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

Type of study

Therapy optimization trial

Current status

Recruiting

Study title

Therapies in Combination or Sequentially With Tyrosine Kinase Inhibitors (TKIs) in Chronic Phase Chronic Myelogenous Leukemia Patients in Complete Cytogenic Remission (CCR) (ACTIW) [France]

Scientific title

Candidate Therapies in Combination or Sequentially With Tyrosine Kinase Inhibitors in Chronic Phase Chronic Myelogenous Leukemia Patients in CCR Without Achieving a Deep Molecular Response: an Adaptative Trial Based on a Drop Loser Design (ClinicalTrials.gov NCT02767063)

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).

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.

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

Key inclusion criteria

This study includes patients who:
– are at least 18 years old
– have 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 achieved complete cytogenetic response (CCR) (BCR-ABL less than or equal 1% on the International Scale)
– have an Eastern Co-Operative Group (ECOG) status of 0-2
– have adequate liver and kidney function

Key exclusion criteria

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 sponsor

Hôpitaux de Versailles, Hôpital Mignot, France

Scientific lead / contact

Pr Philippe Rousselot
Centre Hospitalier de Versailles
France

Principal investigator

Pr Philippe Rousselot
Centre Hospitalier de Versailles
France

Study centers / principal investigators

France

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

Annecy
Prinicpal Investigator: Pascale Cony-Makhou

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

Bordeaux, 33076
Institut Bergonié
Prinicpal Investigator: Gabriel Etienne

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

Clermont-Ferrand
CHU Estaing
Prinicpal Investigator: Marc Berger

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

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

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

Limoges
CHU de Limoges
Prinicpal Investigator: Amélie Penot

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

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

Nantes, 44035
Service d’Hémato-Cancérologie
CHU Hôtel-Dieu
Prinicpal 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