Trial Overview

Phase II Randomised Trial of 5-Azacitidine versus 5-Azacitidine in combination with Vorinostat in patients with Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndromes Ineligible for Intensive Chemotherapy.

Inclusion criteria

  1. Adults with AML (except Acute Promyelocytic Leukaemia (APL))
    1. Newly diagnosed or patients with high risk MDS categorised as INT-2 or high risk according to the International Prognostic Scoring System  who are deemed ineligible for intensive chemotherapy on the grounds of age or co-morbidities with ONE of the following disease status:
      1. Relapsed Disease: patients must have achieved a previous morphological CR and show evidence of recurrent disease.
      2. Refractory Disease: patients who have failed to achieve a morphological CR with previous therapy
  2. Patients are able to receive treatment as an out-patient
  3. Adequate renal and hepatic function
  4. Patients have given written informed consent
  5. Eastern Cooperative Oncology Group (ECOG) performance status less than 2.

Exclusion criteria

  1.  Patients with greater than class III of the New York Heart Association (NYHA) cardiac impairment.
  2. Blastic transformation of Chronic Myeloid Leukaemia (CML)
  3. Prior allogeneic/autologous haematopoietic stem cell transplant (HSCT)
  4. Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test within 7 days prior to the start of treatment)
  5. Adults of reproductive potential not willing to use appropriate, effective, contraception during the trial and for specified amount of time afterwards.
  6. Patients who have received prior histone deacetylase inhibitor (HDACi) treatment as anti-tumour therapy. (Patients who have received HDACi treatment for other indications e.g valproic acid for epilepsy may enrol after a 30-day washout period).
  7. Previous anti-tumour therapies, including prior experimental agents or approved anti-tumour small molecules and biologics, within 30 days before the start of protocol treatment. (Patients receiving anti-tumour therapies to control blood counts may enrol into the trial and receive trial treatment simultaneously).
  8. Patients who have received prior treatment with demethylating agents such as 5-azacitidine or decitabine.
  9. Patients with contraindications to receiving azacitidine or vorinostat such as hypersensitivity, patients unable to have a subcutaneous injection or swallow oral capsules.
  10. Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B, or C) hepatitis.
  11. Any co-morbidity that could limit compliance with the trial.

Other trials currently active for Acute Myeloid Leukaemia

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AC220 in patients with AML

A phase 2 open label, AC220 monotherapy efficacy study in patients with acute myeloid leukaemia (AML) with FLT3-ITD activating mutations.

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AML 17

The AML 17 trial has two distinct parts:

i.For patients with acute myeloid leukaemia (AML), (other than acute promyelocytic leukaemia) and High Risk Myelodysplasia, as defined by the WHO Classification (2001) (Appendix A, protocol).

ii.For adults with acute promyelocytic leukaemia (APL).