DANTE = De-escalation and TFR Study in CML Patients Treated With Nilotinib Followed by a Second Attempt After Nilotinib and Asciminib Combination [Italy]

What is the purpose of the study

This study is will evaluate the rate of full treatment-free molecular remission at week 96 in CML-CP patients treated with nilotinib at half the standard dose (300 mg once daily) during a consolidation period of 12 months, followed by complete therapy cessation.

The study consists of 4 phases: screening, 48-week nilotinib consolidation phase, 96-week treatment-free remission (TFR) phase and follow up phase.

Patient who lose MMR at any time during the study will be restarted on nilotinib treatment at 300 mg twice daily.

What will happen during the study

Key inclusion criteria

This study includes male or female patients 18 years and older with CML in chronic phase who have been receiving first line treatment with nilotinib at 300 mg twice daily for at least 3 calendar years. At study entry, an ongoing treatment at a dose of ≥400 mg per day is allowed.

Patients can be considered for inclusion if they have had sustained molecular remission (MR4 or better with BCR-ABL results of no more than 0.01% on the international scale (IS) in the last 4 real time quantitative polymerase chain reaction (RQ-PCR) tests which were done at least 3 months but no more than 6 months apart.

To be eligible for inclusion, patients must also have acceptable laboratory values at screening and Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2.

Additional criteria may apply.

Key exclusion criteria

Patients with known atypical transcript.
Patients with CML treatment resistant mutation(s) that were detected in the past.
Patients who reduced or interrupted their doses due to neutropenia or thrombocytopenia in the past 6 months.
Patients who have attempted to permanently stop taking nilotinib.

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators

Italy

Novartis Investigative Site
Bari, 70124

Novartis Investigative Site
Bologna, 40138

Novartis Investigative Site
Cagliari, 09126

Novartis Investigative Site
Catania, 95123

Novartis Investigative Site
Catanzaro, 88100

Novartis Investigative Site
Firenze, 50134

Novartis Investigative Site
Genova, 16132

Novartis Investigative Site
Milano, 20122

Novartis Investigative Site
Milano, 20162

Novartis Investigative Site
Napoli, 80131

Novartis Investigative Site
Napoli, 80132

Novartis Investigative Site
Novara, 28100

Novartis Investigative Site
Orbassano, 10043

Novartis Investigative Site
Palermo, 90127

Novartis Investigative Site
Palermo, 90146

Novartis Investigative Site
Pescara, 65124

Novartis Investigative Site
Perugia, 06100

Novartis Investigative Site
Pisa, 56126

Novartis Investigative Site
Reggio Emilia, 42123

Novartis Investigative Site
Roma, 00144

Novartis Investigative Site
Roma, 00161

Novartis Investigative Site
Roma, 00168

Novartis Investigative Site
Roma, 00161

Novartis Investigative Site
Salerno, 84131

Novartis Investigative Site
Siena, 53100

Novartis Investigative Site
Torino, 10126

Novartis Investigative Site
Torino, 10128

Novartis Investigative Site
Perugia, 06100

Novartis Investigative Site
Verona, 37126