OPUS = Optimizing Ponatinib Use [Italy]

Study title

Optimizing Ponatinib Use (OPUS)

Scientific title

A GIMEMA Phase 2 Study of the Activity and Risk Profile of Ponatinib, 30 mg Once Daily, in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) Patients Resistant to Imatinib (EudraCT no. 2015-001102-34, ClinicalTrials.gov NCT02398825)

Indication and most important inclusion criteria

Male or female patients 18 years of age or older with a cytogenetic or molecular confirmed diagnosis of BCR-ABL1+ CML in chronic phase.
Patients can be considered for inclusion in the study if they have been treated with imatinib at any dose but not responded to treatment (as assessed according to any one of the ELN 2013 criteria).

Short description of intervention

The purpose of this study is to evaluate ponatinib in patients with chronic myeloid leukemia in chronic phase who were previously treated with imatinib but shown resistance to it.

Patients will be given ponatinib 30 mg daily by mouth. Once a BCR-ABL1 level smaller or equal to 0.1% (MMR) has been achieved and confirmed by a second test after 4 weeks, the dose will be reduced to 15 mg daily. If BCR-ABL1 levels return to above 1%, the ponatinib dose will be increased again to 30 mg. The dose will be adjusted if adverse events occur. Each patient will be treated in the study for 52 weeks.

Type of study

Trial after therapy failure or intolerance

Current status

No longer recruiting

Study sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Scientific lead / contact

Prof. Gianantonio Rosti
Department of Oncology and Hematology
O.U. of Hematology
S. Orsola-Malpighi University Hospital
Bologna, Italy

Principal investigator

Prof. Gianantonio Rosti
Department of Oncology and Hematology
O.U. of Hematology
S. Orsola-Malpighi University Hospital
Bologna, Italy

Additional information

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

Study centers / principal investigators

Italy

Alessandria
V. Giai

Bologna
S. Orsola-Malpighi University Hospital
G. Rosti

Brescia
Spedali Civili - Azienda Ospedaliera
G. Rossi

Cagliari
Businco
E. Usala

Catania
Ospedale "Ferrarotto"
F. Di Raimondo

Catanzaro
Molica

Cuneo
D. Rapezzi

Ferrara
A. Cuneo

Genova
IRCCS
Prof. M.Gobbi

Lecce
N. Di Renzo

Meldola
A. Lucchesi

Messina
Policlinico G. Martino
C. Musolino

Milano
IRCCS Ospedale
A. Iurlo

Milano
Ist. Nazionale Tumori
F. Spina

Milano
San Raffaele
F. Ciceri

Napoli
Cardarelli
M. Annunziata

Napoli
Univ. Studi Napoli – Federico II
F. Pane

Orbassano
C. Rege Cambrin

Palermo
Ospedali Riuniti "Villa Sofia-Cervello"
F. Fabbiano

Palermo
Policlinico "Paolo Giaccone"
V. Accurso

Pavia
E. M. Orlandi

Pescara
P. Di Bartolomeo

Piacenza
Ospedale G. da Saliceto
D. Vallisa

Pisa
S. Galimberti

Ravenna
M. Salvucci

Rimini
A. L. Molinari

Roma
Ospedale Sant'Eugenio
E. Abruzzese

Roma
S.Camillo Forlanini Hospital
Dr. S.Mancini

San Giovanni Rotondo
N. Cascavilla

Siena
M. Bocchia

Terni
A. M. Liberati

Treviso
F. Gherlinzoni

Verona
M. Bonifacio

Vicenza
E. Di Bona

Matchpoint - Ponatinib and Intensive Chemotherapy [UK]

Study title

Matchpoint - Ponatinib and Intensive Chemotherapy

Scientific title

Management of Transformed Chronic myeloid leukaemia: Ponatinib and intensive chemotherapy: a dose finding study (Clinicaltrialsregister.eu 2012-005629-65)

Indication and most important inclusion criteria

Male or female patients of 16 years of age or older with Ph-positive or BCR-ABL positive chronic myeloid leukemia (CML) in blast phase (BP).
Patients can be considered for inclusion in the study if they are suitable for intensive chemotherapy, have adequate kidney and liver function as well as normal pancreas function.

Short description of intervention

The aim of this trial is to find a safe and effective dose of a drug called ponatinib when used in combination with chemotherapy in patients with Chronic Myeloid Leukaemia (CML) whose disease has moved in to blast phase.

Type of study

Treatment of advanced phases

Current status

No longer recruiting

Study sponsor

University of Birmingham

Scientific lead / contact

Professor Mhairi Copland
University of Glasgow
Gartnavel General Hospital
Glasgow G12 0ZD

Principal investigator

Prof. Mhairi Copland
University of Glasgow
Gartnavel General Hospital
Glasgow G12 0ZD

Additional information

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

Study description on the website of Cancer Research UK

Study centers / principal investigators

United Kingdom

University of Birmingham
CRCTU, Institute of Cancer and Genomic Sciences
Edgbaston, B15 2TH

Glasgow

Leeds

Liverpool

London

Nottingham

OMNI = Registry to evaluate vascular occlusive events with Iclusig [US]

Study title

An Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With Iclusig® (OMNI)

Scientific title

A Postmarketing Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With Iclusig® (Ponatinib) in Routine Clinical Practice in the US (OMNI) (ClinicalTrials.gov NCT02455024)

Indication and most important inclusion criteria

Adult patients with chronic myeloid leukemia in chronic phase (CP-CML), chronic myeloid leukemia in accelerated phase (AP-CML), chronic myeloid leukemia in blast phase (BP-CML), or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) for whom the decision to initiate treatment with commercially available Iclusig has already been made
 

Inclusion Criteria:

1. Adult patients (age ≥18 years) who are diagnosed with CP-CML, AP-CML, BP-CML, or Ph+ ALL.

2. Patients who are initiating Iclusig therapy for the first time, or for whom Iclusig therapy was initiated within 30 days before registry enrollment.

3. The decision to prescribe Iclusig must have been made prior to enrollment in the registry and based upon approved US indications.

4. Patients who have the ability to understand the requirements of the registry, and provide verbal informed consent to comply with the registry data collection procedures.

Short description of intervention

Additional information is needed to characterize the safety profile of Iclusig as it is used in routine clinical practice in the US. This registry study will collect information about patient demographics, leukemia diagnosis, previous anti-cancer treatments, history of cardiovascular disease, risk factors for vascular complications, and concurrent medications (including antiplatelet and/or anticoagulant agents). 

Type of study

Other trials

Current status

Recruitment was stopped due to insufficient enrollment (business decision)

Study sponsor

Takeda (previously Ariad Pharmaceuticals)
Collaborator: United BioSource Corporation

Scientific lead / contact

Blythe Thomson, MD
Blythe.Thomson@ariad.com

Principal investigator

For OMNI, 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

EU PAS register

Study centers / principal investigators

United States

New Jersey
Hackensack, 07601
John Theurer Cancer Center at Hackensack UMC (Site 128)
Stefan Faderl, MD

New York
Hawthorne, 10532
Hudson Valley Hematology Oncology Associates (Site 236)
Karen Seiter, MD

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

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