CABL001X2101 = A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With CML or Ph+ ALL [Asia, Australia, Europe]

Study title

CABL001X2101 = A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With CML or Ph+ ALL [Asia, Australia, Europe]

Scientific title

A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL) (EudraCT 2013-004491-36, ClinicalTrials.gov NCT02081378)

Indication and most important inclusion criteria

Patients 18 years and older with Philadelphia chromosome-positive CML in chronic or accelerated phase who were previously treated with two different tyrosine kinase inhibitors (TKIs) and are relapsed, resistant to or intolerant of TKIs.
Adult patients with cytopathologically confirmed Ph+ ALL who are relapsed or resistant to one prior TKI or intolerant of TKIs.
TKI failure for Ph+ ALL patients is defined as at least the loss of Molecular Response (MR) 4.5 (BCR-ABL ≤ 0.0032%).

Short description of intervention

This first-in-human, open label, dose finding study is conducted to establish a safe and tolerated dose of ABL001 in CML and Ph+ ALL patients who are relapsed or resistant to or are intolerant of TKIs. In these patients, ABL001 may provide a novel therapeutic option.
ABL001 capsules will be administered orally in a dose escalation schedule.

Type of study

Trial after therapy failure or intolerance

Current status

recruiting

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

For Germanny:
Prof. Dr. Oliver Ottmann
Universitätsklinikum Frankfurt

Additional information

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

Study centers / principal investigators

Australia, South Australia
Adelaide, 5000
Novartis Investigative Site

France
Bordeaux, 33076
Novartis Investigative Site

Paris, Cedex 10, 75475
Novartis Investigative Site

Germany
Charité
13353 Berlin

Universitätsklinikum Frankfurt
60590 Frankfurt

Universitätsklinikum Jena
Klinik für Innere Medizin II. Abteilung Hämatologie und Internistische Onkologie
07743 Jena

Italy
Roma, 00161
Novartis Investigative Site

Japan
Kobe-city, Hyogo, 650-0017
Novartis Investigative Site

Korea, Republic of
Seoul, 137-701
Novartis Investigative Site

Netherlands
Amsterdam, 1081 HV
Novartis Investigative Site

Singapore
Singapore, 28006
Novartis Investigative Site

Spain
Madrid, 28006
Novartis Investigative Site

USA
Massachusetts
Dana Farber Cancer Institute
Hematology / Oncology
Boston, 02215

Michigan
University of Michigan Comprehensive Cancer Center SC
Ann Arbor, 48109-0944

New York
Memorial Sloan Kettering Cancer Center
New York, 10065

Oregon
Oregon Health & Science University SC-6
Portland, 97239

Texas
University of Texas
MD Anderson Cancer Center
Houston, 77030-4009

Utah
University of Utah
Huntsman Cancer Institute
Salt Lake City, 84112

 

ASCEMBL (CABL001A2301) = ABL001 versus bosutinib in CML-CP patients pretreated with ≥2 TKI [Asia, Australia, Europe, North America, South America]

Study title

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BEST - Bosutinib in Elderly Chronic Myeloid Leukemia [Italy]

Study title

Bosutinib in Elderly Chronic Myeloid Leukemia (BEST)

Scientific title

Bosutinib Efficacy, Safety, Tolerability (BEST) Study in Elderly Chronic Myeloid Leukemia Patients Failing Front-line Treatment With Other Tyrosine Kinase Inhibitors (ClinicalTrials.gov NCT02810990)

Indication and most important inclusion criteria

Male or female patients 60 years of age or older with a molecular confirmed diagnosis of BCR-ABL1+ CML in chronic phase and prior first-line treatment with any other tyrosine kinase inhibitor.
Patients can be considered for inclusion in the study if they are intolerant to prior treatment, based on investigator and patient assessment, or have not responded to prior treatment (assessed according to any one of the ELN 2013 criteria).

Short description of intervention

The purpose of this study is to evaluate the tyrosine kinase inhibitor (TKI) bosutinib in elderly patients who did not obtain any benefit with other drugs before.

The median age of newly diagnosed CML patients is about 56 years, and at least 40% of all newly diagnosed patients are over 60 years old. Particularly for these elderly patients, the choice of TKI must take into account the safety and tolerability profile of the drug. This study tests the efficacy, safety and tolerability of bosutinib in second-line treatment, beginning with a low dose (200 mg once daily) and adjusting subsequent doses (up to 400 mg once daily) based on molecular response and on adverse events.

Type of study

Trial after therapy failure or intolerance

Current status

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

Study centers / principal investigators

Italy

Ancona
S. Rupoli

Bari
G. Specchia

Bologna
S. Orsola-Malpighi University Hospital
G. Rosti

Cagliari
"A. Businco"
E. Usala

Catania
F. Stagno

Cuneo
D. Rapezzi

Ferrara
F. Cavazzini

Genova
IRCCS San Martino
M. Gobbi

Meldola
IRST
A. Lucchesi

Messina
Policlinico G. Martino
C. Musolino

Milano
Ist. Nazionale Tumori
F. Spina

Milano
Osp. Maggiore Policlinico
A.Iurlo

Milano
Ospedale San Raffaele
F. Ciceri

Napoli
Univ. Studi Napoli "Federico II"
F. Pane

Novara
M. Lunghi

Orbassano
C. Rege Cambrin

Parma
M. Crugnola

Piacenza
D. Vallisa

Ravenna
M. Salvucci

Reggio Emilia
I. Capodanno

Rimini
A. L. Molinari

Roma
Gemelli
F. Sorà

Roma
Ospedale Sant'Eugenio
E. Abruzzese

Roma
San Giovanni Addolorata
M. Cedrone

Roma
S.Camillo Forlanini Hospital
Dr. S.Mancini

San Giovanni Rotondo
N. Cascavilla

Siena
M. Bocchia

Torino
Città della salute e della scienza
D. Ferrero

Verona
M. Bonifacio

 

 

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

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

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

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


PONS = Ponatinib in Second Line [Germany]

Study title

PONS Study = Ponatinib for Treatment of Patients with CP-CML after Treatment with Other TKI has Failed

Scientific title

PONS Phase 2 Clinical Trial with Ponatinib 30mg as a Second Line Therapy for Patients with Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to First Line Tyrosine Kinase Inhibitor Treatment
(EudraCT number: 2016-000618-30 / ClinicalTrials.gov no NCT03807479)

Indication and most important inclusion criteria

Adult patients (age ≥ 18) diagnosed with Ph-positive (by cytogenetics) or BCR-ABL-positive (by PCR) chronic myeloid leukemia (CML) in chronic phase.

Patients should have demonstrated to have
- a failure of a prior first line TKI treatment with either imatinib, dasatinib or nilotinib, defined as per European LeukemiaNet (ELN) recommendations,
- or intolerance to prior TKI treatment defined as grade 3 or 4 toxicity, or persistent grade 2 toxicity despite optimal management including dose adjustment, or in a patient where dose reductions are considered to be not in the patient's best interest to obtain an adequate response. Intolerant patients should not have achieved or have lost major cytogenetic molecular response at the time of enrollment.

Patients should also have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, as well as adequate function of liver, kidney and pancreas. Patients should have fully recovered from the acute effects of prior cancer therapy.

Pregnant patients cannot be included.

Additional criteria may apply.

Short description of intervention

This is a non-randomized, open label study evaluating the safety and efficacy of second line ponatinib therapy in patients suffering from Chronic Myeloid Leukemia in Chronic Phase and who are resistant or intolerant to earlier treatment with another Tyrosine Kinase Inhibitor (TKI). Ponatinib will be given at a dose of 30mg. The dose may be reduced further to 15mg. The study is being performed in Germany.

Type of study

2. Second line trials after therapy failure

Current status

Recruiting

Study sponsor

GWT-TUD GmbH
Incyte Biosciences International Sàrl

Scientific lead / contact

J. Bernds
GWT-TUD GmbH

Principal investigator

Prof. Dr. med. Philipp le Coutre
Charité - Universitätsmedizin Berlin
Department of Hematology, Oncology and Tumor Immunology
10117 Berlin, 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 RWTH Aachen
Medizinische Klinik IV
Dr. med. Martina Crysandt

Berlin
Charité - Universitätsmedizin Berlin
Campus Virchow Klinikum
Prof. Dr. med. Philipp le Coutre

Essen
Universitätsklinikum Essen gGmbH
Dr. med. Joachim Göthert

Marburg
Universitätsklinikum Gießen und Marburg GmbH
Prof. Dr. med. Andreas Burchert

Greifswald
Universitätsmedizin Greifswald
Prof. Dr. med. Christian Andreas Schmidt

Mannheim
III. Med. Klinik
Medizinische Fakultät Mannheim der Universität Heidelberg
Prof. Dr. med. Susanne Saußele

 

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