coiaward2010

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

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)

Indication and most important 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

Short description of intervention

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 pioglitazone.

Additional treatment groups with other combinations are planned for the future. They 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

Type of study

Therapy optimization trial

Current status

Recruiting

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

Additional information

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

Study centers / principal investigators

France

Angers, 49033
Service de Médecine D
CHU d'Angers
Dr Martine Gardembas

Bobigny, 93000
Service Hématologie
Hôp Avicenne
Dr Thorsten Braun

Bordeaux, 33076
Institut Bergonié
Dr Gabriel Etienne

Creteil,, 94010
Service Hématologie Clinique et Thérapie Cellulaire
CHU Henri Mondor
Dr Lydia Roy

La Source Orleans, 45100
Service d'Onco-Hématologie
Hôpital La Source
Dr Omar Benbrahim

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

Lille, 59037
Service des Maladies du Sang
Hôpital Claude Huriez
Dr Valérie Coiteux

Lyon, 69374
Service d'Hématologie
Hôpital Edouard Herriot
Dr Franck Nicolini

Marseilles, 13273
Service Hématologie
Institut Paoli Calmette
Dr Aude Charbonnier

Nantes, 44035
Service d'Hémato-Cancérologie
CHU Hôtel-Dieu
Dr Viviane Dubruille

Nimes, 30029
Service de Hématologie Oncologie
CHU Caremeau
Eric Jourdan

Paris,75010
Centre D'investigations INSERM CIC9504
Hôpital St Louis
Dr Delphine Rea

Paris, 75571
Service de Hématologie Oncologie
CHU St Antoine
Dr Simona Lapusan

Poitiers, 86021
Département d'Hématologie et Oncologie et Inserm CIC 1402
CHU de Poitiers
Dr Emilie Cayssials

Pringy, 74370
Service d'Hématologie
Centre Hospitalier Annecy Genevois
Dr Pascale Cony.Makhoul

Rennes, 35033
Service Hématologie
CHU de Rennes
Dr Martine Escoffre-Barbe

Tours, 37000
Service Hémato-Oncologie
CHU de Tours
Dr Caroline Dartigeas