ACTIW = Therapies in Combination or Sequentially with TKIs in CML-CP Patients in Complete Cytogenic Remission [France]

What is the purpose of the study

The purpose of this study is to evaluate whether combination of a tyrosine kinase inhibitor (TKI) with another study drug can help achieve deep response (MR4.5).

The first arm (TKI alone versus TKI + combination with pioglitazone) has been completed.

Additional treatment groups with other combinations are planned and include:

• a TKI in combination with avelumab
• a TKI in combination with pegylated interferon
• a TKI in combination with arsenic trioxide
• a TKI in combination with Homoharringtonine
• a TKI in combination with anti-PD-L1 antibody

What will happen during the study

Patients will receive either a TKI alone (imatinib, nilotinib, dasatinib, bosutinib or ponatinib at the same daily dose and schedule as during the last 3 months before inclusion in the study) or a TKI (imatinib, nilotinib, dasatinib, bosutinib or ponatinib at the same daily dose and schedule as during the last 3 months before inclusion in the study) in combination with another drug.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged 18 years or older
• have been diagnosed with Philadelphia chromosome positive (Ph+) and BCR-ABL1+ chronic myeloid leukemia in chronic phase (CP-CML)
• have been treated imatinib, nilotinib, dasatinib, bosutinib or ponatinib for more than 2 years overall
• have not switched between tyrosine kinase inhibitors within the last 3 months
• have had not dose changes in the last 3 months
• have achieved complete cytogenetic response (CCyR) (BCR-ABL less than or equal 1% on the International Scale)
• have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
• have adequate liver and kidney function.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

Estimated primary completion date

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study centers / principal investigators

France

Angers, 49033
Service de Médecine D
CHU d’Angers
Prinicipal Investigator: Martine Gardembas

Annecy
Principal Investigator: Pascale Cony-Makhou

Bobigny, 93000
Service Hématologie
Hôp Avicenne
Principal Investigator: Thorsten Braun

Bordeaux, 33076
Institut Bergonié
Principal Investigator: Gabriel Etienne

Caen
CHU Côte de Nacre
Principal Investigator: Hyacynthe Johnson-Ansah

Clermont-Ferrand
CHU Estaing
Principal Investigator: Marc Berger

Créteil, 94010
Service Hématologie Clinique et Thérapie Cellulaire
CHU Henri Mondor
Principal Investigator: Lydia Roy

Le Chesnay, 78157
Centre Hospitalier de Versailles
Hôpital André Mignot
Service de Médecine B Hématologie-Oncologie
Principal Investigator: Pr Philippe Rousselot (Coordinating Investigator)

Lille, 59037
Service des Maladies du Sang
Hôpital Claude Huriez
Principal Investigator: Valérie Coiteux

Limoges
CHU de Limoges
Principal Investigator: Amélie Penot

Lyon, 69374
Service d’Hématologie
Hôpital Edouard Herriot
Principal Investigator: Franck Nicolini

Marseilles, 13273
Service Hématologie
Institut Paoli Calmette
Principal Investigator: Aude Charbonnier

Nantes, 44035
Service d’Hémato-Cancérologie
CHU Hôtel-Dieu
Principal Investigator: Viviane Dubruille

Nice
Hopital l’Archet
Principal Investigator: Eric Jourdan

Nimes, 30029
Service de Hématologie Oncologie
CHU Caremeau
Principal Investigator: Eric Jourdan

Orleans, 45100
Service d’Onco-Hématologie
Hôpital La Source
Principal Investigator: Omar Benbrahim

Paris,75010
Centre D’investigations INSERM CIC9504
Hôpital St Louis
Principal Investigator: Delphine Rea

Paris, 75571
Service de Hématologie Oncologie
CHU St Antoine
Principal Investigator: Simona Lapusan

Poitiers, 86021
Département d’Hématologie et Oncologie et Inserm CIC 1402
CHU de Poitiers
Principal Investigator: Emilie Cayssials

Rennes, 35033
Service Hématologie
CHU de Rennes
Principal Investigator: Martine Escoffre-Barbe

Saint-Cloud
Hôpital René Huguenin
Principal Investigator: Sylvie Glaisner

Toulouse
Institut Universitaire contre le Cancer
Principal Investigator: Françoise HUGUET

Tours, 37000
Service Hémato-Oncologie
CHU de Tours
Principal Investigator: Caroline Dartigeas