Study for Continued Access to Imatinib for Patients Benefiting from Treatment in a Novartis-sponsored Study

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT01742299

Provider View

This study allows patients who are currently benefiting from imatinib treatment in a Novartis-sponsored study to continue using the medication. The decision is based on the investigator's assessment of the patient's benefit from the treatment.

Patient Parameters

Program Overview

The purpose of this study is to let patients who are already taking imatinib in a Novartis-sponsored study continue their treatment if they are benefiting from it. The investigator will decide if the patient is gaining positive effects from the medication.

Eligibility Criteria

Inclusion Criteria

  • Currently enrolled in a Novartis-sponsored study receiving imatinib and have completed all requirements of that study.
  • Benefiting from imatinib treatment as determined by the investigator.
  • Have followed the study rules and requirements as assessed by the investigator.
  • Willing and able to attend scheduled visits and follow the treatment plan and other study procedures.
  • Have provided written informed consent before joining this continuation study. If unable to provide written consent, it must be formally documented and witnessed by an independent trusted witness.

Exclusion Criteria

  • Have been permanently stopped from taking imatinib in the original study due to unacceptable side effects, not following study procedures, withdrawing consent, or any other reason.
  • Participated in a Novartis study where imatinib was given with another medication and are still receiving the combination therapy.
  • Pregnant or breastfeeding women.
  • Women who can become pregnant unless they use highly effective birth control during the study and for 30 days after the last dose of imatinib. Men must also use effective contraception during the study and for 30 days after the last dose.

Highly effective contraception includes:

  • Total abstinence (if it aligns with the person's lifestyle).
  • Female sterilization (surgical removal of ovaries or tubal ligation) at least six weeks before starting the study.
  • Male sterilization (at least 6 months before joining the study).
  • Use of hormonal birth control methods or an intrauterine device (IUD) with a failure rate of less than 1%.

Women are considered not able to become pregnant if they have had 12 months of natural menopause or have had surgery to remove reproductive organs.

If a patient becomes pregnant or thinks they might be pregnant during the study or within 30 days after the last dose of imatinib, they must inform the study doctor immediately and stop taking imatinib.

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