Clinical trial · Observational
Treatment With Second Generation Tyrosine Kinase Inhibitors (2G TKI) Post Imatinib Failure Survey
Treatment With Second Generation TYROSINE KINASE INHIBITORS (2G TKI) Post Imatinib Failure: Factors Predicting Response and Predictive Value of Response
NCT01188278CI-TRIAL-00024109completedClinicalTrials.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 determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR).
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 |
|---|---|---|---|
| Leukemia, Myeloid, Chronic-Phase (CML-CP) | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients in CP-CML treated with 2G TKI
- description
- Patients in CP-CML treated with 2G TKI (nilotinib or dasatinib) post imatinib failure
- interventionNames
- Drug: Imatinib
Primary outcomes (1)
- measure
- Predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR)
- timeFrame
- CCyR at 6 month of 2GTKI treatment
- description
- The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR), as assessed by the following: * Distribution of patients according to Hammersmith score levels * Characterization of association between Hammersmith score and occurrence of CCyR * Assessment of capacity of Hammersmith score to predict CCyR, using diagnostic test assessment methods. This score is measured at the time of imatinib failure.
Secondary outcomes (5)
- measure
- Predictive value of Hammersmith score on Major Molecular Response (MMR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Patients with Additional Chromosomal Anomalies (ACA) are accepted to be in CP. Patients enrolled in open-label clinical trials or other observational trials are also allowed (unless explicitly prohibited by the trial). This trial does not prohibit participation in other observational trials. Inclusion Criteria: * Patients diagnosed with CP-CML. (ACA) are allowed * Age \>18 years old * Prior treatment with imatinib monotherapy as first line treatment, to which the patient is deemed resistant or intolerant.Patients treated by INF and/or AraC prior (but not concomitant) to imatinib are eligible. * Initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-Jun-2009. Exclusion Criteria: * Patients in (or with history of) accelerated or blastic phase CML * Patients treated by allogeneic stem cell transplantation. * Any other CML treatment except for INF and/or AraC,and a short period of Hydroxyurea or Anagrelide prior to imatinib. * Patients treated with 2G TKI for reasons other than imatinib failure. * Patients with no historical data (e.g. possibility of Sokal Score calculation) available. * Patients participating in clinical or observational trials which explicitly prohibit enrollment in non interventional studies.
References
Publications (0)
Data not yet available
No reference posted for this study.