Clinical trial · Interventional
Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients
Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients (ISAV)
NCT01578213CI-TRIAL-00042045ISAVcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib
- interventionNames
- Drug: Imatinib mesylate
Primary outcomes (1)
- measure
- The Negative Predicted Value Ratio (rNPV) of dPCR over Q-RT-PCR
- timeFrame
- At 36 months.
- description
- 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
Secondary outcomes (8)
- measure
- Rate of molecular and cytogenetic relapse
- timeFrame
- At 36 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.