and partial response rate of midostaurin and Azacitidine in untreated acute myelogenous leukemia (Phase I/II);   Pharmacokinetic profile of midostaurin given with Azacitidine (Phase I);   Time to disease progression;   Changes of phosphorylation status of FLT3 in blood and bone marrow samples (Phase I/II);   Overall survival (Phase I/II);   To correlate treatment response with FLT3 mutational status in a descriptive fashion.(Phase I)
8 Recruiting Randomized Allogeneic Azacitidine Study
Conditions: Leukemia;   AML;   MDS
Intervention: Drug: Azacitidine
Outcome Measure: Relapse-free survival (RFS) Time
9 Recruiting A Trial of Oral 5-Azacitidine in Combination With Romidepsin in Advanced Solid Tumors, With an Expansion Cohort in Non-small Cell Lung Cancer
Conditions: Solid Tumors;   Non-small Cell Lung Cancer
Intervention: Drug: oral 5-Azacitidine in combination with romidepsin
Outcome Measures: Incidence of adverse events;   Maximum Tolerated Dose (MTD);   Clinical responses associated with oral 5-Azacitidine and romidepsin;   Peak plasma concentration (Cmax);   Determine whether changes in DNA methylation, histone acetylation, and/or gene expression correlates with clinical response to oral 5-Azacitidine and romidepsin
10 Recruiting VIDAZA-DLI Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome
Conditions: Acute Myeloid Leukemia;   Myelodysplastic Syndrome
Interventions: Drug: Azacitidine;   Other: DLI
Outcome Measures: Evaluation of the cumulative incidence of relapse rate;   Evaluation of disease-free survival (DFS) at 2 years from transplantation;   Measure the overall survival rate at 2 years;   Cumulative incidence death from leukemia, and non relapse mortality (NRM);   Feasibility and safety of administrating maintenance Azacitidine following allogenic transplantaton;   Feasibility and safety of performing prophylactic donor lymphocytes infusion;   Incidence and severity of acute and chronic graft-versus-host disease
11 Recruiting Vosaroxin and Azacitidine in Treating Patients With Myelodysplastic Syndromes
Condition: Myelodysplastic Syndromes
Interventions: Drug: vosaroxin;   Drug: Azacitidine
Outcome Measures: MTD of vosaroxin in combination with Azacitidine;   Best response (including hematologic improvement);   Best overall response;   Incidence of adverse events;   Time to response;   Event-free survival;   Progression-free survival (PFS);   Disease-free survival (DFS);   Overall survival (OS);   Biomarkers of response to vosaroxin and Azacitidine therapy
12 Recruiting Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk
Condition: Leukemia
Interventions: Drug: Decitabine;   Drug: Azacitidine
Outcome Measures: Overall Improvement Rate (OIR);   Transfusion Independence
13 Recruiting Best Promising Drug Association With Azacitidine in Higher Risk Myelodysplastic Syndromes
Condition: MDS
Interventions: Drug: Azacitidine;   Drug: Azacitidine associated with Valproic acid;   Drug: Azacitidine associated with Lenalidomide
Outcome Measures: Remission, complete, partial or medullary after 6 cycles;   Stable disease with hematological improvement;   Duration of response;   Progression to acute myeloid leukemia;   Overall survival;   Number of adverse events
14 Recruiting A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML
Conditions: Lymphoblastic Leukemia, Acute, Childhood;   Myelogenous Leukemia, Acute, Childhood
Interventions: Drug: Azacitidine;   Drug: Fludarabine;   Drug: Cytarabine
Outcome Measures: The dose of azacytidine that can be given safely with fludarabine and cytarabine.;   The response rate after treatment.;   DNA methylation and gene expression before and after treatment with azacytidine.
15 Not yet recruiting A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)
Condition: Thrombocytopaenia
Interventions: Drug: Eltrombopag;   Drug: Azacitidine;   Drug: Placebo
Outcome Measures: Cycle 1-4 platelet transfusion independence (The proportion of subjects who are platelet transfusion free during Cycles 1-4 of Azacitidine therapy);   Overall survival (OS);   Disease Response;   Duration of Disease Response;   Progression Free Survival;   Time to Progression;   Proportion of subjects that progress to Acute Myeloid Leukemia (AML);   Time to AML progression;   Hematologic improvement (HI) in platelets, neutrophils, and hemoglobin;   Duration of HI of platelets, neutrophils and hemoglobin;   Number of platelet and Red Blood Cells (RBC) transfusions;   Duration of platelet and RBC transfusion independence;   Bleeding adverse events (AEs) >= Grade 3;   Azacitidine dose delays and dose reductions;   Evaluation of Adverse event reporting (including bleeding and transfusion-related adverse events) and clinical laboratory tests;   Changes from baseline in all domains of Euroquol-5 Dimensions of Health, 3 Response Levels (EQ-5D-3L™);   Changes from baseline in all domains of Functional Assessment of Chronic Disease Therapy-fatigue subscale (FACIT-Fatigue);   Changes from baseline in all domains of European Organization for Research and Treatment of Cancer - Quality of Life questionnaire - 30 item (EORTC QLQ-C30);   Changes from baseline in all domains of independent questions regarding the value of transfusion independence;   Medical resource utilization (MRU): Event and use of site specific medical resources;   Pharmacokinetics: Evaluation of covariates, and estimates of between and within subject variability
16 Recruiting Randomised Study of Azacitidine Versus Azacitidine in Combination With Vorinostat in Patients With Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndromes
Condition: Leukemia, Myeloid, Acute
Interventions: Drug: Azacitidine;   Drug: Vorinostat
Outcome Measures: Phase II - Overall Response Rate;   Phase II - Overall Survival;   Phase II - Toxicities measured by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE);   Phase II - Complete Remission (CR) within 6 cycles of treatment;   Phase II - Duration of response;   Phase II - Dose intensity;   Phase II - Quality of Life measured by questionnaires;   Phase II - Medical Resource Use
17 Recruiting Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS
Condition: Myelodysplastic Syndrome
Interventions: Drug: Mocetinostat;   Drug: Azacitidine
Outcome Measures: Number of subjects with adverse events, including pericardial events, as a measure of safety;   Number of subjects experiencing clinical disease response
18 Recruiting Oral Rigosertib in Combination With Azacitidine
Conditions: Myelodysplastic Syndrome;   Acute Myeloid Leukemia;   Chronic Myelomonocytic Leukemia
Interventions: Drug: oral rigosertib;   Drug: Azacitidine
Outcome Measures: Dose escalation part of study: Number of patients in whom Dose a Limiting Toxicity (DLT) are observed;   Dose escalation part of study: Number of patients in whom adverse events are observed;   In Phase 2 of study: Number of patients in whom adverse events are observed;   In Phase 2 of study: Area Under the Curve (AUC);   In Phase 2 of the study: Cmax;   Number of patients with complete or partial response;   Number of patients in whom improvements in absolute neutrophil count, platelet count, and erythroid responses are observed
19 Recruiting Addition of Vorinostat to Azacitidine in Higher Risk MDS a Phase II add-on Study in Patients With Azacitidine Failure
Condition: Myelodysplastic Syndrome
Intervention: Drug: Azacitidine and oral vorinostat
Outcome Measure: Response rate
20 Recruiting Azacitidine and Lenalidomide for Acute Myeloid Leukemia
Condition: Leukemia, Myeloid, Acute
Interventions: Drug: Lenalidomide;   Drug: Azacitidine
Outcome Measures: Phase I only - dose limiting toxicities and the maximum tolerated dose of the combination of lenalidomide and Azacitidine;   Phase II only - complete remission rate after lenalidomide and Azacitidine therapy;   Response rate;   Morphologic leukemia-free state;   Morphologic complete remission rate (CRm);   Cytogenetic CR (CRc) rate;   CR with incomplete blood counts rate;   Partial remission rate (PR);   Duration of response;   Overall survival and event free survival;   Toxicity profile;   Expression levels of cytokines/chemokines in the bone marrow plasma, expression of chemokine receptors/ligands on leukemic blasts, and direct cytotoxic effects of lenalidomide, Azacitidine, and combination of both drugs on cryopreserved AML blast cells

These studies may lead to new treatments and are adding insight into Azacitidine etiology and treatment.

A major focus of Azacitidine research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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