PIO2STOP = Second STOP After Pioglitazone Priming in CML Patients [France]

Study title

Second STOP After Pioglitazone Priming in CML Patients(PIO2STOP) [France]

Scientific title

Combination study of pioglitazone and tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia patients after failure of a first TKI discontinuation attempt to in order to prepare a new stop (clinicaltrials.gov NCT02889003)

Indication and most important inclusion criteria

This study includes patients who:
- have chronic myeloid leukemia (CML) in any phase
- are at least 18 years old
- have been treated with imatinib, dasatinib, nilotinib or bosutinib before
- have discontinued tyrosine kinase inhibitor (TKI) treatment during a first stop trial and thereafter lost MMR
- have achieved deep molecular response (MR4.5)
- have adequate liver and kidney function

Short description of intervention

The purpose of this study is to evaluate whether the combination of pioglitazone with a tyrosine kinase inhibitor (TKI) is safe in patients who have lost major molecular response (MMR) after stopping a first TKI.

Study participants will be started on or continue with the same TKI and at the same dose as before discontinuation. They will also receive pioglitazone 30 mg once daily. After 2 months the pioglitazone dose will be increased to 45 mg once daily in patients who do not have any adverse events of grade 2 or worse.

Patients need to have achieved deep molecular response (MR4.5) before inclusion. They will receive pioglitazone and the TKI for 6 months in the study and will then have the option of stopping the combination treatment altogether. They will then be monitored for 2 years to see if they remain well without any treatment. Patients will be followed up for 5 years.

Type of study

Treatment discontinuation trial

Current status

Recruitment status unknown

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 centers / principal investigators

France

Le Chesnay, 78157
Centre Hospitalier de Versailles
Hôpital André Mignot
Service de Médecine B Hématologie-Oncologie
Pr Philippe Rousselot



TRAD = Treatment-free Remission Accomplished With Dasatinib in Patients With CML [Canada]

Study title

Treatment-free Remission Accomplished With Dasatinib in Patients With CML (TRAD) [Canada]

Scientific title

Treatment-free Remission Accomplished With Dasatinib in Patients With CML (TRAD) (ClinicalTrials.gov No. NCT02268370)

Indication and most important inclusion criteria

This study includes patients who:
- have chronic myeloid leukemia in chronic phase
- have been treated with first line imatinib for at least 3 years
- are in deep molecular remission (MR4.5) at study entry
- are at least 18 years old
- have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
- have adequate kidney and liver function

Short description of intervention

This trial will evaluate how safe and effective it will be for patients with chronic myeloid leukemia (CML) to discontinue first line treatment with imatinib.

Study participants will stop taking imatinib if they have reached deep molecular response after at least 3 years of treatment. They will then be monitored for up to 2.5 years to see if they remain well without any treatment at all. Patients who have a relapse will be given dasatinib for up to 2 years. Patients who achieve a response and maintain a response on dasatinib will have the option of discontinuing dasatinib.

Type of study

Treatment discontinuation trial

Current status

No longer recruiting

Study sponsor

University Health Network, Toronto, Canada

Scientific lead / contact

Dennis Kim, M.D., University Health Network, Toronto
Contact: Sima Bogomilsky

Principal investigator

Dennis Kim, M.D.
University Health Network
Toronto, Canada

Additional information

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

Study centers / principal investigators

Canada

Alberta
Calgary
Tom Baker Cancer Center
Donna Forrest, M.D.

Edmonton
University of Alberta Hospital
Elena Liew, M.D.


British Columbia
Vancouver
Vancouver General Hospital
Donna Forrest, M.D.


Manitoba
Winnigpeg
Cancer Care Manitoba
Kristjan Paulson, M.D.


Nova Scotia
Halifax
Queen Elizabeth II Health Sciences Centre
Stephen Couban, M.D.

Ontario
Hamilton
Juravinski Cancer Centre
Brian Leber, M.D.

London
London Health Sciences Centre
Anagyros Xenocostas, M.D.

Ottawa
Ottawa General Hospital
Isabelle Bence-Bruckler, M.D.

Toronto
Princess Margaret Cancer Centre
Jeffrey Lipton, M.D.


Quebec
Charlesbourg
Centre Hôpitallier Universitaire de Quebec - Hôpital de l'Enfant-Jésus
Robert Delage, M.D.

Montreal
Hopital Maisonneuve-Rosemont
Lambert Busque, M.D.

Montreal
McGill University Health Centre
Pierre Laneuville, M.D.

BOSTRO = CML Treated With Bosutinib After Relapse [Spain]

Study title

BOSTRO = CML Treated With Bosutinib After Relapse

Scientific title

Single Nucleotide Polymorphism Association With Response and Toxic Effects in Patients With Ph+ CP-CML Treated With Bosutinib After Relapse to Previous Treatment (NCT02445742, EudraCT 2013-004323-372013-004323-37)

Indication and most important inclusion criteria

This study includes patients who:
- have Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase (CP-CML)
- have not responded optimally to previous treatment with imatinib, nilotinib or dasatinib, defined as BCR-ABL above 10% at 3 months after starting treatment
- are at least 18 years old
- have recovered from any adverse effects of previous treatments, except for hair loss
- have an Eastern Co-Operative Group (ECOG) status of 0 or 1
- have adequate bone marrow, kidney and liver function

Short description of intervention

This study investigates whether specific features (so called single nucleotide polymorphisms) in genes are related to the activity and adverse effects of bosutinib. The study also evaluates the safety and efficacy of bosutinib in patients after relapse or intolerance to previous tyrosine kinase inhibitors (TKIs).

Patients who have not responded optimally to previous TKI treatment will receive bosutinib 500 mg per day for 2 years, until the disease progresses, unacceptable side effects occur or the patient withdraws consent to participate

Type of study

Second line trial after treatment failure

Current status

Recruiting

Study sponsor

Fundación PETHEMA para el tratamiento de la leucemia y el linfoma, Spain, with financial support from Pfizer, S.L.U.

Scientific lead / contact

Dr Luis Felipe Casado
PETHEMA

Principal investigator

Dr Luis Felipe Casado
PETHEMA

Additional information

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

Study centers / principal investigators

Spain

Gran Canaria
C. H. U. de Gran Canaria Dr. Negrín
Dr. Maite Gómez Casares

Madrid
C. H. Gregorio Marañón
Dr. Santiago Osorio

Madrid
C. U. La Paz - H. U. La Paz
Dr. Raquel de Paz

Madrid
H. Ramón y Cajal
Dr. J. Valentín García Gutiérrez

Madrid
H. U. de la Princesa
Dr. Juan Luis Steegmann

Madrid
H. U. Fundación Jiménez Díaz
Dr. José Luis López Lorenzo

Madrid
Hospital Universitario 12 de Octubre
Dr. Joaquin Martinez

Málaga
C. H. Regional de Málaga , H. General
Dr. Antonio Jiménez Velasco

Palma de Mallorca
H. U. Son Espases
Dr. Andrés Novo

Salamanca
C. Asistencial U. de Salamanca
Dr. Fermín Sánchez Guijo

Santiago de Compostela
C. H. U. de Santiago
Dr. Manuel Pérez Encinas

Toledo
H. Virgen de la Salud
Dr. Luis Felipe Casado

Zaragoza
Clínica Quirón Zaragoza S.A.
Dr. Pilar Giraldo

Prospective Registry of Ponatinib in Belgium [Belgium]

Study title

Prospective registry of ponatinib in clinical practice for CML or Ph+ ALL in Belgium

Scientific title

Prospective registry of Iclusig® (ponatinib) used in clinical practice for the treatment of patients with Chronic Myeloid Leukemia or CML or Ph+ Acute Lymphoblastic Leukemia in Belgium (ClinicalTrials.gov NCT03678454)

Indication and most important inclusion criteria

This registry will be open to all patients who:
- Received Iclusig® through the named patient program (NPP) prior to 01 March 2016 AND were still on Iclusig® treatment on 01 March 2016.
- Were put on Iclusig® treatment between 01 March 2016 and registry start.
- Will be put on Iclusig® treatment up to 3 years after reimbursement of Iclusig® in Belgium (01 March 2019).

Inclusion criteria:

1. Patients aged 18 years or older with a confirmed diagnosis of Chronic Myeloid Leukemia (CML) (chronic, accelerated or blast phase) who are resistant or intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation;
OR
Patients with a confirmed diagnosis of Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) who are resistant or intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation.
3. Patients on treatment with Iclusig® or who have been prescribed treatment with Iclusig® during the registry (treatment decisions should be taken outside the registry).

The patient must not be included in the registry if he/she is concurrently participating in a clinical study, at any time during the registry period, in which the patient is exposed to Iclusig® or to another investigational product/ vaccine (pharmaceutical product/ device).

Short description of intervention

This prospective registry aims to gather specific data on Iclusig® usage in routine practice on treatment dosage and duration up to 3 years after reimbursement in Belgium.

Secondary objectives are:
- To describe demographic and disease characteristics for patients with CML or Ph+aLL receiving Iclusig®.
- To describe Iclusig® treatment outcomes.
- To estimate the additional health care utilisation cost associated with the treatment of Iclusig® related adverse events reported during the registry

Type of study

Other trials

Current status

No longer recruiting

Study sponsor

Incyte Biosciences Benelux

ScientificIncyte Biosciences Benelux lead / contact

Study Director: Marcel Koopman, Incyte Biosciences Benelux

Principal investigator

There is no principal investigator as this is a registry.

Additional information

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

Study centers / principal investigators

Belgium

ZNA Stuyvenberg
Antwerpen, 2060

UZ Antwerpen
Antwerpen, 2650

AZ Klina
Brasschaat, 2930

AZ St-Jan Brugge
Brugge, 8000

Institut Jules Bordet
Brussels, 1000

CHU Brugmann
Brussels, 1020

Hopital Erasme
Brussels, 1070

UZ Brussel
Brussels, 1090

Clinique universitaires Saint-Luc
Brussels, 1200

Ziekenhuis Oost Limburg (ZOL)
Gent, 3600

Hopital Jolimont
Haine-Saint-Paul, 7100

Jessa Ziekenhuis
Hasselt, 3500

AZ Groeninge
Kortrijk, 8500

UZ Leuven
Leuven, 3000

CHU Sart Tilman Liège
Liège, 4000

CHU Charleroi Vésale
Montigny-le-Tilleul, 6110

AZ Turnhout St-Elisabeth
Turnhout, 2300

CHR La Tourelle
Verviers, 4800

CHU/UCL Namur Mont-Godinne
Yvoir, 5530

DASTOP-2 (CA180-655) = Second treatment stop [Denmark, Finland, France, Germany, Sweden, Norway, The Netherlands]

Study title

DASTOP-2 = A multicenter trial where patients with CML stop medication a second time

Scientific title

Persistence of major molecular remission in chronic myeloid leukemia after a second stop of TKI treatment in patients who failed an initial stop attempt: A prospective multicenter study (ClinicalTrials.gov NCT03573596; EudraCT 2016-004106-34, )

Indication and most important inclusion criteria

This study includes male or female patients who:

- are at least 18 years old
- have chronic myeloid leukemia (CML) in chronic phase (CP) with confirmed presence of the BCR/ABL1 gene
- who have had a molecular relapse after attempting to stop therapy with a tyrosine kinase inhibitor (TKI) within the EUROSKI study or outside the study but according to EUROSKI procedures. Patients who attempted stopping outside the study must have received a TKI for at least 3 years before the first stop, including dasatinib in this study during the last 2 years. Patients must have been in deep molecular response (MR4) for at least 1 year before stopping.
- who have been treated with any TKI for at least 1 year after having failed a first attempt to stop treatment with a TKI

Short description of intervention

The purpose of this study is to assess treatment-free remission (persistence of major molecular remission) after a second attempt to stop TKI treatment

Type of study

7. Treatment discontinuation trials

Current status

No longer recruiting

Study sponsor

Uppsala University Hospital, Sweden,
with financial support from BMS

Scientific lead / contact

Ulla Olsson-Strömberg, Uppsala University Hospital

Principal investigator

Ulla Olsson-Strömberg, Uppsala University Hospital

Additional information

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

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

Study centers / principal investigators

Denmark

Aarhus
Aarhus University Hospital
Jesper Stentoft

Odense
Odense University Hospital
Andreja Dimitrijevic (National Coordinator)

Finland

Helsinki
Department of Hematology Helsinki University Hospital
Satu Mustjoki (National Coordinator) and Perttu Koskenvesa


France

Créteil
Centre Hospitale-Universitaire, Créteil
Lydia Roy (National Coordinator)

More centers are going to join in France later.


Germany

Bonn
Lino Teichmann

Essen
Joachim Göthert

Mannheim
Susanne Saußele (National Coordinator)


Norway

Bergen
Haukeland University Hospital
Bjørn Tore Gjertsen

Oslo
Oslo University Hospital
Tobias Gedde Dahl

Stavanger
Stavanger University Hospital
Waleed Majeed (National Coordinator)

Tromsø
Tromsø University Hospital
Anders Vik

Trondheim
St Olavs Hospital-Trondheim University Hospital
Henrik Hjorth Hansen


Sweden

Linköping
Linköping University Hospital
Kourosh Lofti and Arta Dreimane

Luleå
Sunderby Sjukhus
Anneli Enblom-Larsson

Lund
Lund University Hospital
Johan Richter, Anna Lubking and Elena Holm

Örebro
Örebro University Hospital
Erik Ahlstrand

Stockholm
Karolinska Hospital
Leif Stenke and Lotta Ohm

Umeå
Umeå University Hospital
Berit Markevärn

Uppsala
Uppsala University Hospital (Akademiska)
Stina Söderlund, Ulla Olsson Strömberg (Principal Investigator)

The Netherlands


Amsterdam
Jeroen Janssen (National Coordinator)

Dordrecht
Peter Westerweel

Nijmegen
Nicole Blijlevens

Rotterdam
Peter Boekhorst

 

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

No longer 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


Subcategories

Please donate!

Please donate!

LogIn

EU e-Privacy Directive