Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients

• Status: Completed
• Trial end date: 2018-11-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milano Bicocca
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

1. Signed and dated IRB/IEC-approved Informed Consent

2. Age>=18 years

3. Male or female patients with CML diagnosed in chronic or accelerated phase and who have been treated for more than 2 consecutive years with imatinib therapy

4. Sustained Complete Molecular Response (as defined by the treating center) for at least 18 months with imatinib treatment

5. A minimum of 3 CMR determined by Q-RT-PCR analysis to support disease status, with the list one performed within 3 calendar months prior to enrollment date

6. Willingness and ability to comply with scheduled visits laboratory tests and other study procedures

Exclusion Criteria:

1. Allogenic hematopoietic stem cell transplantation

2. Known active infections including human immunodeficiency virus (HIV) positivity

3. Current enrollment another clinical trial

4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results