An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years

Phase 3 Terminated 14 enrolled Prof. Dr. Nikolas von Bubnoff Novartis · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multicenter, randomised phase 3b clinical trial of Imatinib 400 to 800 mg daily versus Nilotinib 300 mg two times daily in chronic phase CML patients with confirmed MMR without MR4.5

Timeline

Start: 2014-03
Primary completion: 2018-12
Completion: 2019-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Imatinib	Small molecule	400 mg	Oral
Subject	Imatinib	Small molecule	800 mg	Oral
Comparator	Nilotinib	Small molecule	300 mg	Oral

An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years

Summary

Timeline

Drugs

Indications