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 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

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
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


 
   
 

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