Nilotinib Plus Pegylated Interferon-α2b in CML

Phase 2 Terminated 20 enrolled Amsterdam UMC, location VUmc Merck Sharp & Dohme LLC · collab Novartis · collab Uppsala University Hospital · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this trial is to assess the effect of switching CML patients, who have been treated with imatinib ≥ 2 years and who have stable detectable molecular residual disease between 0.01-1.0% (IS), to the combination of Nilotinib and PegIFN, in terms of the proportion of patients who achieve confirmed MR4.0.

Timeline

Start: 2013-04
Primary completion: 2016-04-08
Completion: 2016-05-01

Outcome

Met primary endpoint

Stopped (Enrollment): “insufficient enrollment”

paper The primary endpoint of confirmed MR4.0 at month 12 (a BCR-ABL1IS level ≤ 0.01% both at 12 and 15 months) was reached by 44% (7/16 patients PMID 37119314 ↗

Publications

Geelen IGP, Gullaksen SE, Ilander MM, Olssen-Stromberg U, Mustjoki S, Richter J, Blijlevens NMA, Smit WM, Gjertsen BT, Gedde-Dahl T, Markevarn B, Koppes MMA, Westerweel PE, Hjorth-Hansen H, Janssen JJWM. Switching from imatinib to nilotinib plus pegylated interferon-alpha2b in chronic phase CML failing to achieve deep molecular response: clinical and immunological effects. Ann Hematol. 2023 Jun;102(6):1395-1408. doi: 10.1007/s00277-023-05199-1. Epub 2023 Apr 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nilotinib	Small molecule	300 mg	Oral
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	40 ug	Subcutaneous