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
Type of study
Therapy optimization trial
Phase
Current status
It is unknown whether the trial is still recruiting participants.
Other trial ID
P13/12_ACTIW; ClinicalTrials.go 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).
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
This study does not include patients who:
- have a history of hematopoietic stem cell transplantation (autologous or allogenic)
- have cardiovascular disease as defined in the study protocol.
Further criteria may apply. Please discuss these with your doctor or study staff.
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 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
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