CA180-226 = Dasatinib Powder for Oral Suspension Substudy [Mexico, Romania, Spain, USA]

Study title

CA180-226 = Dasatinib Powder for Oral Suspension PK Substudy

Scientific title

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib (ClinicalTrials.gov no NCT00777036)

Indication and most important inclusion criteria

Children up to 18 years old who have chronic phase chronic myeloid leukemia (CP CML) and are taking daily dasatinib (tablets or powder for oral suspension)

Short description of intervention

This is a pharmacokinetic (PK) substudy to evaluate how dasatinib powder formulation in oral solution and dasatinib powder for oral suspension are absorbed, distributed, metabolized in the body and excreted from the body.

Type of study

Pediatric trials

Current status

Active, not recruiting

Study sponsor

Bristol-Myers Squibb

Scientific lead / contact

Mariana Sacchi
mariana.sacchi@bms.com

Principal investigator

Multiple

Additional information

Study centers / principal investigators

Mexico
Mexico City
Instituto Nacional De Pediatria

Romania
Bucharest
Institutul Clinic Fundeni

Spain
Madrid
Hospital Universitario Nino Jesus

USA
Boston
Dana Farber Cancer Institute

Chicago
Children's Hospital of Chicago

Houston
Texas Children'S Cancer Center

 

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


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

Recruitment status unknown

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

 

 

PF-114 Dose-finding Study in Ph+ CML Patients Resistant to 2nd Generation TKI or Presenting T315I Mutation [Russia]

Study title

Dose-finding Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 in Adult Ph+ CML Patients Resistant to 2nd Generation TKI or Presenting T315I Mutation  [Russia]

Scientific title

A Multicenter, Open Label Cohort Phase 1 Dose Finding Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of PF-114 Mesylate for Oral Administration in Adult Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML), Which is Resistant to the 2-nd Generation Bcr-Abl Inhibitors or Has T315I Mutation in the BCR-ABL Gene
(Clinicaltrials.gov No. NCT02885766)

Indication and most important inclusion criteria

Male or female patients 18 years of age or older with Ph+ CML in chronic phase (CP) or accelerated phase (AP) according to European LeukemiaNet guidelines (2013) can be considered for inclusion if they are intolerant to approved Bcr-Abl inhibitors or have not responded to previous treatment with at least one 2nd generation inhibitor of Bcr-Abl (dasatinib or nilotinib or bosutinib) or if they present T315I mutation in the BCR-ABL gene. In case of previous history of blast crisis phase of CML at least 6 months must have passed after the end of blast crisis phase and intake of the first dose of PF-114. To be included, patients need to have an ECOG performance status below or equal to 2 and adequate kidney, liver and heart function.

Short description of intervention

In this dose-finding study, PF-114 will be given by mouth, starting with a dose of 50 mg once daily in the first patient group. In the next patient groups, the dose is gradually increased up to 400 mg/day. The dose can be increased further based on the assessment of the safety findings by the investigators and the sponsor. 

Type of study

Trial after therapy failure or intolerance

Current status

No longer recruiting. Interim results available.

Study sponsor

Fusion Pharma LLC

Scientific lead / contact

Veronika Shulgina MD, PhD
+7 916 815 05 44
veronika.shulgina@fusion-pharma.com

Principal investigator

1. Prof. DMSci Anna Turkina
2. Elza Lomaia MD, PhD

Additional information

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

Study centers / principal investigators

Moscow
National Research Center for Hematology
Russia, 125 167, Moscow, Novii Zikovskii pr., 4

Principal Investigator:
Prof. DMSci Anna Turkina — Head of Myeloproliferative diseases
Clinical Study Coordinator:
Oleg Shuhov MD, PhD
shuhov@list.ru
+7 985 287 12 69


Moscow
Moscow City Centre of Hematology based on City Hospital named by S.Botkin
5, 2-nd Botkin's lane, build. 17, entrance 3
125284 Moscow

Principal Investigator:
Prof. DMSci Olga Vinogradova — Head of Moscow City Centre of Hematology
olgavinz@mail.ru
tel. +7(495)945-97-61


St. Petersburg
Federal Almazov North-West Medical Research Centre
Russia, 197 341, St. Petersburg, Akkuratova st., 2

Principal Investigator:
Elza Lomaia MD, PhD, — lead scientist of Onco-hematology Department
lomelza@gmail.com
+7 981 936 16 67

OPTIC 2L = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]

Study title

OPTIC-2L = A Study Comparing Ponatinib and Nilotinib in Patients With Chronic Myeloid Leukemia

Scientific title

A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib (AP24534-15-303) (EudraCT2015-001318-92, NCT02627677)

Indication and most important inclusion criteria

This study includes patients who:
- have chronic myeloid leukemia in chronic phase (CP-CML) and are resistant to first-line imatinib treatment
- are at least 18 years old, have an Eastern Co-Operative Group (ECOG) status of 0-1, have given written informed consent and comply with scheduled visits and study procedures
- have adequate kidney and liver function as well as normal pancreatic status
- have a negative pregnancy test, use a highly effective form of contraception from randomization through at least 4 months after the end of treatment (for female and male patients who are fertile)
- have fully recovered from the acute effects of prior cancer therapy (hydroxyurea or imatinib) before initiation of study drug

Additional criteria apply.

Short description of intervention

This is a study to demonstrate the efficacy and safety of 2 starting doses of ponatinib (30 and 15 mg once daily) as a treatment for CP-CML compared to nilotinib (400 mg twice daily), as measured by major molecular response (MMR) by 12 months.

Type of study

Second line trial after treatment failure

Current status

Active, not recruiting

Study sponsor

Takeda (Previously Ariad Pharmaceuticals)

Scientific lead / contact

Heinrich Farin, MD; Heinrich.Farin@ARIAD.com

Principal investigator

Dr. Violaine Havelange, Cliniques Universitaire Saint-Luc (Site 058), Bruxelles, Belgium, 1200

Additional information

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

Study centers / principal investigators

The study is being performed in the following countries:

Argentina, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Korea, Netherlands, Poland, Portugal, Romania, Russia, Singapore, Spain, Switzerland, UK

 

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