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Vidaza / Azacitidine: Know more about this drug

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Are Vidaza and Azacitidine the same drug? Why does it have two names?

Vidaza and Azacitidine are the same drug

Azacitidine is the official generic and non-proprietary name given to the drug active ingredient while Vidaza is its trade name.

The drug is widely available in the UK for the treatment of MDS since its approval in February 2011 by NICE - the National Institute for Health and Clinical Excellence (NICE). MDS UK Patient Support Group was in consultation with NICE during the approval process and campaigned for the approval of drug.

Is Azacitidine (Vidaza) a chemotherapy?

Azacitidine is a chemotherapy drug, however, it is a "hypomethylating agent". Hypomethylating agents are considered a non-intensive treatment.

They are aimed at slowing the progression of the disease with as few side effects as possible, maintaining a good quality of life. They will not cure MDS but may ‘modify’ it.

How does Azacitidine work?

Azacitidine works at the DNA level, "switching on" genes that stop the cancer cells growing and dividing. This reduces the number of abnormal blood cells and helps to control cell growth.

It is recommended as a treatment option for adults who are not eligible for stem cell transplantation and have intermediate-2 and high-risk myelodysplastic syndromes according to the International Prognostic Scoring System (IPSS) (See more at Nice Website).

How is Azacitidine administered?

You have azacitidine as an injection just under your skin (subcutaneously) given by a doctor or nurse. This can be in your upper arm, leg, buttock or stomach. You usually have it as an outpatient but there have been successful experiences with home administration.

You will have azacitidine as a course of several cycles of treatment. You can a treatment each day for a week and then 3 weeks with no treatment. This makes up a treatment cycle. You normally have at least 6 cycles and the treatment continues for as long as it is working.

You can also have it every day, for 5 days. Then have 2 days off and have azacitidine again for 2 days at the start of the next week.

The Treatment Involves Several Courses

The Treatment with Vidaza/Azacitidine Involves Several Courses
Joseph Bella: MDS patient experience of Azacitidine and Bone Marrow Transplant

Joseph Vella: MDS patient experience of azacitidine and stem cell transplant

"I hope and trust that my little story could encourage other MDS sufferers to decide to go through with the treatment"

Azacitidine (Vidaza): Latest research

Azacitidine is an important drug for the treatment of MDS but not all patients will respond to the treatment. Some will progress to leukaemia, others won't have an adequate response in terms of their blood count.

At the 14TH INTERNATIONAL SYMPOSIUM ON MYELODYSPLASTIC SYNDROMES, that took place in Valencia in May 2017, one of the topics discussed was the latest research around this important drug. Read more about how researchers are trying to establish which patients will have a good outcome with Azacitidine and whether the use of Azacitidine together with other drugs can make the treatment more effective.

Learn more about the latest MDS research: Download the full MDS Symposium Patient Summary

Predicting Good Outcomes with Vidaza/Azacitidine Treatment

Researchers are exploring which factors might be useful for predicting a good outcome in patients with MDS.

Certain treatment decisions for patients with MDS are based on cytogenetics, i.e. the study of the chromosomes. Azacitidine is appropriate for patients with higher risk MDS who often have mutations in chromosome 7 or three or more abnormalities in their chromosomes.

Dr. Raphael Itzykson, Université Paris Diderot, France, presented a study showing that if the platelet count after one cycle of the drug doubles, this is a good sign for an overall success of the treatment. However this happens in only a small proportion of patients.

Several ongoing efforts, including the HARMONY study, have a good chance of identifying more factors that predict azacitidine outcomes in MDS and other blood cancers and of predicting the effects of treatment on the patient's quality of life, healthcare costs, and care strategies.

The Best Partner for Vidaza/Azacitidine in Higher-Risk MDS

Dr. Mikkael Sekeres (Cleveland Clinic, Ohio) focused his presentation on combinations of Azacitidine and other drugs for higher-risk MDS.

The combination of Azacitidine and vorinostat seemed promising. In a phase II clinical trial, about 70% of patients with untreated higher-risk MDS, CMML, or AML responded to the treatment, which was about double the expected rate for azacitidine alone. These responses lasted an average of 16 months.

Similarly, response rates and duration of response were promising in a phase I-II clinical trial of the combination of lenalidomide and azacitidine for higher-risk MDS.

Dr. Fenaux added that studies are also evaluating combinations of Azacitidine with other treatments, such as valproic acid, venetoclax, immune checkpoint inhibitors, and idarubicin for higher-risk MDS or CMML.

Establishing The Correct Dose

Other research is assessing more intensive hypomethylating treatments or lower doses for longer use. Studies are testing different drugs, including venetoclax, cenersen, and a 10-day decitabine cycle (another hypomethylating agent) for MDS with TP53 mutations.

Dr. Sekeres concluded that azacitidine alone is still the standard treatment for higher-risk MDS. But some evidence
hints at better and more long-lasting responses for combination treatments if patients stay on them long enough. The hypomethylating drug “partners” under investigation might become options for higher-risk MDS in some patients.

Clinical Trials open to recruitment in the UK


PANTHER: Clinical Trial Open to Recruitment

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

PANTHER

  1. SUB-TYPE OF MDS:Higher risk MDS, CMML, low blast count AML
  2. SEVERITY OF MDS: Intermediate, high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R)
  3. NAME OF DRUG: Azacitidine, Pevonedistat
  4. Aims and benefits: Pevonedistat prevents the activity of a specific enzyme (Nedd8 activating enzyme) and thus may result in the inhibition of tumour cell growth and survival. This is a phase 3 study to determine if combining Pevonedistat with Azacitidine improves survival when compared with single agent Azacitidine.

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BRIGHT: Clinical Trial Open to Recruitment

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

BRIGHT

  1. SUB-TYPE OF MDS:Previously untreated higher-risk MDS, AML or CMML
  2. SEVERITY OF MDS: Intermediate, high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R)
  3. NAME OF DRUG: Glasdegib, Azacitidine
  4. Aims and benefits: PGlasdegib disrupts cancer stem cell survival. This has the potential to reduce the development of drug resistance and prevent relapse. This is a Phase 1b study aimed at determining the safety and effectiveness of Glasdegib in combination with Azacitidine in this specific patient group.

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CPDR001X2105: Clinical Trial Open to Recruitment

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed in our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

CPDR001X2105

  1. SUB-TYPE OF MDS:High risk MDS and AML, not suitable for induction chemotherapy or haemopoietic stem cell transplant
  2. SEVERITY OF MDS: High Risk MDS
  3. NAME OF DRUG: PDR001, MBG453, Decitabine
  4. Aims and benefits: PDR001 is a monoclonal antibody that functions to block the activity of PD-1 (programmed cell death protein 1) thus allowing T-cells to recognise and target cancer cells. MBG453 is a monoclonal antibody that binds to a specific protein found on the surface of T-cells thus allowing the T-cell to function normally against cancer cells by reducing tumour growth. This is a phase 1b study aimed at determining the safety and tolerability of the study drugs alone and in combination with decitabine. The study also aims to determine the recommended doses of each of these drugs.

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RFUSIN2AML2: Clinical Trial Open to Recruitment

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed on our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

RFUSIN2AML2

  1. SUB-TYPE OF MDS: High Risk MDS RAEB-2 and Acute Myeloid Leukaemia Patients Unsuitable for Allogeneic Haematological Stem Cell Transplant
  2. SEVERITY OF MDS: High Risk MDS
  3. NAME OF DRUG: B7.1 (CD80)/IL-2 Immune Gene Therapy
  4. Aims and benefits: This is a phase I study intended to identify the safety and tolerability of an "AML Cell Vaccine" given to eligible MDS and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.

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FT-2102: Clinical Trial Open to Recruitment

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed on our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

FT-2102

  1. SUB-TYPE OF MDS: Patients with Acute Myeloid Leukaemia or Myelodysplastic Syndrome with an IDH1 R132 mutation
  2. SEVERITY OF MDS: Intermediate, high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R)
  3. NAME OF DRUG: FT-2102
  4. Aims and benefits: FT-2102 is an inhibitor of the mutation IDH1, which is seen in 7-14% of
    This is a phase 1/2 study of FT-2102 as a single agent and in combination with azacitidine or low dose cytarabine. The study aims to determine the safety and effectiveness of FT-2102 in this specific patient group.

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MEDI4736

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed on our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

MEDI4736

  1. SUB-TYPE OF MDS: Patients who have previously received a hypomethylating agent (eg. Azacitidine, Decitabine)
  2. SEVERITY OF MDS: Intermediate-2 or High risk
  3. NAME OF DRUG: Durvalumab, Tremelimumab, Azacitidine
  4. Aims and benefits: This is a Phase 1 study for patients who have previously received a hypomethylating agent. Durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1) which activates the immune system to exert a response against tumour cells expressing PD-L1. Tremelimumab is a monoclonal antibody that stimulates the immune system to attack tumour cells. It does this by switching off the inhibitory mechanisms that stop tumour cells from being destroyed. This study aims to determine the safety and tolerability of MEDI4736 as Monotherapy or in Combination With Tremelimumab With or Without Azacitidine.

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Lenalidomide in MDS Patients with Del 5q – Clinical Trial Open to Recruitment

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed on our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

Lenalidomide in MDS Patients with Del 5q

  1. SUB-TYPE OF MDS: Del 5q
  2. SEVERITY OF MDS: Low or Intermediate
  3. NAME OF DRUG: Lenalidomide
  4. Aims and benefits: This trial will investigate how lenalidomide, Revlimid®, affects the disease progression of patients with transfusion dependent MDS. This is a registry, non-interventional study.

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Deferasirox + EPO study

*CLOSED TO RECRUITMENT*

  1. SUB-TYPE OF MDS: All.
  2. SEVERITY OF MDS: Low to Intermediate 1
  3. NAME OF DRUG: Deferasirox and Erythropoietin (EPO)
  4. Aims and benefits: This trial will assess the impact on hemoglobin, platelets and neutrophil, and iron levels in patients treated with Deferasirox combined with Erythropoietin (compared to Erythropoietin alone)

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Rigosertib Intravenous – INSPIRE – Clinical Trial Open to Recruitment

Research FOR Patients
-For an informed and empowered opinion-

All the trials listed on our site have been properly vetted for scientific accuracy. Many thanks to Dr Simone Green – Hull and East Yorkshire Hospitals NHS Trust - for the continuous work in updating the listing.

Rigosertib Intravenous

  1. SUB-TYPE OF MDS: All.
  2. SEVERITY OF MDS: All.
  3. NAME OF DRUG: Rigosertib
  4. Aims and benefits: This trial will investigate the survival of MDS patients receiving intravenous Rigosertib after failure of treatment with a Hypomethylating agent (HMA), Azacitidine (aza) or Decitabine (DEC)

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