A Global Imatinib and Nilotinib Pregnancy Exposure Registry

Novartis

Status: Completed

Conditions: All Indications for Glivec/Gleevec and Tasigna

Treatments: Drug: Tasigna; Drug: Gleevec

Study type: Observational

Funder types: Industry

Identifiers

NCT01289054

CSTI571A2403

Details and patient eligibility

About

This is a voluntary, international, primarily prospective, observational, exposure-registry and follow-up study of women receiving Imatinib and Nilotinib during pregnancy or within six months prior to pregnancy.

Enrollment: 4 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide sufficient evidence to confirm that exposure occurred during pregnancy or within 6 months prior to exposure.
• Be at least 18 years of age
• Reside in a country supported by the Registry

Exclusion criteria

• Cases that do not meet the eligibility criteria are deemed ineligible, including paternal exposures

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

4 participants in 2 patient groups

Cohort 1 - Pregnancy/Fetal Exposure

Treatment:

Drug: Gleevec

Drug: Tasigna

Cohort 2 - Interrupted TKI