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A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy

Phase 2
18 Years
85 Years
Not Enrolling
Leukemia, Myelocytic, Acute, Myelodysplastic Syndromes

Thank you

Trial Information

A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy

A academic multicentre study whose aims are to study the benefits of a maintenance therapy
with 24 monthly courses af azacytidine in high-risk MDS patients, previously treated with
intensive chemotherapy with obtention of a partial or complete response and not eligible for
allogeneic transplantation

Inclusion Criteria:

- MDS with int 2 or high IPSS score eitherRAEB 1 or 2 according to the WHO
classification (see appendix 1) or CMML with WBC < 13 109/l RAEB-T according to the
FAB classification (see appendix 1) without t(8 ;21), inv 16 or t(16;16) AML
secondary to MDS (sAML) with a confirmed MDS phase of at least 2 months with
available bone marrow cytogenetics at diagnosis of AML


in CR or PR according to IWG criteria (see appendix 3) after one or two courses of
predefined intensive chemotherapy (see page 12) with available cytogenetics at evaluation
of response Aged 18 years of age or more Written Informed consent Adequate Contraception,
if relevant Negative pregnancy test if relevant. Patients not eligible for the
azacitidine confirmatory trial (azacitidine " versus " conventional treatment ") or
unwilling to participate to it

Exclusion Criteria:

- AML secondary to myeloproliferative or MDS/MPD WHO subgroups except CMML with WBC< 13

- Therapy related MDS (after chemo or radiotherapy for a previous neoplasm or immune

- Patients eligible for allogeneic bone marrow transplantation (with a identified

- Liver and/or kidney failures prohibiting the use of azacitidine. Creatininemia > 1.5
normal value ALAT and ASAT > 3N

- Bilirubin > 2 N, unless due to dyserythropoiesis

- Known hypersensitivity to azacitidine or mannitol

- Other tumor, unstable for the last three years, except in situ uterine carcinoma or
basal skin tumor

- Uncontrolled infection,

- WHO Performance status > 2

- Life expectancy less than 3 months

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reponse duration and cumulative incidence of relapses

Outcome Time Frame:

1-24 months

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Francophone des Myelodysplasies


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GFM aza05



Start Date:

July 2006

Completion Date:

July 2010

Related Keywords:

  • Leukemia, Myelocytic, Acute
  • Myelodysplastic Syndromes
  • MDS
  • Myelodysplastic Syndromes
  • AML
  • Intensive chemotherapy
  • azacitidine
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia