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Conception and pregnancy in adults with chronic myeloid leukaemia (CML) in the era of tyrosine kinase inhibitors: retrospective survey on the course and outcome of pregnancies and on therapy and disease control in CML

Conception and pregnancy in adults with chronic myeloid leukaemia (CML) in the era of tyrosine kinase inhibitors: retrospective survey on the course and outcome of pregnancies and on therapy and disease control in CML - CML-PregReg

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028837
Enrollment
50
Registered
2023-01-31
Start date
2023-08-12
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C92.1 Z35

Interventions

Group 1: CML patients who have been pregnant since the introduction of TKIs or CML patients who have fathered a child while on TKI therapy will be invited to complete a one-time retrospective set of q

Sponsors

Universität Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Written informed consent to study participation. - age = 18 years - Diagnosis of CML (detection of Philadelphia chromosome or CML fusion gene) or conception with a man with confirmed CML diagnosis treated with TKI or < 1 month after the end of TKI therapy - Pregnancies in female CML-patients that existed at the time of CML diagnosis or occurred thereafter since 11/2001, or fathering by male CML patients after diagnosis of CML since 11/2001 - TreatmentL with tyrosine kinase inhibitors (TKI) before, during, or after pregnancy, or before or during fathering.

Exclusion criteria

Exclusion criteria: No exclusion criteria

Design outcomes

Primary

MeasureTime frame
Retrospective collection of data from patients with CML and from their pregnant partners on a) on the effect of pregnancy or the desire to have children on the choice of therapy and the further course of CML b) on the outcome of pregnancies and births (including complications, prenatal and congenital abnormalities) in the TKI era.

Secondary

MeasureTime frame
I. Recording of the scope and quality of counselling of CML patients with regard to family planning as well as the chances and risks of a CML therapy geared to this. II. recording of the measures taken in care to preserve fertility and reproductive ability (e.g. cryopreservation).

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026