KISS = Kinase Inhibition With Sprycel Start up [New Zealand]

Study title

KISS: Kinase Inhibition With Sprycel Start up

Scientific title

KISS Study: A Phase II Study of Dasatinib Followed by Imatinib in Newly Diagnosed, Previously Untreated Patients With Chronic Phase CML (ClinicalTrials.gov NCT03193281)

Indication and most important inclusion criteria

This study includes male or female patients who:

- are at least 18 years old
- have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
- have been diagnosed with chronic myeloid leukemia in chronic phase within 3 months of enrolment
- have cytogenetic or molecular confirmation of Philadelphia chromosome (Ph+) or variants of (9;22) translocations

Short description of intervention

This study will assess the efficacy and safety of a treatment plan for patients with newly diagnosed CML-CP. In the first study stage, patients will be given dasatinib (Sprycel) to more rapidly induce a molecular response (MR3.0). At 13 months, patients will be switched to imatinib to maintain CML in that remission.
Patients who do not achieve confirmed MR3.0 at 13 months will not be eligible to switch to imatinib treatment and will continue on dasatinib treatment.

Type of study

First line trial

Current status

Recruiting

Study sponsor

University of Auckland, New Zealand, in collaboration with Leukaemia & Blood Cancer, New Zealand

Scientific lead / contact

Professor Peter Browett, University of Auckland, New Zealand

Principal investigator

Professor Peter Browett, University of Auckland, New Zealand

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

New Zealand

Auckland City Hospital
Auckland
Principal Investigator: Prof Peter Browett

Middlemore Hospital
Auckland
Principal Investigator: Dr Gordon Royle

Christchurch Hospital
Christchurch
Principal Investigator: Dr Emma Jane McDonald

Dunedin Hospital
Dunedin
Principal Investigator: Dr Lucy Pemberton

Waikato Hospital
Hamilton
Principal Investigator: Humphrey Pullon

Taranaki Base Hospital
New Plymouth
Principal Investigator: Bart Baker

Palmerston North Hospital
Palmerston North
Principal Investigator: Bart Baker

North Shore Hospital
Takapuna
Principal Investigator: Henry Chan

Wellington Hospital
Wellington
Principal Investigator: Victoria Campion

 

TIPI = Ponatinib followed by Imatinib in Chronic Phase Chronic Myeloid Leukemia [France]

Study title

Safety and Efficacy of Ponatinib Followed by Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (ET18000120; TIPI)

Scientific title

A Multicentre, Open-label Phase II Trial Evaluating the Safety and Efficacy of Ponatinib Induction Followed by Imatinib Maintenance in Adult Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) ≤ 65 Years (ClinicalTrials.gov no NCT04070443)

Indication and most important inclusion criteria

This study includes patients aged 18 to 65 years who were diagnosed with Philadelphia chromosome-positive (Ph+) with or without additional chromosomal abnormalities and/or BCR-ABL positive chronic myeloid leukemia (CML) in chronic phase (CP) within the past 3 months. Except for hydroxyurea and/or anagrelide, patients must have received no prior treatment for CML. To be eligible for inclusion, patients must also have a an intermediate or high EUTOS long-term survival Score. Kidney and liver function must be adequate.

Other criteria may apply.

Short description of intervention

This study is conducted to evaluate the safety, clinical and biological activity of an induction treatment with ponatinib 30 mg/day for 6 months, followed by a consolidation treatment with imatinib 400 mg/day in newly diagnosed de novo chronic phase CML patients.

The aim is to determine whether this treatment sequence increases the rate of patients reaching a stable MR4.5 allowing discontinuation of imatinib treatment.

Type of study

First line trials

Current status

Recruiting

Study sponsor

Centre Léon Bérard

Scientific lead / contact

Franck-Emmanuel NICOLINI, MD
Centre Léon Bérard

Principal investigator

Franck-Emmanuel NICOLINI, MD
Centre Léon Bérard

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

CHU Amiens Picardie
Amiens, 80000
Principal Investigator: Amandine Charbonnier, MD

CHU d'Angers
Angers
Principal Investigator: Martine Gardemba-Pain, MD

Centre Hospitalier Annecy-Genevois
Annecy, 74000
Principal Investigator: Anne Parry, MD

CH d'Avignon
Avignon, 84000
Principal Investigator: Hacène Zerazhi, MD

Chru Besançon
Besançon, France, 25000
Principal Investigator: Marion Simonet-Boissard, MD

Institut Bergonie
Bordeaux, 33000
Principal Investigator: Gabriel Etienne, MD

Chru Brest
Brest
Contact: Jean-Christophe IANOTTO, MD

Institut D'Hematologie de Basse Normandie
Caen, 14000
Principal Investigator: Hyacinthe Atchroué Johnson-Ansah, MD

CHU D'Estaing
Clermont-Ferrand, 63000
Principal Investigator: Marc Berger, MD

Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91000
Principal Investigator: Bertrand Joly, MD

Hopital Henri Mondor
Créteil, 94000
Principal Investigator: Lydia Roy, MD

CHU de Grenoble
Grenoble, 38000
Principal Investigator: Stéphane Courby, MD

CH de Versailles - Hôpital André Mignot
Le Chesnay
Principal Investigator: Philippe Rousselot, MD

Hôpital Claude Huriez - CHRU de Lille
Lille
Principal Investigator: Valérie Coiteux, MD

CHU Limoges - Hôpital Dupuytren
Limoges
Principal Investigator: Pascal Turlure, MD

Centre Léon Bérard
Lyon, 69008
Principal Investigator: Franck-Emmanuel Nicolini, MD

Hopital Saint Eloi
Montpellier, 34000
Principal Investigator: Philippe Quittet, MD

Chu Hotel Dieu
Nantes, 44000
Principal Investigator: Viviane Dubruille, MD

CHU Nîmes Caremeau - Institut de Cancérologie du Gard
Nîmes
Principal Investigator: Eric Jourdan, MD

Hopital Saintantoine
Paris, 75000
Principal Investigator: Simona Lapusan, MD

CHU Poitiers
Poitiers
Principal Investigator: José Miguel Torregrosa-Diaz, MD

CHU - Hopital de Pontchaillou
Rennes, 35000
Principal Investigator: Martine Escoffre-Barbe, MD

Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez
Principal Investigator: Denis Guyotat, MD

Institut de cancérologie Strasbourg Europe
Strasbourg, 67000
Principal Investigator: Shanti Natarajan-Ame, MD

Iuct Toulouse - Oncopole
Toulouse
Principal Investigator: Françoise Huguet, MD

CHRU Nancy/Brabois
Vandœuvre-lès-Nancy, 54500
Principal Investigator: Agnès Guerci-Bresler, MD

Hopital Paul Brousse
Villejuif, France, 94800
Principal Investigator: Laurence Legros, MD

 

Nilotinib20190426 = Nilotinib for First-line Newly Diagnosed CML-CP [China]

Study title

Nilotinib for First-line Newly Diagnosed CML-CP Patients

Scientific title

Efficacy and Safety of Nilotinib as the First-line Treatment for Patients With Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia: a Prospective Study (ClinicalTrials.gov NCT03942094)

Indication and most important inclusion criteria

This study includes male or female patients who:

- are at least 18 years old
- have been newly diagnosed with chronic myeloid leukemia (CML) in chronic phase (CP) within 6 months of study entry
- have positive Philadelphia chromosome (Ph+) CML or positive BCR-ABL1 (M-bcr transcript)
- are expected to receive treatment with imatinib within 2 weeks 
- have received no other CML treatment except for hydroxyurea and/or anagrelide and/or who have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2 
- have adequate organ function

Other criteria may apply.

Short description of intervention

This study will evaluate the efficacy and safety of nilotinib as the first-line treatment for adult patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP).

All study participants will receive nilotinib 300 mg twice a day. Study participants will be treated and/or followed for 18 months. At this time point, the rate of patients obtaining molecular response (MR) 4.5 will be assessed.

Type of study

First line trial

Current status

recruiting

Study sponsor

Shenzhen Second People's Hospital

Collaborators:

Zhongshan City People's Hospital
Affiliated Hospital of Guangdong Medical University
Huazhong University of Science and Technology Union Shenzhen Hospital
Dongguan People's Hospital
Longgang District Central Hospital of Shenzhen

Scientific lead / contact

Xin Du, PhD
Shenzhen Second People's Hospital

Principal investigator

Xin Du, PhD
Shenzhen Second People's Hospital

Additional information

Study description in the US register ClinicalTrials.govClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

China

Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Contact: Xin Du, PhD

FAsciNation = Frontline Asciminib Combination in Chronic Phase CML (CML XI) [Germany]

Study title

FAsciNation = Frontline Asciminib Combination in Chronic Phase CML (CML XI)

Scientific title

Frontline Asciminib Combination in Chronic Phase CML (ClinicalTrials.gov NCT03906292, EudraCT 2018‐002256‐33)

Indication and most important inclusion criteria

This study includes male or female patients who:

- are at least 18 years old
- have been diagnosed with Philadelphia chromosome positive (Ph+) and/or BCR-ABL1 positive chronic myeloid leukemia (CML) in chronic phase (CP) within 3 months of study entry
- have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2

- Pretreatment is allowed with hydroxyurea for up to 4 weeks or with nilotinib 300 mg twice daily, imatinib 400 mg once daily or dasatinib 100 mg once daily for up to 6 weeks. Patients without any treatment for CML within 6 weeks of screening are also eligible for recruitment.

Other criteria may apply.

Short description of intervention

Within 3 months of diagnosis, patients will be treated initially for 12 weeks with standard of care. If this is well tolerated, standard of care will be combined with asciminib at different doses (60 mg once daily, 20 mg twice daily, 40 mg twice daily or 80 mg once daily). The aim is to improve quality of life and treatment adherence.

Type of study

First line trial

Current status

Recruiting

Study sponsor

Thomas Ernst, PD Dr. med.
University of Jena

in collaboration with:

Ludwig-Maximilians - University of Munich
Novartis Pharmaceuticals

Scientific lead / contact

Thomas Ernst, PD Dr. med.
University of Jena

Principal investigator

Thomas Ernst, PD Dr. med.
University of Jena

Additional information

Study description in the US register ClinicalTrials.govClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Germany

Universitätsklinikum Aachen Medizinische Klinik IV
Dr. med. Martina Crysandt
52074 Aachen

Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln
Prof. Dr. Maike de Wit
12351 Berlin

Charite Universitätsmeditin Berlin
Campus Virchow Klinikum
Prof. Dr. Philipp le Coutre
13353 Berlin

Universitätsklinikum Bonn
Dr. med. Lino Teichmann
53105 Bonn

Klinikum Bremen Mitte gGmbH
Dr. med. Matthias Bormann
28177 Bremen

Klinikum Chemnitz GmbH
PD Dr. Mathias Hänel
09113 Chemnitz

GOKOS GmbH
PD Dr. med. Thomas Illmer
01307 Dresden

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dr. med. Franziska Taube
01307Dresden

Universitätsklinikum Erlangen
Prof. Dr. Stefan Krause
91054 Erlangen

St.-Antonius-Hospital Eschweiler
PD Dr. Peter Staib
52249 Eschweiler

Universitätsklinikum Essen
PD Dr. Joachim Göthert
45122 Essen

Universitätsklinikum Frankfurt
Dr. med .Fabian Lang
60590 Frankfurt

Universitätsklinikum Freiburg
Prof. Dr. Cornelius Waller
79106 Freiburg

Universitätsklinikum Jena
PD Dr. Thomas Ernst
07747 Jena

Universitätsklinikum Leipzig
Dr. med. Georg-Nikolaus Franke
04103 Leipzig

Gemeinschaftspraxis
Dres. Müller, Kröning, Jentsch-Ullrich, Tietze, Krogel
Prof. Dr. Kathleen Jentsch-Ullrich
39104 Magdeburg

Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
Prof. Dr. Markus Radsak
55131 Mainz

Universitätsmedizin Mannheim
Prof. Dr. Susanne Saußele
68169 Mannheim

Universitätsklinikum Gießen und Marburg GmbH
Prof. Dr. Andreas Burchert
35043 Marburg

Klinikum rechts der Isar
Dr. med. Peter Herhaus
81675 München

Brüderkrankenhaus St. Josef Paderborn
Dr. med. Tobias Gaska
33098 Paderborn

Krankenhaus Barmherzige Brüder Regensburg
Dr. med. Michael Schenk
93049 Regensburg

Universitätsklinikum Ulm
PD Dr. Frank Stegelmann
89081 Ulm

ASC4FIRST (CABL001J12301) = Oral Asciminib Versus Other TKIs in Newly Diagnosed Ph+ CML-CP [Asia-Pacific, Australia, Europe, North America]

Study title

ASC4FIRST (CABL001J12301) = A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Scientific title

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (ClinicalTrials.gov NCT04971226)

Indication and most important inclusion criteria

This study includes male or female patients 18 years and older who have been diagnosed with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP) within 3 months of study entry.

Eligible patients will meet laboratory values specified in the study protocol.

Additional criteria may apply.

Short description of intervention

This is a study to compare the efficacy of asciminib 80 mg once daily with Investigator selected TKI for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be either imatinib 400 mg once daily or nilotinib 300 mg twice daily or dasatinib 100 mg once daily or bosutinib 400 mg once daily .

Type of study

First line 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

Novartis Investigative Site
Kingswood, New South Wales, 2747

Novartis Investigative Site
Port Macquarie, New South Wales, 2444

Austria

Novartis Investigative Site
Linz, 4010

Novartis Investigative Site
Vienna, 1090


Canada


Novartis Investigative Site
Hamilton, Ontario, L8V 1C3

Novartis Investigative Site
Toronto, Ontario, M5G 2M9


China


Novartis Investigative Site
Nantong, Jiangsu, 226000

Novartis Investigative Site
Shenzhen, Guangdong, 518037

Novartis Investigative Site
Tianjin, Tianjin, 300020


Czechia


Novartis Investigative Site
Brno Bohunice, 625 00

Novartis Investigative Site
Ostrava Poruba, 708 52

Novartis Investigative Site
Hradec Kralove, 500 05


France

Novartis Investigative Site
Bordeaux, 33076

Novartis Investigative Site
Lyon Cedex, 69373

Novartis Investigative Site
Nantes Cedex 1, 44093

Novartis Investigative Site
Paris Cedex, 75475


Germany


Novartis Investigative Site
Aachen, 52074

Novartis Investigative Site
Berlin, 13353

Novartis Investigative Site
Frankfurt, 60590

Novartis Investigative Site
Jena, 07740

Novartis Investigative Site
Lübeck, 23538

Novartis Investigative Site
Mannheim, 68305


Hungary


Novartis Investigative Site
Debrecen, 4032

Novartis Investigative Site
Kaposvar, 7400

Novartis Investigative Site
Kecskemet, 6001


Italy


Novartis Investigative Site
Verona, 37126


Japan


Novartis Investigative Site
Akita, 010-8543

Novartis Investigative Site
Fukushima City, 960 1295

Novartis Investigative Site
Toyoake City, 470 1192

Novartis Investigative Site
Yamagata, 990 9585


Korea, Republic of

Novartis Investigative Site
Seoul, 03080

Novartis Investigative Site
Seoul, 03722

Novartis Investigative Site
Uijeongbu si, Gyeonggi Do, 11759


Malaysia

Novartis Investigative Site
Kuantan, 25100

Novartis Investigative Site
Pulau Pinang, 10990

Novartis Investigative Site
Selangor, 68000

Novartis Investigative Site
Subang Jaya, 47500


Norway


Novartis Investigative Site
Oslo, 0372

Novartis Investigative Site
Trondheim, 7006


Russian Federation

Novartis Investigative Site
Moscow, 127644

Novartis Investigative Site
Saint Petersburg, 191024


Singapore

Novartis Investigative Site
Singapore, 119228

Novartis Investigative Site
Singapore, 169608


Slovakia


Novartis Investigative Site
Bratislava, 83310

Novartis Investigative Site
Kosice, 040 66


Spain

Novartis Investigative Site
Barcelona, 08035

Novartis Investigative Site
El Palmar, 30120

Novartis Investigative Site
Granada, 18014

Novartis Investigative Site
Madrid, 28041

Novartis Investigative Site
Pamplona, 31008

Taiwan

Novartis Investigative Sie
Taichung, 40447

United Kingdom

Novartis Investigative Site
London, W12 0HS


United States

Colorado

Rocky Mountain Cancer Center
Denver, Colorado, 80501
Principal Investigator: David J Andorsky

Illinois

Illinois Cancer Care P.C. IL Cancer Specialists
Chicago, Illinois, 61615-7828
Principal Investigator: Leonard Klein

Ohio

Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
Principal Investigator: Edward R Broun

Oregon

Williamette Cancer Center
Eugene, Oregon, 97401
Principal Investigator: Luke Fletcher

Texas

Texas Oncology Texas Onc - Amarillo
Dallas, Texas, 75246
Principal Investigator: Praveen Kumar Tumula

Texas Oncology-Baylor USO
Dallas, Texas, 75246
Principal Investigator: Moshe Levy

Texas Oncology P A Austin
Dallas, Texas, 75251
Principal Investigator: Jason M Melear

US Oncology P A
Tyler, Texas, 75702

Virginia

Virginia Cancer Specialists
Gainesville, Virginia, 20155
Principal Investigator: Mitul Gandhi

Virginia Oncology Associates
Norfolk, Virginia, 23502
Principal Investigator: Celeste Bremer

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