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
DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]
Study title
DasaHIT = Dasatinib Holiday for Improved Tolerability
Scientific title
Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naive disease (1st line) and patients with resistance or intolerance against alternative Abl-Kinase Inhibitors (2nd line) (EudraCT 2015-003502-16)
Indication and most important inclusion criteria
This study includes patients aged 18 years and above who have been newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemie (CML) in any phase or who have failed treatment or are intolerant to previous treatment with other tyrosine kinase inhibitors (TKI) (imatinib, nilotinib, bosutinib, ponatinib). To be included patients must also have a score of at least 2 on the ECOG performance scale assessing the quality of life of cancer patients.
Patients with Ph-negative CML or socalled variant translocations, who are BCR-ABL-positive, are also considered eligible for inclusion.
Short description of intervention
This study will investigate whether treatment with dasatinib over two years is equally effective when dasatinib is not given on weekends (treatment pause) compared to daily administration of dasatinib without treatment pauses.
Type of study
First-line trial, trial after therapy failure or intolerance, therapy optimization trial
Current status
recruiting
Study sponsor
Friedrich-Schiller-Universität Jena, Germany, with financial support from Bristol-Myers Squibb
Scientific lead / contact
Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
Germany
Principal investigator
Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
Germany
Additional information
Study centers / principal investigators
Germany
Uniklinik der RWTH Aachen
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Aachen
Gesundheitszentrum St. Marien GmbH
Amberg
Gemeinschaftspraxis
Dr. med. Hans R. Slawik
Martin Deuringer
Dr. med. Margarete Plath
Augsburg
Studienzentrum Aschaffenburg
Aschaffenburg
Internistische FA-Praxis Prof. Josting
Berlin
Evangelisches Klinikum Bethel gGmbH
Klinik für Innere Medizin, Hämatologie|Onkologie und Palliativmedizin
Bielefeld
Universitätsklinikum Bonn
Bonn
Klinikum Bremen Mitte gGmbH
Bremen
Klinikum Chemnitz
Chemnitz
Gemeinschaftspraxis Mohm
Dresden
Universitätsklinikum Carl Gustav Carus
Dresden
HELIOS St. Johannes Klinik Duisburg
Duisburg
Gemeinschaftspraxis
Dr. M. Eckart und Dr. B. Häcker
Erlangen
Universitätsklinikum Essen
Essen
Universitätsklinikum
Freiburg
Klinikum Goch
Goch
MVZ Onkologische Kooperation Harz
Hämatologie und Internistische Onkologie
Dr. med Mark-Oliver Zahn
Goslar
ConMed GmbH
Göttingen
Hämato-Onkologische Gemeinschaftspraxis Halberstadt
Halberstadt
Universitätsklinikum
Halle/S.
MediProjekt GbR Hannover
Hannover
St. Bernward Krankenhaus Hildesheim
Medizinische Klinik II / MVZ Onkologie
Hildesheim
Universitätsklinikum Jena
Jena
IDGGQ
Kaiserslautern
Onkolog. Schwerpunktpraxis, Dres. Richard Hansen, Susanne Pfitzner-Dempfle, Manfred Reeb
Kaiserslautern
Städt. Klinikum Karlsruhe
Karlsruhe
St. Vincentius-Kliniken Karlsruhe
Medizinische Klinik 2
Hämatologie, Onkologie, Immunologie, Palliativmedizin
Karlsruhe
Klinikum Kassel
Hämatologie/Onkologie/Immunologie
Kassel
Onkologische Gemeinschaftspraxis
Dr. med. Siegfried Siehl
Dr. med. Ulrike Söling
Kassel
Städtisches Krankenhaus Kiel
Kiel
Universitätsklinikum SH
Kiel
Institut für Versorgungsforschung in der Onkologie GbR
Koblenz
Gemeinschaftspraxis für Hämatologie und Onkologie
Prof. Dr. med. Stephan Schmitz
Dr. med. Tilmann Steinmetz
Dr. med. Kai Severin
Köln
MVZ Hämatologie und Onkologie
Krefeld
Onkologisches Zentrum
Gemeinschaftspraxis für Hämatologie und Onkologie
Im Caritas Krankenhaus
Lebach
2nd site: Saarlouis
Studienzentrum UnterEms
MVM mbH
Leer
2nd site: Onkologie UnterEms
Emden
Universität Leipzig
Leipzig
Gemeinschaftspraxis
Dres. Müller, Kröning, Jentsch-Ullrich, Tietze und Krogel
Magdeburg
Universitätsmedizin Mannheim
Mannheim
Universitätsklinikum Gießen und Marburg GmbH
Standort Marburg
Rotkreuzklinikum
München
Schick Hämatologisch-Onkologische Praxisgemeinschaft
München
Medizinische Klinik A (Hämatologie, Hämostaseologie, Onkologie und Pneumologie)
Münster
Stauferklinikum Schwäbisch Gmünd
Mutlangen
Hämatologisch-onkologische Schwerpunktpraxis
Neustadt a. Rbge
Klinikum Passau
Passau
Kreisklinikum Reutlingen
Reutlingen
Klinikum Südstadt Rostock
Rostock
Hämatologie-Onkologie Stolberg
Stolberg
Universitätsklinikum Ulm
Ulm
Klinikum der Stadt Villingen-Schwenningen
Villingen-Schwenningen
Rems-Murr-Klinik Winnenden
Onkologie und Palliativmedizin
Winnenden
ASC4MORE (CABL001E2201) = A Phase II Study of ABL001 in Patients With CML-CP without Deep Molecular Response [Asia, Australia, Europe, North America, South America]
Study title
ASC4MORE (CABL001E2201) = A Phase II Study of Asciminib in Combination With Imatinib for Patients with CML-CP without Deep Molecular Response
Scientific title
A phase 2, multi-center, open-label, randomized study of oral asciminib added to imatinib versus continued imatinib versus switch to nilotinib in patients with CML-CP who have been previously treated with imatinib and have not achieved deep molecular response (EudraCT 2018-001594-24, ClinicalTrials.gov NCT03578367)
Indication and most important inclusion criteria
Male or female patients 18 years and older with Philadelphia chromosome-positive CML in chronic phase who previously received first line treatment with imatinib. Patients can be considered for inclusion in the study if they have BCR-ABL results of more than 0.1% and up to 1% on the international scale (IS) at the screening examination and did not reach deep molecular response (MR4 or better) at any time during prior imatinib treatment. To be eligible for inclusion, patients must have acceptable laboratory values at screening, electrolytes within normal limits, and adequate end-organ function.
Short description of intervention
This is a study of the efficacy and safety of asciminib in addition to imatinib compared to continued imatinib or compared to nilotinib in pre-treated CML-CP patients without a deep level of molecular response on imatinib.
Type of study
Therapy optimization trial
Current status
recruiting
Study sponsor
Novartis Pharmaceuticals
Scientific lead / contact
Novartis Pharmaceuticals
Principal investigator
Novartis Pharmaceuticals
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
Australia
New South Wales
Novartis Investigative Site
Darlinghurst, 2010
South Australia
Novartis Investigative Site
Adelaide, 5000
Victoria
Novartis Investigative Site
Melbourne, 3000
Austria
Novartis Investigative Site
Graz, 8036
Novartis Investigative Site
Vienna, 1140
Canada
Novartis Investigative Site
Montreal, H1T 2M4
Chile
Novartis Investigative Site
Temuco, Araucania, 4810469
Novartis Investigative Site
Vina del Mar, Valparaiso, 2540364
Czech Republic
Novartis Investigative Site
Brno - Bohunice, 639 01
Denmark
Novartis Investigative Site
Herlev, DK 2730
France
Novartis Investigative Site
Bordeaux, 33076
Germany
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Dresden; 01307
Novartis Investigative Site
Mannheim, 68305
Hong Kong
Novartis Investigative Site
Hong Kong
Italy
Novartis Investigative Site
Milano, 20162
Novartis Investigative Site
Roma, 00161
Korea, Republic of
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Novartis Investigative Site
Seoul, 03080
Poland
Novartis Investigative Site
Krakow, 31 531
Novartis Investigative Site
Warszawa, 02 776
Novartis Investigative Site
Wroclaw, 50 367
Portugal
Novartis Investigative Site
Lisboa, 1099 023
Novartis Investigative Site
Porto, 4200-072
Russian Federation
Novartis Investigative Site
Moscow, 125167
Novartis Investigative Site
Moscow, 115284
Novartis Investigative Site
Saint Petersburg, 191024
Novartis Investigative Site
Saint Petersburg, 197341
Spain
Novartis Investigative Site
Sevilla, 41009
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Valencia, 46026
Taiwan
Novartis Investigative Site
Changhua, 50006
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taoyuan, 33305
United Kingdom
Novartis Investigative Site
London, W12 0HS
Novartis Investigative Site
Oxford, OX3 7LJ
Novartis Investigative Site
Wirral, Merseyside, CH63 4JY
USA
Georgia
Georgia Regents University
Augusta, 30912
Illinois
University of Chicago
Chicago, 60637
Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, 21205
S1712 = Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for CML [USA]
Study title
Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia (S1712)
Scientific title
A Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination With BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) (clinicaltrials.gov NCI-2017-02066; NCT03654768)
Indication and most important inclusion criteria
This study includes patients who:
- are at least 18 years old
- have been diagnosed with chronic phase chronic myeloid leukemia (CML-CP) without any history of progression to accelerated or blast phase CML
- have been receiving treatment with dasatinib or nilotinib as first or second line therapy for a minimum of 6 months prior to registration
- have not received more than 2 tyrosine kinase inhibitors (TKIs) for treatment of CML (hydroxyurea prior to initiation of TKI is allowed)
- have been on their current TKI for a minimum of 6 months prior to randomization
- are expected to remain on the same TKI for the next 12 months
- have adequate liver and kidney function
Other criteria may apply. Please consult your doctor for further details.
Short description of intervention
This study assesses how well ruxolitinib phosphate and dasatinib or nilotinib work in treating patients with chronic myeloid leukemia. Ruxolitinib, dasatinib, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Type of study
Therapy optimization trial
Current status
Recruiting
Study sponsor
Southwest Oncology Group
National Cancer Institute (NCI)
Portland, Oregon, USA
Scientific lead / contact
Kendra L. Sweet, MD
Principal investigator
Kendra L. Sweet, MD
Additional information
Study centers / principal investigators
United States
Southwest Oncology Group
National Cancer Institute (NCI)
Kendra L. Sweet, MD
Portland, Oregon 97239
For details on 517 study locations see study information at clinicaltrials.gov