Specimen Collection from ALL or CML Patients for the Xpert BCR-ABL Ultra p190 Test

Clinical Trial Title

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

Clinical Trial Protocol Description:

The purpose of this study is to collect blood specimens which will be used to help develop and evaluate a new test for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). This test is a test that could help doctors detect and measure the BCR-ABL p190 marker, which is found in the blood of some patients with CML or ALL.

Clinical Trial Eligibility Criteria:

Prospective Collection

In order to participate you must meet the following criteria:

  • Have documentation that the study participant (or study participant’s parent or guardian) has provided informed consent or 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 two (2) years of age or older.
  • Have a history of BCR-ABL p190 fusion gene transcript positive for ALL or CML.
  • Agree to provide two (2) 6 mL EDTA tubes of PB.

NOTE: A study participant may be enrolled more than once at different SOC visits. As much as possible, Cepheid will collect information to link specimens collected from the same patient at different timepoints while ensuring that the specimen remains de-identified.

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.

Leftover SOC Specimen

In order to participate you must meet the following criteria:

  • Specimen is from a patient with a history of BCR-ABL p190 fusion gene transcript positive ALL or CML.
  • Specimen is a PB specimen collected in an EDTA tube.
  • Specimen was stored at 2-28ºC up to 24 hours or 2-8ºC up to 72 hours following enrollment.
  • Specimen volume is > 4 mL ORA: 19031304-IRB01 Date IRB Approved: 12/30/2019 Amendment Date: 

NOTE: A leftover SOC specimen may only be enrolled one time from the same visit. However, leftover SOC specimens collected at different timepoints from the same patient may be enrolled. As much as possible, Cepheid will collect information to link specimens collected from the same patient at different timepoints while ensuring that the specimen remains de-identified.

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

  • Specimen was collected > 72 hours prior to enrollment.

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