NCT02272478 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations (AML18) (NCT02272478)

Trial Description
AML 18 is the replacement trial for AML16 intensive. This 1600 patient trial is primarily designed for patients over the age of 60 who are considered fit enough for an intensive chemotherapy approach and will aim to test the effects of adding 1 of 2 new treatment agents to commonly used chemotherapy combinations in order to improve patient survival and treatment regimes.

The AML18 Trial is available to any patient who has primary or secondary AML as defined by the WHO Classification (excluding Acute Promyelocytic Leukemia), or high risk Myelodysplastic Syndrome (i.e. >10% marrow blasts) over the age of 60.

AML18 is a randomised controlled Phase III trial using a factorial design for maximum efficiency to evaluate two induction options followed by treatment with a small molecule post course 1 and dose intensification for suitable patients.

There are four randomisation comparisons within the trial:

The first randomisation will compare standard the chemotherapy schedule daunorubicin (DaunoXome®; Gilead Sciences Inc.)/ cytarabine (DepoCyt®; Sigma Tau Pharmaceuticals) (DA) combined with 1 or 2 doses of gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories) in course 1. Patients not suitable to receive gemtuzumab ozogamicin may have DA alone. Following recovery from course 1 patients who fail to achieve completer response (CR) or are Minimal Residual Disease (MRD-) positive by centralised flow cytometry will be randomised to one of three options, either DA chemotherapy, DA chemotherapy plus cladribine (Leustatin®; Janssen Pharmaceuticals) or Flag Ida for up to 2 courses of therapy.

Patients who achieve complete response (CR) after course 1 will be randomized to 1 or 2 further courses of DA chemotherapy.

At course 2 all patients will also enter a randomization to receive AC220 (quizartinib)* vs. no AC220 with or without maintenance, or ganetespib** vs. no ganetespib for a maximum of 3 cycles. Patients will be eligible for a non-intensive allogeneic stem cell transplant if a suitable HLA matched donor is available.

This trial is sponsored by Cardiff University. [1]

Study Data

  • Condition:
    • Acute Myeloid Leukemia (AML)
    • Myelodysplastic Syndrome
  • Interventions:
  • Phase: III
  • Estimated Enrollment: 1600
  • Start: October 2014
  • Completion: October 2020
  • Last verified: October 2014

Study Schematic

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* Quizartinib is a once-daily, orally administered, potent and selective inhibitor of FLT3, a validated target in the treatment of acute myeloid leukemia, or AML. The drug  is currently in development for the treatment of relapsed or refractory FLT3-ITD positive and negative AML patients and as a maintenance therapy.

** The investigational drug ganetespib is a small molecule inhibitor of heat shock protein 90 (Hsp90), a molecular chaperone required for the proper maturation and activation of numerous client proteins. The drug is being developed by Synta Pharmaceuticals.

Last Editorial review: July 23, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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