PONDEROSA [Czechia, Germany]

Study title

PONDEROSA = Observational study with ponatinib

Scientific title

Observational study on CML patients in any phase treated with ponatinib (Iclusig®) at any dose

Indication and most important inclusion criteria

The study includes patients aged 18 years and older with chronic myeloid leukemia (CML) in any phase on treatment with ponatinib at any dose. Eligible for inclusion are patients who fulfill all inclusion criteria and have given their written consent to participate in the observational study.

Short description of intervention

Further data is needed to characterize the safety profile of ponatinib in routine clinical use in Europe. This observational study will render a realistic picture of the routine clinical use of ponatinib. It will also provide further information on the number and type of adverse events including their outcome in CML patients in any phase treated with ponatinib.

Type of study

Other trial

Current status

recruiting

Study sponsor

Friedrich-Schiller-Universität Jena, Germany, with financial support from Incyte Inc.

Scientific lead / contact

Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
07747 Jena
Germany

Principal investigator

Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
07747 Jena
Germany

Additional information

Study summary by Universitätsklinikum Jena in German

Study centers / principal investigators

Czechia

University Hospital Brno
Brno

University Hospital Hradec Králové
Hradec Králové

University Hospital Olomouc
Olomouc

University Hospital Plzen
Plzen

Institute of Hematology and Blood Transfusion Praha
Praha

University Hospital Vinohrady
Praha

 

Germany

Uniklinik der RWTH Aachen
Aachen

Studienzentrum Aschaffenburg
Aschaffenburg

Klinikum Augsburg
Augsburg

Charité - Universitätsmedizin Berlin, Campus Virchow - Klinikum
Berlin

Internistische FA-Praxis Prof. Josting
Berlin

Praxis Dr. Heßling
Berlin

Onkologische Praxis An der Wertach
Bobingen

St. Vincenz-Krankenhaus
Datteln

Gemeinschaftspraxis Mohm / Prange-Krex
Dresden

Universitätsklinikum Essen
Essen

Onkologische Schwerpunktpraxis
Esslingen

Centrum für Hämatologie und Onkologie Bethanien
Frankfurt/M

Klinikum Goch
Goch

MVZ Onkologische Kooperation Harz
Goslar

Universitätsklinikum Greifswald
Greifswald

OncoResearch Lerchenfeld GmbH
Hamburg

Universitätsklinikum Halle
Halle

OncoCare GbR Halver
Halver

St. Ansgar Krankenhaus Höxter
Höxter

Universitätsklinikum Jena
Jena

Praxis Dr. Steinmetz
Köln

Universitätsklinikum Leipzig
Leipzig

Gemeinschaftspraxis Dres. Müller, Kröning, Jentsch-Ullrich und Tietze
Magdeburg

Universitätsmedizin Mannheim
Mannheim

Rotkreuzklinikum München
München

Schick Hämatologisch-Onkologische Praxisgemeinschaft
München

Hämatologisch-onkologische Schwerpunktpraxis
Neustadt a. Rbge.

Klinikum Passau
II. Medizinische Klinik
Passau

Onkologische SPP Porta Westfalica
Porta Westfalica

Onkologiezentrum Soest
MVZ Kloster Paradiese
Soest

Onkologische Praxis und Tagesklinik Stuttgart
Stuttgart

Klinikum Traunstein
Traunstein

Universitätsklinikum Ulm
Ulm

Klinikum der Stadt Villingen-Schwenningen
Villingen-Schwenningen

Gemeinschaftspraxis für Hämatologie und Onkologie Dr. med. Reichert
Westerstede

MVZ des Marien-Hospital Witten
Witten

Gemeinschaftspraxis Dres. Bock
Wittenberge

Cancer Center Zweiseenland GbR Wolfratshausen
Wolfratshausen

Schwerpunktpraxis Würzburg
Würzburg

MVZ Polikinik West Zwickau
Zwickau

 

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

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

CALLS = CML and ALL Low Level Mutation Study in the UK [UK]

Study title

CALLS Study = CML and ALL Low Level Mutation Study

Scientific title

A Cohort Study To Establish the Prevalence of Mutations in Patients with CML Who Meet the ELN Criteria for Warning or Failure and Patients With Ph+ALL With Detectable BCR-ABL1 Currently Being Treated With First or Subsequent TKI Therapy in the UK Using Next Generation Sequencing. (ClinicalTrials.gov no NCT03647215)

Indication and most important inclusion criteria

Adult patients (age ≥ 18 years) with CML (in all phases of disease) or Ph+ ALL with detectable BCR-ABL levels who are being treated with a first or subsequent tyrosin kinase inhibitor (TKI).

Patients with CML must meet the warning or failure criteria as per the ELN guidelines for first second and subsequent treatment line, including:

BCR-ABL/ABL IS transcripts > 10% at 3 months
BCR-ABL/ABL IS transcripts > 1% at 6 months
BCR-ABL/ABL IS transcripts > 0.1% at 12 months or later OR
Ph+ve ALL patients with any level of BCR-ABL/ABL IS transcripts who are not eligible for UKALL 14 or are not currently enrolled in UKALL 14

Short description of intervention

This is an observational study to establish the prevalence of mutations in patients with CML who meet the ELN criteria for warning or failure and patients with Ph+ ALL with detectable BCR-ABL currently being treated with first or subsequent TKI therapy in the UK.

Type of study

Other trials

Current status

Recruiting

Study sponsor

Incyte Biosciences UK

Scientific lead / contact

Study Director: Michael Thompson, MD Incyte Biosciences UK

Principal investigator

Hugues de Lavallade

Additional information

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

Study description on the NHS website

Study centers / principal investigators

Ireland

University Hospital Waterford
Waterford, X91 ER8E

UK

Royal Cornwall Hospital
Truro, Cornwall, TR1 3LQ

Royal Devon & Exeter Hospital
Exeter, Devon, EX2 5DW

Broomfield Hospital Chelmsford
Chelmsford, Essex, CM1 7ET

Derriford Hospital
Plymouth, Devon, PL6 8DH

Queen's Hospital
Romford, Essex, RM7 0AG

Aberdeen Royal Infirmary
Aberdeen, Foresterhill, AB25 2ZN

Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY

Medway Maritime Hospital
Gillingham, Kent, ME75NY

Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR

Royal Oldham Hospital
Manchester, Lancashire, OL1 2JH

Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH

Ipswich Hospital
Ipswich, Suffolk, IP4 5PD

Heart of England NHS Foundation Trust
Birmingham, West Midlands, B9 5SS

Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ

King's College Hospital
London, SE5 9R

Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ

St James's University Hospital
Leeds, West Yorkshire, LS9 7TF

Monklands Hospital
Airdrie, ML6 0JS

Bristol Haematology and Oncology Centre
Bristol, BS2 8ED

Addenbrooke's Hospital
Cambridge, CB2 0QQ

University Hospital Wales
Cardiff, CF14 4XW

Croydon University Hospital, Croydon Health Services NHS Trust
Croydon, CR7 7YE

Western General Hospital
Edinburgh, EH4 2XU

Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN

Guy's Hospital
London, SE1 9RT

King's College Hospital
London, SE5 9RS

The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW

Oxford University Hospitals NHS Foundation Trust
Oxford, OX4 2PG

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS FT
Sheffield, S10 2JF

Royal Stoke University Hospital, Cancer Centre, University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, ST4 6QG

Singleton Hospital
Swansea, SA2 8QA

TOPASE - Therapeutic Observatory of Ponatinib About Safety and Efficacy [France]

Study title

TOPASE - Therapeutic Observatory of Ponatinib About Safety and Efficacy

Scientific title

Observational study on CML patients in any phase of the disease, treated with ponatinib (Iclusig®)

Indication and most important inclusion criteria

This study includes patients who:
- are aged ≥18 years and agree to participate in the study
- are presenting CML in any phase
- have been receiving treatment with ponatinib for less than six months
- have the ability to understand the requirements of the study and to comply with the study data collection procedures

Short description of intervention

This is a non-interventional study. Ponatinib will be prescribed in the usual manner in accordance with the terms of the marketing authorization. All treatment decisions are made at the discretion of the patient’s healthcare provider (HCP) as per indication and are not mandated by the study design or protocol.

The study aims at better qualifying the benefit-risk balance of ponatinib in real life and in relation with the treatment history of CML patients therapeutic history.

The patient's health status will be evaluated during a 24-month follow-up. Time points for patient evaluation will be at the discretion of the investigator. It is anticipated that these will occur approximately every 3 months the first year, and then every 6 months.

• Effectiveness will be assessed on the basis of hematologic, cytogenetic and molecular response rates and survival duration (overall and progression-free) according to the center practices.
• Tolerance will be assessed by the collection of adverse events.

Type of study

Other trial

Current status

recruiting

Study sponsor

INCYTE BioSciences France

Scientific lead / contact

Prof. Ali Turhan

Principal investigator

Prof. Ali Turhan
Paris Sud University Hospitals-Bicetre & Paul Brousse
Research Director, Inserm U935 & INGESTEM Pluripotent Stem Cell Infrastructure
78 Rue du Général Leclerc, 94275 Le Kremlin Bicêtre, France 

Additional information

 

Study centers / principal investigators

France

Paris Sud University Hospitals
Prof. Ali Turhan

 

 

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