Trial Profile
A prospective, randomized, open label two arm Phase III study to evaluate treatment free remission (TFR) rate in patients with Philadelphia chromosome-positive CML after two different durations of consolidation treatment with nilotinib 300mg BID
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 13 Apr 2022
Price :
$35
*
At a glance
- Drugs Nilotinib (Primary)
- Indications Chronic myeloid leukaemia
- Focus Registrational; Therapeutic Use
- Acronyms ENESTPath
- Sponsors Novartis; Novartis Pharmaceuticals
- 14 Dec 2021 Primary endpoint (Percentage of Participants Who Remained in Treatment Free Remission (TFR) Without Molecular Relapse 12 Months After Entering the TFR Phase) has not been met, as per results presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
- 14 Dec 2021 Results assessing the impact of 12 or 24 months of Nilotinib 300 mg BID CONS, on the treatment-free remission rate in patients who had not achieved sustained deep molecular response with imatinib, presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
- 27 Jul 2020 Status changed from active, no longer recruiting to completed.