NCT01289054

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

4.2 years

First QC Date

January 31, 2011

Last Update Submit

April 14, 2015

Conditions

All Indications for Glivec/Gleevec and Tasigna

Keywords

FemalePregnancyHematologic PregnancyComplicationsRegistryPregnant RegistryCMLGISTGleevecTasignaGlivecPregnancy Exposure

Outcome Measures

Primary Outcomes (1)

  • Monitor pregnancies exposed to Imatinib or Nilotinib to estimate prevalence of birth defects

    During pregnancy or within 6 months prior to conception

Secondary Outcomes (2)

  • Assess impact on maternal CML disease when treatment is interrupted

    During pregnancy or within 6 months prior to conception

  • Assess post 12 month post-delivery data on maternal and infant status

    12 months after birth

Study Arms (2)

Cohort 1 - Pregnancy/Fetal Exposure

Drug: TasignaDrug: Gleevec

Cohort 2 - Interrupted TKI

Interventions

TasignaDRUG
Cohort 1 - Pregnancy/Fetal Exposure
GleevecDRUG
Cohort 1 - Pregnancy/Fetal Exposure

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women exposed to any dose of Gleevec/Glivec or Tasigna during pregnancy or within 6 months prior to conception

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INC Research, LLC

Wilmington, North Carolina, 28405, United States

Location

MeSH Terms

Interventions

nilotinibImatinib Mesylate

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 3, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(1)