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

Study title

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

Scientific title

Multicenter prospective trial after first 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 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 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 make a second attempt to stop 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
III. Med. Klinik
Medizinische Fakultät Mannheim der Universität Heidelberg
68169 Mannheim, Germany

Principal investigator

Prof. Dr. Susanne Saußele
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

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

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

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 Munich

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

 

 

ENESTPath Patient's Voice Italian Substudy [Italy]

ENESTPath Patient's Voice Italian Substudy [Italy]

ENESTPath Patient's Voice Italian Substudy

Scientific title

CML patient's voice: A pilot sub-study exploring the emotional experience of patients during CAMN107AIC05 Study - Italian substudy of ENESTPath (clinicaltrials.gov NCT01743989, EudraCT 2012-005124-15)

Indication and most important inclusion criteria

Patients in consolidation study phase of ENESTPath who will perform visit 6 at the time of sub-study activation

Short description of intervention

Patients from Italian centres participating in ENESTPath will undergo specific Quality of Life and psychological assessments during the consolidation and treatment-free remission phase.

The following tools will be used:

  • Patient Diary
  • EORTC QLQW-C30: a questionnaire to assess the quality of life of cancer patients
  • EORTC-CML: a questionnaire to assess the quality of life of CML patients
  • Sixteen Personality Factor Questionnaire (16PF): a self-report personality test;
  • Symptom Checklist 90 (SCL.90-R): a self reported questionnaire

Type of study

5. Treatment discontinuation trials
In a single country

Current status

Starting to obtain Ethics Committee approvals

Study sponsor

Novartis

Scientific lead / contact

Claudia Galimberti Novartis Farma S.p.A.

Principal investigator

Luca Dezzani Novartis Farma S.p.A.

Additional information

...

Study centers / principal investigators

Italian centers participating in ENESTPath

 

 

 

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

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

Additional information

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

Study centers / principal investigators

Spain

up to 11 sites

 

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

 

Please donate!

Please donate!

LogIn

EU e-Privacy Directive