Validation of a new analytical method in asymptomatic chronic myeloid leukemia patients for whom the treatment with imatinib is suspended.

Phase 1

• Conditions: MedDRA version: 14.1 Level: LLT Classification code 10052065 Term: Chronic phase chronic myeloid leukaemia System Organ Class: 100000004864; Chronic Myeloid Leukemia (CML) with substained Complete Molecular Response (CMR).; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002749-37-DE
• Lead Sponsor: niveristy of Milano-Bicocca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-02
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

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.

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.
5.Admittance to an institution due to court order or by order by the authorities

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified