Validation of digital-PCR analysis through programmed imatinib interruption in PCR negative chronic myeloid leukemia patients.

Phase 4

Completed

Conditions: Chronic Myeloid Leukemia (CML) with sustained Complete Molecular Response (CMR) / Chronic Myeloid Leukemia (CML) asymptomatic and with no sign of disease by the most sensitive conventional hospital investigations.
10024324

Registration Number: NL-OMON37795

Lead Sponsor: niversity of Milano-Bicocca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

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 least 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 in 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Negative Predicted Value Ratio (rNPV) of dPCR over Q-RT-PCR, i.e. the<br /><br>capability of the dPCR method to predict relapse-free patients relative to the<br /><br>standard method. NPV of each method will be computed as the number of patients<br /><br>who are negative according to either method at the time of imatinib<br /><br>discontinuation and remain relapse-free 36 months later over the total of<br /><br>negative patients according to either method, respectively.</p><br>

Secondary Outcome Measures