Chronic Myeloid Leukemia (CML) with substained Complete Molecular Response (CMR). MedDRA version: 14.1 Level: LLT Classification code 10052065 Term: Chronic phase chronic myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: GLIVEC*30CPS 50MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: IMATINIB MESILATE
CAS Number: 220127-57-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
UNIVERSITA' DEGLI STUDI DI MILANO - BICOCCA
Eligibility
Sex/Gender
All
Inclusion 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 CMR (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: 0 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 1. To estimate relapse rate after imatinib discontinuation. 2. To characterize the performances of the dPCR technique. 3. To quantify the maintenance of the molecular remission, after imatinib discontinuation, in CML patients with negative Q-RT-PCR for longer than 18 months. 4. To evaluate the impact of imatinib treatment (discontinuation and resumption) on quality of life. 5. To assess the timing of recurrence. 6. To quantify the occurrence of progression/resistance in patients who relapse after imatinib resumption. 7. To evaluate whether survival of patients dPCR negative and relapse free at 36 months is comparable to the one of normal population. 8. To evaluate whether survival of relapsing patients is comparable to the survival of the non relapsing ones.;Primary end point(s): The Negative Predicted Value Ratio (rNPV) of dPCR over Q-RT-PCR, i.e. the capability of the dPCR method to predict relapse-free patients relative to the standard method. NPV of each method will be computed as the number of patients who are negative according to either method at the time of imatinib discontinuation and remain relapse-free 36 months later over the total of negative patients according to either method, respectively.;Timepoint(s) of evaluation of this end point: At 36 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Rate of molecular and cytogenetic relapse after discontinuation of imatinib treatment out of total number of patients enrolled. 2. Rate of patients who are dPCR positive before discontinuation of imatinib and who do not relapse within the following 36 months (false positive) out of the total number of relapse-free patients at month 36. 3. Rate of patients who are dPCR negative before discontinuation of imatinib and who relapse (false negative) out of the total number of patients relapsing within the following 36 months. 4. Rate of patients maintaining dPCR negativity for 36 months over the patients who are Q-RT-PCR negative at the end of the interval. 5. Time to molecular relapse, both from the first PCR negative and from the discontinuation of imatinib to the time of loss of molecular response, respectively. 6. Overall survival. 7. Quality of Life, as measured by the Global Health Status/QOL and other subscales scores of EORTC-QLQ-C30 questionnaire. 8. Rate of patients progressing or developing resistance after imatinib resumption out of total number of patients enrolled.;Timepoint(s) of evaluation of this end point: All at 36 months, except for the overall survival (point 6) that will be evaluated at the end of the study. | — |
Countries
Canada, Germany, Israel, Italy, Netherlands, Spain
Contacts
Public ContactDip. Medicina Clinica e Prevenzione
Universita' degli Studi Milano Bicocca
Outcome results
None listed