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Vidaza Medical Research Studies

Up-to-date List of Vidaza 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 Vidaza 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 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
3 Recruiting A Study of Inhaled Vidaza in Advanced Non-Small Cell Lung Lung Cancer Patients
Condition: Non-small Cell Lung Cancer
Intervention: Drug: Inhaled Vidaza
Outcome Measures: Number of patients that will tolerate the treatment with inhalation of Vidaza when given with a nebulizer.;   Number of adverse events when patients are treated with inhaled Vidaza.;   Severity of adverse events when patients are treated with inhaled Vidaza.;   Minimum effective dose of inhaled Vidaza required to induce the re-expression of relevant 5 candidate tumor suppressor genes.
4 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.
5 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).
6 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
7 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
8 Recruiting A Phase I/II Clinical Trial of Vidaza With Abraxane in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer
Conditions: Advanced or Metastatic Solid Tumors;   Advanced or Metastatic Breast Cancer
Interventions: Drug: Azacitidine (Vidaza);   Drug: Nab-paclitaxel (Abraxane)
Outcome Measures: Phase I: To assess safety of Vidaza and Abraxane combination and to select the recommended phase II dose-regimen;   Phase II: To assess clinical efficacy of Vidaza and Abraxane combination;   To explore the relationship between specific biomarkers and cancer- and treatment-related outcomes;;   To assess progression-free survival.
9 Recruiting Randomized Allogeneic Azacitidine Study
Conditions: Leukemia;   AML;   MDS
Intervention: Drug: Azacitidine
Outcome Measure: Relapse-free survival (RFS) Time
10 Recruiting Azacytidine and Lymphocytes in Relapse of AML or MDS After Allogeneic Stem Cell Transplantation.
Conditions: Acute Myelogenous Leukemia;   Myelodysplastic Syndrome
Interventions: Biological: Donor lymphocyte infusion;   Drug: Azacytidine
Outcome Measures: Response rate;   Disease-free survival;   Overall survival;   Toxicity;   Incidence and severity of GvHD;   Incidence and severity of infections
11 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)
12 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.
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 Unknown  Bioequivalence Trial of Luitpold Azacitidine Versus Vidaza® in Patients With Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia or Chronic Lymphocytic Leukemia
Conditions: Myelodysplastic Syndrome;   Myelofibrosis;   Chronic Myeloid Leukemia;   Chronic Lymphocytic Leukemia
Interventions: Drug: Luitpold Azacitidine;   Drug: Vidaza®
Outcome Measures: Area under the Concentration Time Curve (AUC0-t);   Area under the Concentration Time Curve Extrapolated to Infinity (AUC0-∞);   Observed maximal concentration (Cmax)
15 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)
16 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
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 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
19 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
20 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

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

A major focus of Vidaza 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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