VIDAZA SUMMARY
Vidaza™ (azacitidine for injectable suspension) contains azacitidine, which is a pyrimidine nucleoside analog of cytidine. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1 H)-one.
Vidaza is indicated for treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
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NEWS HIGHLIGHTS
Published Studies Related to Vidaza (Azacitidine Subcutaneous)
Thrice weekly azacitidine does not improve hematological responses in lower-risk myelodysplastic syndromes: a study of the Hoosier Oncology Group. [2011.08]
Prolonged administration of methyl transferase inhibitors may increase response rates in myelodysplastic syndromes (MDS). Fourteen MDS patients with anemia and less than 10% marrow blasts received azacitidine 50 mg/m(2) thrice weekly for 2 weeks every 4 weeks; 7 also received weekly erythropoietin...
Effects of azacitidine compared with conventional care regimens in elderly (>/= 75 years) patients with higher-risk myelodysplastic syndromes. [2010.12]
This analysis compared azacitidine (AZA) to conventional care regimens (CCR) and their associated overall survival (OS) and tolerability in the subset of 87 elderly (>/= 75 years) patients with higher-risk MDS (FAB: RAEB, RAEB-t, CMML and IPSS: Int-2 or High) from the AZA-001 trial... Given this efficacy and tolerability, AZA should be considered the treatment of choice in patients aged >/= 75 years with good performance status and higher-risk MDS.
Phase 2 study of romiplostim in patients with low- or intermediate-risk myelodysplastic syndrome receiving azacitidine therapy. [2010.10.28]
We evaluated the efficacy and safety of romiplostim, a thrombopoietin mimetic, in patients with low- or intermediate-risk myelodysplastic syndromes (MDS) receiving azacitidine therapy. Forty patients with low- or intermediate-risk MDS were stratified by baseline platelet counts (< 50 vs >/= 50 x 10(9)/L) and randomized to romiplostim 500 mug or 750 mug or placebo subcutaneously once weekly during 4 cycles of azacitidine...
Management and supportive care measures for adverse events in patients with myelodysplastic syndromes treated with azacitidine*. [2010.08]
OBJECTIVE: Myelodysplastic syndrome (MDS) treatment can initially worsen patients' clinical condition and they may discontinue therapy before achieving benefit. We present previously unpublished data from two large phase III trials describing common adverse events (AEs) associated with azacitidine and methods to manage them... CONCLUSION: Hematologic and non-hematologic AEs with azacitidine decreased in frequency as treatment continued. Awareness of the onset, duration and management of AEs can facilitate treatment, permitting patients to continue therapy for maximum benefit.
Prolonged survival with improved tolerability in higher-risk myelodysplastic syndromes: azacitidine compared with low dose ara-C. [2010.04]
In the phase III AZA-001 trial, low-dose cytarabine (LDara-C), the most widely used low-dose chemotherapy in patients with higher-risk myelodysplastic syndrome (MDS) who are ineligible for intensive treatment, was found to be associated with poorer survival compared with azacitidine... When analyzed per patient year of drug exposure, azacitidine treatment was associated with fewer grade 3-4 cytopenias and shorter hospitalisation time than LDara-C in these higher-risk MDS patients.
Clinical Trials Related to Vidaza (Azacitidine Subcutaneous)
Azacitidine and CAPOX in Metastatic Colorectal Cancer [Active, not recruiting]
The goal of the Phase I portion of this study is to find the highest tolerable dose of
azacitidine combined with capecitabine and oxaliplatin (CAPOX) that can be given to patients
with metastatic colorectal cancer.
The goal of the Phase II portion of this study is to learn if azacitidine, given in
combination with CAPOX, can help to control metastatic colorectal cancer. The safety of
this drug combination will also be studied.
An Open-label Study of Lirilumab (BMS-986015) in Combination With 5-azacytidine (Vidaza) for the Treatment of Patients With Refractory/ Relapsed Acute Myeloid Leukemia [Recruiting]
The goal of this clinical research study is to find the highest tolerated dose of the
combination of lirilumab and 5-azacytidine that can be given to patients with AML or
high-risk MDS. Researchers also want to learn if the drug combination can help to control
the disease. The safety of the drug combination will also be studied.
A Study of Nivolumab (BMS-936558) in Combination With 5-azacytidine (Vidaza) for the Treatment of Patients With Refractory/ Relapsed Acute Myeloid Leukemia [Recruiting]
There are 2 parts to this study: Part A (dose escalation) and Part B (dose expansion).
The goal of Part A of this clinical research study is to find the highest tolerable dose of
nivolumab and 5-azacytidine that can be given to patients with AML. The goal of Part B of
this study is to learn if the dose found in Part A can help to control AML.
The safety of this drug combination will also be studied.
Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS) [Recruiting]
The goal of this clinical research study is to compare how 2 different drugs, decitabine and
azacitidine, when given on a shorter than standard dosing schedule, may help to control MDS.
The safety of each study drug given on these schedules will also be studied.
Azacitidine (AZA) in Minimal Residual Disease (MRD) Chronic Myeloid Leukemia (CML) [Active, not recruiting]
This is a 2 part study. The goal of the first part of this clinical research study is to
find the highest tolerable dose of azacitidine that can be given with a TKI that you are
already taking (such as Gleevec, Sprycel, or Tasigna). The safety of this drug will also be
studied. The goal of the second part is to see if this combination may improve your response
to the TKI you are already taking.
Azacitidine is designed to change genes that are thought to cause leukemia. By changing
these genes, the drug may help to stop them from causing the disease to grow.
Reports of Suspected Vidaza (Azacitidine Subcutaneous) Side Effects
Pneumonia (173),
Febrile Neutropenia (165),
Sepsis (163),
Death (148),
Acute Myeloid Leukaemia (135),
Thrombocytopenia (102),
Pyrexia (99),
Platelet Count Decreased (91),
Neutropenia (84),
White Blood Cell Count Decreased (75), more >>
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