Specimen Collection from ALL or CML Patients with a Detectable BCR-ABL p190 Fusion Transcript Level

Clinical Trial Title

Specimen Collection For Analytical, Preclinical and Clinical Studies for the Xpert BCR-ABL Ultra p190 Test

Clinical Trial Protocol Description:

The purpose of this non-interventional, multi-site specimen collection protocol is the acquisition of peripheral blood (PB) specimens from ALL or CML patients with BCR-ABL p190 fusion gene transcript.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Have provided documented informed consent (or study participant’s parent or guardian has provided consent) and assent as required by the reviewing institutional review board (IRB) or human research ethics committee (HREC). Experimental Bill of Rights will also be documented for all study participants enrolled in applicable states.
  • Are 2 years of age or older.
  • Have been diagnosed with p190 ALL or CML less than or equal to six (6) months (180 days) prior to enrollment.
  • Have been diagnosed with p190 ALL or CML greater than or equal to six (6) months (180 days) and meets one or more of the following criteria:
    • Have been treated for p190 ALL or CML less than or equal to six (6) months (180 days) prior to enrollment.
    • Have a history of p190 ALL or CML treatment failure less than or equal to six (6) months (180 days) prior to enrollment.
    • Have a history of accelerated and/or blast phase disease less than or equal to six (6) months (180 days) prior to enrollment.
  • Agree to provide five (5) 4 mL EDTA tubes of PB.

You will be excluded from the study if any of the following criteria apply to you:

  • Clinician feels the study participant is not a suitable candidate for study specimen collection.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Deborah Katz, MD

Contact Information

Anne Timmermann