EUCTR2011-002749-37-ES
Active, not recruiting
Phase 1
Validation of digital-PCR analysis through programmed imatinib interruption in PCR negative chronic myeloid leukemia patients.
niveristy of Milano-Bicocca0 sites100 target enrollmentDecember 21, 2011
DrugsGlivec
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niveristy of Milano-Bicocca
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 75
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 25
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.
Outcomes
Primary Outcomes
Not specified
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