VIDAZA® Treatment for AMLb

Clinical Trials

VIDAZA® can prolong OS in AMLb patients1

Clinical study of VIDAZA® in WHO-defined AMLb (20-30% blasts)

Phase III, international, multicentre, controlled, parallel-group, open-label trial1,2

Subgroup analysis of AZA-0011,2

  • Approximately one third of patients enrolled in AZA-001 were FAB RAEB-T (? 20% to < 30%), meeting the WHO criteria for AML,1
  • Patients with WHO AML have a poor prognosis (median survival < 1 year) and poor response rates to chemotherapy1
  • This subgroup analysis evaluated the effects of VIDAZA® vs. conventional care regimens (CCR) on OS and response rates1

20.1 month median follow-up1

Learn more about the AZA-001 trial

AZA-001 Clinical Trial1

AZA-001 Clinical Trial

Baseline patient demographics and disease characteristics1

Baseline patient demographics and disease characteristics

VIDAZA® offers significant benefits in the following important patient outcomes

VIDAZA® treatment reduced the number of infections requiring IV antibiotics, per patient year, by nearly half compared to conventional care regimens.1

Number of infections requiring IV antibiotics, per patient year

A 21% reduction in hospitalization rates with VIDAZA® compared with CCR1

Rates of hospitalization per patient year

†Seven patients withdrew from the study before receiving treatment and were not included in the safety population; two of the patients were from the VIDAZA® group, and five were from the conventional care regimen group (best supportive care, n=2; low-dose cytarabine [ara-C], n=2; and intensive chemotherapy, n=1).1

††One patient (BSC only) had a bone marrow blast count of 13% but was included in the study based on a peripheral blast count of 20%. Subgroup analysis of a phase III, international, multicentre, randomised, controlled, parallel-group trial.2 The present analysis included patients with ≥20% BM or peripheral blasts based on central BM review (i.e., with FAB-defined RAEB-t and WHO-defined AML).1 s.c. = subcutaneous. ECOG = Eastern Cooperative Oncology Group.

§Conventional care regimens (Best supportive care [BSC] only, included in each arm, n=105; Low dose Ara-C [LDAC, 20mg/m2/d x 14d q28d], n=49; Intensive chemo [Ara-C, 100-200mg/m2/d by continuous IV infusion x 7d+3d IV daunorubicin 45-60mg/m2/d, idarubicin 9-12mg/m2/d, or mitoxantrone 8-12mg/m2/d], n=25)

  1. Fenaux P et al. J Clin Oncol 2010. 28:562-569.
  2. Fenaux P et al. Lancet Oncol 2009. 10:223-232.
a. MDS-specific Indication

VIDAZA® is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with:

  • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
  • chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder
b. AML-specific Indication:

Treatment of adult AML patients who are not eligible for haematopoietic stem cell transplantation with 20-30% blasts and multi-lineage dysplasia, according to the WHO classification. WHO classifies RAEB-T patients with blasts ?20% to <30% as AML patients.


This is an international website for VIDAZA® and is intended for healthcare professionals outside the US. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.

The information on this website is based on the European Summary of Product Characteristics (SmPC). Please refer to your country-specific website, or contact a Celgene representative in your country for the latest information specific to your country.