NAUT (CAMN107ADE22T) = Efficacy of nilotinib in inducing persistence of molecular remission after second or third TKI stop [Europe]

Study title

Efficacy of nilotinib in inducing persistence of molecular remission after second or third TKI stop

Scientific title

Multicenter prospective trial after first or second unsuccessful treatment discontinuation in chronic myeloid leukemia estimating the efficacy of nilotinib in inducing the persistence of molecular remission after stopping tyrosine kinase inhibitors a second or third time (EudraCT no. 2015-004998-33)

Indication and most important inclusion criteria

This study includes patients from 18 years of age with chronic myeloid leukemia (CML) who have had a molecular relapse after a prior first or second attempt to stop therapy with a tyrosine kinase inhibitor (TKI) therapy and who have been treated for at least one year with any TKI after the first stop.

Short description of intervention

Patients will be treated with nilotinib 600 mg/day for at least two years. Patients who achieve deep molecular remission (MR4.5 or better) at the end of treatment can attempt stopping TKI treatment.

The main objective of the study is to assess whether more patients maintain at least major molecular remission at 12 and 36 months after stopping TKI therapy.

Type of study

Treatment discontinuation trial

Current status

recruiting

Study sponsor

University of Heidelberg, Germany, with financial support from Novartis GmbH

Scientific lead / contact

Prof. Dr. Susanne Saußele
Studienzentrale Hämatologie, III. Med. Klinik
Medizinische Fakultät Mannheim der Universität Heidelberg
68169 Mannheim, Germany

Principal investigator

Prof. Dr. Susanne Saußele
Studienzentrale Hämatologie, III. Med. Klinik
Medizinische Fakultät Mannheim der Universität Heidelberg
68169 Mannheim, Germany

Additional information

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

Study centers / principal investigators

Germany

Aachen
Universitätsklinikum der RWTH Aachen
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Prof. Dr. med. Tim Henrik Brümmendorf
Pauwelsstr. 30
52074 Aachen

Ansbach
Ambulantes Onkologie Zentrum
Dr. med. Markus Hahn
Schöneckerstr. 4
91522 Ansbach

Aschaffenburg
Studienzentrum Aschaffenburg
Dr. med. Martine Klausmann
Elisenstr. 26
63739 Aschaffenburg

Bayreuth
Klinikum Bayreuth GmbH
Medizinische Klinik IV
PD Dr. med. Alexander Kiani
Preuschwitzer Str. 101
95445 Bayreuth

Berlin
Charité – Universitätsmedizin Berlin, CVK
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
Professor Dr. med. Philipp le Coutre
Augustenburger Platz 1 (Mittelallee 11)
13353 Berlin

Chemnitz
Klinikum Chemnitz gGmbH
Klinik für innere Medizin III
Dr. med. Mathias Hänel
Flemmingstr. 2
09113 Chemnitz

Dresden
Onkozentrum Dresden
Dr. Göhler/Dörfler/Boldt
DM Steffen Dörfel
Leipziger Str. 118
01127 Dresden

Essen
Universitätsklinikum Essen
Klinik für Hämatologie
Dr. med. Joachim R. Göthert
Hufelandstr. 55
45147 Essen

Esslingen
Onkologische Schwerpunktpraxis
Dr. med. Robert Eckert
Berliner Str. 4
73728 Esslingen

Frankfurt
Centrum für Hämatologie und Onkologie Bethanien
Prof. Dr. med. Hans Tesch
Im Prüfling 17-19
60389 Frankfurt

Freiburg
Universitätsklinikum Freiburg
Innere Medizin I
Prof. Dr. med. Nikolas von Bubnoff
Hugstetter Str. 55
79108 Freiburg

Goslar
MVZ Onkologische Kooperation Harz
Dr. Mark-Oliver Zahn
Kösliner Straße 14
38642 Goslar

Greifswald
Universitätsmedizin Greifswald
Klinik Innere Medizin C / Hämatologie und Onkologie
Prof. Dr. Christian Andreas Schmidt
Ferdinand-Sauerbruchstraße
17475 Greifswald

Halle (Saale)
Universitätsklinikum Halle
Universitätsklinik und Poliklinik für Innere Medizin IV
PD Dr. med. Haifa Kathrin Al-Ali
Ernst-Grube-Str. 40
06120 Halle (Saale)

Hannover
Medizinische Hochschule Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
PD Dr. med. Christian Könecke
Carl-Neuberg-Str. 1
30625 Hannover

Heilbronn
Schwerpunktpraxis Onkologie
Dr. med. Jolanta Dengler
Allee 40
74072 Heilbronn

Jena
Universitätsklinikum Jena, Klinik und Poliklinik für Innere Medizin II
Hämatologie/Onkologie/ Stammzelltransplantation
Prof. Dr. med. Andreas Hochhaus
Erlanger Allee 101
07740 Jena

Kempten
Klinikum Kempten
Hämatologie, Onkologie und Palliativmedizin
PD Dr. med. Christian Langer
Robert-Weixler- Straße 50
87439 Kempten

Köln
Gemeinschaftspraxis für Onkologie und Hämatologie
Prof. S. Schmitz, Dr. Steinmetz, Dr. Severin
Dr. med. Hans Tilman Steinmetz
Sachsenring 69
50677 Köln

Mannheim
Universitätsmedizin Mannheim
III. Med. Klinik Mannheim
Prof. Dr. med. Susanne Saußele
Theodor-Kutzer-Ufer 1-3
68167 Mannheim

Marburg
Universitätsklinikum Gießen und Marburg,
Standort Marburg
Klinik für Hämatologie, Onkologie und Immunologi
Prof. Dr. med. Andreas Burchert
35043 Marburg

München
Klinikum rechts der Isar
Klinik und Poliklinik für innere Medizin III
PD Dr. med. Philipp Jost
Ismaninger Str. 22
81675 München

Mutlangen
Klinikum Ostalb, Stauferklinikum Schwäbisch Gmünd
Zentrum für Innere Medizin
Prof. Dr. Holger Hebart
Wetzgauer Str. 85
73557 Mutlangen

Rostock
Universitätsmedizin Rostock
ZIM III - Hämatologie, Onkologie, Palliativmedizin
Prof. Dr. med. Christian Junghanß
Ernst-Heydemann-Straße 6
18057 Rostock

Villingen Schwenningen
Schwarzwald-Baar Klinikum
Klinik für Innere Medizin II
Prof. Dr. med. Paul Graf La Rosée
Klinikstraße 11
78052 Villingen-Schwenningen


The Netherlands

VU University Medical Center Amsterdam
Dr. Jeroen Janssen
1081 HV Amsterdam

 

 

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

Not yet 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 centers / principal investigators

France

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



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 (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

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 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
Dominik Wolf (National Coordinator)

Essen
Joachim Göthert

Mannheim
Susanne Saußele

Marburg
Anderas Burchert

Villingen-Schwenningen
Paul Graf la Rosée


Norway

Bergen
Haukeland University Hospital
Bjørn Tore Gjertsen

Oslo
Oslo University Hospital
Tobias Gedde Dahl

Stavanger
Stavanger University Hospital
Waleed Majeed (National Coordinator)

Trondheim
St Olavs Hospital-Trondheim University Hospital
Henrik Hjorth Hansen


Sweden

Linköping
Linköping University Hospital
Kourosh Lofti and Arta Dreimane

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

 

PonaZero = Effect of Consolidation Treatment with Ponatinib on TFR Rate [Spain]

Study title

PonaZero = Effect of Consolidation Treatment with Ponatinib on Treatment-free Remission Rate in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) with Deep Molecular Response

Scientific title

Multicenter, open-label, randomized phase III pilot study to evaluate the effect of a one-year consolidation treatment with ponatinib at two-dose ranges on free-remission rate in patients with Philadelphia-positive chronic myeloid leukemia, who had previously achieved a deep molecular response (EudraCT no. 2017-004565-27)

Indication and most important inclusion criteria

This study includes patients who:
- have BCR-ABL positive chronic myeloid leukemia in chronic phase (CP-CML)
- have been on imatinib treatment for a minimum of 4 years with confirmed stable deep molecular response (MR4) for a minimum of 12 months prior to enrolment
- are at least 18 years old
- have not had a prior accelerated phase/blast crisis (AP/BC) or stem cell transplant (SCT)
- have an Eastern Co-Operative Group (ECOG) status of 0-2

Short description of intervention

This is a pilot study to determine the rate of successful treatment-free remission (TFR) in patients who achieved and maintained molecular response 4 (MR4) on ponatinib following at least 4 years of imatinib therapy. Patients who maintain MR4 during the 52-week ponatinib onsolidation phase can attempt stopping ponatinib and will continue in the 104-week TFR phase.

Type of study

7. Treatment discontinuation trials

Current status

Recruiting

Study sponsor

FUNDACIÓN TEÓFILO HERNANDO, Edificio Claid
Parque Científico de Madrid
Calle Faraday, 7, Campus de Cantoblanco, 28049 Madrid

Scientific lead / contact

Gutierrez, Garcia

Principal investigator

Multiple

Additional information

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

Study centers / principal investigators

Spain

Badalona, Barcelona, 08916
Hospital Trials i Pujol
Dr. Blanca Xicoy

Barcelona, 08035
Hospital Vall D'Hebron
Dr. Guillermo Orti

Las Palmas De Gran Canaria, 35010
Hospital Universitario de Gran Canarias Dr. Negrin
Dr. Maria Teresa Gomez

Madrid, 28006
Hospital Unversitario de la Princesa
Juan Luis Steegmann, MD PhD

Madrid, 28034
Hospital Universitario Ramon y Cajal
Valentin Garcia Gutierrez, MD PhD

Madrid, 28041
Hospital Universitario Doce de Octubre
Rosa Ayala, MD PhD

Málaga, 29010
Hospital Regional de Malaga
Dr. Antonio Jimenez

Salamanca, 37007
Hospital Universitario de Salamanca
Fermin Sanchez-Guija, MD PhD

Valencia, 46010
Hospital Clinico Universitario de Valencia
Dr. Juan Carlos Hernandez Boluda



 

QMH-CML-001 = Cessation of TKI in CML [Hong Kong]

Study title

QMH-CML-001 = Cessation of Tyrosine Kinase Inhibitors in Patients With Chronic Phase Chronic Myelogenous Leukaemia

Scientific title

Cessation of Tyrosine Kinase Inhibitors in Patients With Chronic-phase Chronic Myelogenous Leukaemia Who Achieve Stable Deep Molecular Response (ClinicalTrials.gov NCT03131986)

Indication and most important inclusion criteria

This study includes male or female patients who:

- are at least 18 years old
- have been diagnosed with chronic myeloid leukemia in chronic phase
- have been treated with a tyrosine kinase inhibitor (TKI) in first line, or in second line due to intolerance of another first-line TKI
- have been on treatment with the same TKI for at least 3 years and had deep molecular response (MR4.5) for at least 2 years

Short description of intervention

International clinical trials have demonstrated that about 40-60% of CML patients who achieved deep molecular response on TKI manage to remain in sustained treatment-free remission after stopping treatment. Experience of discontinuing TKI treatment is lacking in Hong Kong.

The objective of this single-arm study is to collect local experience with TKI discontinuation in patients with CML in chronic phase who are treated with TKIs and remain in stable deep molecular response for at least two years. Patients who stop TKI treatment will be closely monitored and treatment outcomes will be reassessed.

Type of study

Treatment discontinuation trial

Current status

Recruiting

Study sponsor

The University of Hong Kong

Scientific lead / contact

Professor Yok-lam Kwong
The University of Hong Kong

Principal investigator

Contact: Yuk Man Cheung, MBBS(HK)

Additional information

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

Study centers / principal investigators

Hong Kong

Yuk Man Cheung, MBBS(HK)
Queen Mary Hospital, Hong Kong

 

ENDURE = Efficacy and Safety of AOP2014 With CML Patients in Remission [France, Germany]

Study title

ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission (ENDURE-CML-IX)

Scientific title

Efficacy and safety of pegylated-proline-interferon alpha 2B (AOP2014) in maintaining deep molecular remission in patients with chronic myeloid leukemia (CML) who discontinue ABL-kinase inhibitory therapy - a randomized phase II, multicenter trial with post-study follow-up (EudraCT no. 2016-001030-94,ClinicalTrials.gov NCT03117816)

Indication and most important inclusion criteria

This study includes male or female patients who:

- are at least 18 years old
- have been diagnosed with BCR-ABL-positive, chronic myeloid leukemia in chronic phase
- have been treated with a tyrosine kinase inhibitor (TKI) for at least 3 years
- have had confirmation of deep molecular remission of MR4 or better (MR4.5, MR5) at least three times within the last year before study entry.

Patients who failed to discontinueTKI in a prior discontinuation attempt are eligible for this study. Additional criteria may apply.

Short description of intervention

Previous clinical studies have shown that about half of all CML patients who achieved good response on long-term therapy manage to stop TKI treatment permanently. Unfortunately, it is not possible to predict whether discontinuation will be successful or not.

The objective of this study is to find out whether temporary treatment with ropeginterferon (AOP2014) can activate the immune system to prevent loss of major molecular remission in CML patients, who discontinue TKI treatment in deep molecular remission of MR4 or better (MR4.5, or MR5).

In this study, patients will be randomly assigned to one of two treatment groups:
Patients in Group A will receive ropeginterferon in the first month after enrolment together with the TKI. After this first month, the TKI therapy will be stopped and paitens will receive ropeginterferon for the next14 months. Ropeginterferon is injected with a pre-filled auto-injection pen under the skin every 2 weeks. It is very well tolerated.
Similar as in the Group A, patients in Group B will discontinue TKI therapy one month after randomization. From then on patients will receive no further CML treatment.

Patients will be closely monitored and treatment outcomes will be assessed.

Type of study

Treatment discontinuation trial

Current status

Recruiting

Study sponsor

Philipps University Marburg Medical Center
in collaboration with
Deutsche Krebshilfe e.V., Bonn (Germany)
AOP Orphan Pharmaceuticals AG

Scientific lead / contact

Prof. Dr. med. Andreas Burchert, Marburg

Principal investigator

Multiple

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

Lyon
Centre Léon Bérard
Franck-Emmanuel Nicolini, MD
Lyon, 69008

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

Germany

Aachen
Universitätsklinikum RWTH Aachen
Martina Crysant, MD
527074 Aachen

Aschaffenburg
Martine Klausmann, MD
63739 Aschaffenburg

Berlin
Universitätsmedizin Berlin Charite- Campus Virchow Klinikum
Prof. Philipp Le Coutre
13353 Berlin

Bonn
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III
Dr. Jai-Jün Shiue
53105 Bonn

Bremen
Klinikum Bremen Mitte, Medizinische Klinik I
Dr. Mathhias Bormann
28177 Bremen

Dresden
BAG / Onkologische Gemeinschaftspraxis
PD Dr. Thomas Illmer
01307 Dresden

Düsseldorf
Universitätsklinikum Düsseldorf
Prof. Norbert Gattermann
40225 Düsseldorf

Erlangen
Universitätsklinikum Erlangen
Prof. Stefan Krause
91054 Erlangen

Essen
Universitätsklinikum Essen, Klinik für Hämatologie
Dr. Joachim Goethert
45147 Essen

Frankfurt
Klinikum der Goethe Universität, Medizinische Klinik II
Dr. Fabian Lang
60590 Frankfurt

Hamburg
Universitätsklinikum Hamburg Eppendorf
Dr. Philippe Schafhausen
20246 Hamburg

Hamm
Evangelisches Krankenhaus Hamm gGmbH
Dr. Elisabeth Lange
59063 Hamm

Jena
Universitätsklinikum Jena
Prof. Andreas Hochhaus
07747 Jena

Koblenz
Institut für Versorgungsforschung in der Onkologie GbR
Dr. Christoph Lutz
56068 Koblenz

Leipzig
Universitätsklinikum Leipzig
Dr. Georg-Nikolaus Franke
04103 Leipzig

Mainz
Johannes-Gutenberg-Universität
III. Medizinische Klinik
PD Dr. Thomas Kindler
55131 Mainz

Mannheim
Universitätsmedizin Mannheim
Prof. Susanne Saußele
68169 Mannheim

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

München
III. Medizinische Klinik TUM
Klinikum rechts der Isar
PD Dr. Philipp Jost
81675 München

Münster
Universitätsklinikum Münster
Dr. Eva Schmidt
48149 Münster

Tübingen
Med. Univ.-Klinik II
Prof. Robert Möhle
72076 Tübingen

Ulm
Universitätsklinikum Ulm
PD Dr. Frank Stegelmann
89081 Ulm

Würzburg
Zentrum für Innere Medizin
Dr. Maria-Elisabeth Goebler
97080 Würzburg

 

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