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
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

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

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

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

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

Short protocol

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 screeing, 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


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
Bologna, 40138

Novartis Investigative Site
Milano, 20162


Japan

Novartis Investigative Site
Shinagawa ku, Tokyo, 141 8625

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
Las Palmas de Gran Canaria, 35010

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

Illinois
University of Chicago
Chicago, 60637

Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, 21205

Saint Agnes Healthcare Cancer Institute
Baltimore, 21229

New York
SUNY- Stony Brook Medical Oncology Hematology/Oncology
Stony Brook, 11794-8174

Texas
University of Texas MD Anderson Cancer Center
Houston, 77030

S1712 = Ruxolitinib Phosphate and Dasatinib or Nilotinib in Treating Patients With Chronic Myeloid Leukemia [USA]

Study title

Ruxolitinib Phosphate and Dasatinib or Nilotinib in Treating Patients With 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)

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

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