Clinical trial · Observational
Observational Study of Conception/Pregnancy in Adult Patients With CML Treated With Tyrosine Kinase Inhibitors
Observational Study of Conception/Pregnancy in Adult Patients With Chronic Myeloid Leukemia (CML) Treated With Tyrosine Kinase Inhibitors
NCT01752062CI-TRIAL-00055795CML1012unknownClinicalTrials.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 objective of this study is to acquire more information about what we are doing during pregnancy in CML patients, in order to possibly establish in the future a consensus on the management of patients receiving TKIs who wants to father a child or become/are pregnant.
Conditions
Conditions (2)
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 |
| Pregnancy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Number of normal birth, elective termination and spontaneous abortion
- timeFrame
- At 3 years from study entry
- description
- Pregnancy outcome: it will be calculated in terms of normal birth, elective termination, spontaneous abortion
- measure
- Number of patients with major molecular remission loss
- timeFrame
- At 3 years from study entry
- description
- Cumulative Incidence of MMR loss: it will be calculated from the date of achievement of MMR using the cumulative incidence method, where death will be considered as competing risk. Patients still alive, in first MMR, will be censored at the moment of last follow-up.
- measure
- Number of patients with disease progression
- timeFrame
- At 3 years from study entry.
- description
- Cumulative Incidence of Disease Progression: it will be calculated from the date of diagnosis using the cumulative incidence method, where death without signs of disease progression will be considered as competing risk. Patients still alive, without a date of progression, will be censored at the moment of last follow-up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years; * Ph+/BCR-ABL+ CML in any phase of disease; * Conception/pregnancy while diagnosed with CML * Treatment with TKIs (before or after pregnancy); * Signed written informed consent according to ICH/EU/GCP and national local laws. Exclusion Criteria: * Patient \< 18 years * Patients that suffer from any condition or illness that could prevent the patient to participate
References
Publications (0)
Data not yet available
No reference posted for this study.