Phase 3: Open-Label Randomized Study of Amonafide in Secondary AML

• Research type

  Research Study

• Full title

  Phase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination with Cytarabine Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid Leukemia (AML)

• IRAS ID

  19347

• Sponsor organisation

  Antisoma Research Limited

• Eudract number

  2007-004427-38

• ISRCTN Number

  xx

• Research summary

  This study will focus on a subgroup of acute myeloid leukemia (AML) which has very poor prognosis. Results from multi-center cooperative group trials indicate that patients with this subgroup of AML not only have a poor response from currently available therapies, but also have a short duration of response and survival. Recent reports from the Southwest Oncology Group reflect this with only 25% of these patients achieving complete remission (when leukemia cells cannot be seen in the bone marrow and blood, and blood cells have recovered to normal levels) following standard chemotherapy of Cytarabine and Daunorubicin.The goal of this clinical research study is to find out if amonafide, when given together with cytarabine is safe and effective in the treatment of AML. The combination of amonafide and cytarabine will also be compared with the standard treatment of daunorubicin and cytarabine. Approximately 150 hospital and cancer centres worldwide will consent and enroll roughly 420 patients that will be randomised to begin Course 1 of remission induction chemotherapy of either:Arm A: amonafide and cytarabine or Arm B: daunorubicin and cytarabinePatients with persistent leukemia on Day 14 bone marrow assessment will be re-treated with an additional course (Course 2) of the same remission induction chemotherapy regimen. Patients who achieve remission will receive post-remission therapy with either bone marrow or stem cell transplant or additional cytarabine.Follow-up clinic visits for subjects in remission will occur every 2 months for up to 2 years. Subjects that relapse, fail Course 1 or withdraw will receive a telephone follow-up call every 3 months for 2 years.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/70

• Date of REC Opinion

  17 Jul 2009

• REC opinion

  Further Information Favourable Opinion