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

NCT03488862 | Completed DMC

• 1 other identifier: LCCC 1702
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The purpose of this trial is to investigate whether a microfluidics assay can detect trace amounts of residual leukemia and predict relapse in acute myeloid leukemia (AML) patients in remission who have undergone allogeneic stem cell transplantation (SCT) or Induction and Consolidation Chemotherapy (ICC) at the North Carolina Cancer Hospital (NCCH). Procedures (methods): A total of 40 eligible subjects will be treated per standard of care with either SCT or induction and consolidation chemotherapy (ICC) based on the appropriate AML treatment paradigm for their disease. Peripheral blood (10 ml) for microfluidic chip analysis and possible Immune Monitoring Core Facility analysis will be collected along with routine lab draws prior to SCT. Patients in remission after SCT or those with confirmed remission by bone marrow biopsy after induction chemotherapy will be followed for 1 year; and peripheral blood (20 ml) will be collected to assess MRD by standard methods or by microfluidic chip analysis on a monthly basis. In addition, bone marrow biopsies will be performed at the end of consolidation (typically 5 months from remission), and at 1-year post remission in non-transplant patients. In transplanted patients, bone marrow biopsies will be collected at + 30 days, + 90 days, +180 days, and +360 days after SCT.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Assessment of rising Minimal Residual Disease

  The number of detected AML cells will be recorded for each obtained blood sample. An indicator of relapse is when the number of AML cells exceeds the threshold pre-specified before the study. The goal is to evaluate the sensitivity and specificity of the device against clinically confirmed relapse.

  The study will enroll 40 subjects with newly diagnosed or suspected AML or those who are transplant eligible. Subjects with confirmed remission after induction chemotherapy or after SCT will be followed for 1 year.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Lineberger

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Residual blood samples may be stored by the sponsor as backup to be used to confirm downstream assays using staining, fluorescence-activated cell sorting (FACS).

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Paul Armistead, MD

  UNC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 5, 2018
• Study Start: March 1, 2018
• Primary Completion: October 28, 2020
• Study Completion: October 28, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)