ACTIW = Therapies in Combination or Sequentially with TKIs in CML-CP Patients in Complete Cytogenic Remission [France]
Type of study
Therapy optimization trial
Phase
Current status
It is unknown whether the trial is still recruiting participants.
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
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