Pilot Evaluation of a Microfluidic Assay to Detect Minimal Residual Disease and Predict Relapse in AML Patients

Inclusion Criteria:

1. Adult patients (≥18 years of age) with newly diagnosed or suspected AML who are going to undergo stem cell transplant (SCT) or are being treated with induction and consolidation chemotherapy (ICC) at the NCCH are eligible. These subjects must provide written informed consent to participate.

   --For the purposes of this study, induction chemotherapy is any therapy intended to induce remission in AML patients that combines anthracycline/anthracenedione with cytarabine; or combinations of cytarabine at a dose of ≥1 g/m2/dose x ≥ 5 doses with a purine analogue. Liposomal combinations of anthracycline and cytarabine are also considered induction therapy. Subjects receiving investigational induction therapies will be eligible as long as the standard-of-care agents within the induction therapy fulfills criteria above.

   For the purposes of this study, specific choice of consolidation chemotherapy, or decision to pursue SCT in remission are not mandated prior to enrollment, as these decisions are not typically made until after induction chemotherapy has been given.
2. Subjects scheduled for SCT or ICC must have confirmed CD33-, CD34-, CD117- or CD123-positive disease to qualify for enrollment to undergo serial blood draws for assessment of MRD by microfluidic chip analysis.
3. Subjects may be enrolled after beginning induction chemotherapy, provided that sufficient AML blasts are available in the pre-treatment peripheral blood or bone marrow sample to confirm that the blasts express CD33, CD34, CD117 or CD123.

Exclusion Criteria:

1. Adult patients (≥18 years of age) with newly diagnosed or suspected AML who are scheduled to undergo SCT or ICC at the NCCH who do not provide written informed consent to participate are ineligible.
2. Patients who are receiving non-intense therapies for AML that do not contain anthracycline/anthracenedione or dual analog therapies. Such non-intense therapies include: DNA methyltransferase inhibitors (azacitidine/decitabine), combinations including DNA methyltransferase inhibitors, cytarabine monotherapy at doses below 1 g/m2 x 5, purine analog monotherapy or investigational therapies that are not combined with standard induction agents.
3. Subjects who test negative for the leukemic blasts surface antigens CD33, CD34, CD117, and CD123 are ineligible for inclusion to undergo serial blood draws for assessment of MRD by microfluidic chip analysis.