SUSTRENIM = Sustained Treatment-free Remission in Chronic Myeloid Leukemia [Belgium, Italy, Netherlands]

Study title

Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia (SUSTRENIM)

Scientific title

Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia: a Prospective Study Comparing Nilotinib Versus Imatinib With Switch to Nilotinib in Absence of Optimal Response. SUSTRENIM Study - GIMEMA CLM1415 (ClinicalTrials.gov NCT02602314)

Indication and most important inclusion criteria

This study includes patients who:
- have BCR-ABL1+ chronic myeloid leukemia in chronic phase (CP-CML)
- are at least 18 years old
- have an Eastern Co-Operative Group (ECOG) status of 0-2
- have adequate liver and kidney function
- have not been treated before with a BCR-Abl inhibitor for longer than 1 month or with another anticancer agent for CML for longer than 3 months.

Short description of intervention

The purpose of this study is to evaluate nilotinib compared to imatinib followed by a switch to nilotinib in newly diagnosed patients with chronic myeloid leukemia in chronic phase who do not respond optimally according to the definition by the European Leukemia Network (ELN).

Patients will receive either first-line nilotinib 300 mg twice daily by mouth or first-line imatinib 400 mg once daily by mouth. Patients intolerant to imatinib and patients without optimal response to imatinib at 3 months, at 6 months, at 12 months will be switched to nilotinib in second line. Patients with progression to accelerated or blast phase will not be switched.

Patients who achieve deep molecular remission (MR4.5) after the first two years and maintain at least MR4.0 in the first three years of the study and maintain this level in all further tests up to the end of the fourth year of therapy may qualify for treatment discontinuation and enter the treatment free remission (TFR) phase of the study. Patients who are not eligible to discontinue treatment will continue the assigned treatment.

Type of study

First line trial

Current status

No longer recruiting

Study sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) and stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)

Scientific lead / contact

Prof. Fabrizio Pane
Università Federico II of Naples
Italy

Principal investigator

Prof. Fabrizio Pane
Università Federico II of Naples
Italy

Additional information

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

Study description and study flowchart on the website of the Dutch foundation stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)

Study centers / principal investigators

Belgium

Antwerpen
ZNA
Prof. Dr. P. Zachée

Brussels
Cliniques Unversitaris Sain Iuc
Prof. Fr. Havelange

Leuven
UZ Leuven
Prof. G. Verhoef

Haint-Saint-Paul
CH Jolimont
Dr. Kentos


Italy

Alessandria
S.O.C. di Ematologia
Azienda Ospedaliera
SS. Antonio e Biagio e Cesare Arrigo
Massimo Pini

Ancona
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I –
G.M. Lancisi - G. Salesi
Serena Rupoli

Ascoli
U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
Piero Galieni

Asti
S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti
Monia Marchetti

Avellino
Az.Ospedaliera S.G.Moscati
Fausto Palmieri

Bari
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Giorgina Specchia

Barletta
UOC Ematologia Ospedale
"Monsignor Raffaele Dimiccoli"
Giuseppe Tarantini

Bergamo
Azienda Ospedaliera - Papa Giovanni XXIII
Alessandro Rambaldi

Bologna
Istituto di Ematologia "Lorenzo e A. Seragnoli"
Università degli Studi di Bologna
Policlinico S. Orsola Malpighi
Gianantonio Rosti

Brescia
USD Trapianti di midollo per adulti
Cattedra di Ematologia
Università degli Studi di Brescia
Domenico Russo

Cagliari
CTMO - Ematologia - Ospedale "Binaghi
Giorgio La Nasa
Cagliari ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Emilio Usala

Campobasso
U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche
Sergio Storti

Catania
Università di Catania
Cattedra di Ematologia
Ospedale "Ferrarotto"
Francesco Di Raimondo

Catanzaro
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Stefano Molica

Civitanova Marche
U.O. di Medicina Interna
ASUR Marche 8
Ospedale Civile
Riccardo Centurione

Cona
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna
Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Francesco Cavazzini

Cosenza
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
Eugenio Lucia

Cuneo
S.C. Ematologia ASO S. Croce e Carle
Davide Rapezzi

Ferrara
Arcispedale Sant'Anna Dipartimento di Scienze Mediche
Sezione di Ematologia e Fisiopatologia dell'Emostasi
Francesco Cavazzini

Firenze
Unità di Ricerca e di Malattie del sangue
Ematologia San Luca Vecchio Pad. 16
Antonella Gozzini

Foggia
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
Silvana Franca Capalbo

Genova
IRCCS AOU San Martino-
IST.Clinica Ematologica
Marco Gobbi

Latina
UOC di Ematologia con trapianto Ospedale S. Maria Goretti
Giuseppe Cimino

Lecce
ASL Le/1 P.O. Vito Fazzi
U.O. di Ematologia ed UTIE
Nicola Di Renzo

Meldola
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST IRCCS
Alessandro Lucchesi

Messina
Azienda Ospedaliera Universitaria Policlinico G. Martino Dipartimento di Medicina Interna
U.O. Messina
Caterina Musolino

Messina
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" P.O. Papardo
Donato Mannina

Mestre
U.O. di Ematologia
Ospedale dell'Angelo
Renato Bassan

Milano
Unità Trapianto di Midollo Ist. Nazionale Tumori
Francesco Spina

Milano
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Alessandra Iurlo

Milano
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
Ester Pungolino

Modena
UO Ematologia - AOU Policlinico di Modena
Roberto Marasca

Napoli
Azienda Ospedaliera Universitaria
Università degli Studi di Napoli "Federico II"
Facoltà di Medicina e Chirurgia
Fabrizio Pane

Napoli
Ospedale San Gennaro
ASL Napoli 1
Lucia Mastrullo

Napoli
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Mario Annunziata

Novara
S.C.D.U. Ematologia
DIMECS e Dipartimento Oncologico
Università del Piemonte Orientale Amedeo Avogadro
Monia Lunghi

Nuoro
U.O. CTMO Ematologia - Osp. S. Francesco
Alessandro Murgia

Orbassano
Dip. di Scienze Cliniche e Biologiche
Ospedale S. Luigi Gonzaga-Medicina Interna 2
Giovanna Rege Cambrin

Padova
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Gianni Binotto

Pagani (SA)
U.O. di Oncoematologia di Nocera Inferiore-plesso ospedaliero "A. Tortora" di Pagani del DEA Nocera-Pagani
Paolo Danise

Palermo
Ospedali Riuniti "Villa Sofia-Cervello"
Francesco Fabbiano

Palermo
U.O. di Ematologia con trapianto
Dipart. Biomedico di Medicina Interna A.U. Policlinico "Paolo Giaccone"
Sergio Siragusa

Parma
Cattedra di Ematologia CTMO Università degli Studi di Parma
Monica Crugnola

Pesaro
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
Giuseppe Visani

Pescara
U.O. Ematologia Clinica - Azienda USL di Pescara
Paolo Di Bartolomeo

Piacenza
Unità Operativa
Dipartimento di Oncologia ed Ematologia
AUSL Ospedale G. da Saliceto
Daniele Vallisa

Potenza
Ematologia - Ospedale San Carlo
Michele Pizzuti

Ravenna
Dipartimento Oncologico
Ospedale S.Maria delle Croci
Maria Salvucci

Reggio Calabria
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Bruno Martino

Reggio Emilia
Unità Operativa Complessa di Ematologia
Arcispedale S. Maria Nuova
Paolo Avanzini

Rimini
Ematologia di Rimini - Ospedale "Infermi" – ASL Romagna
Anna Lia Molinari

Roma
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza
Seconda Facoltà di Medicina e Chirurgia
Agostino Tafuri

Roma
Divisione Ematologia
Università Campus Bio-Medico
Marianna De Muro

Roma
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
Simona Sica

Roma
UOC Pronto Soccorso
Dipartimento Biotecnologie Cellulari ed Ematologia
Università degli Studi di Roma "Sapienza"
Massimo Breccia

Roma
U.O.C. Ematologia - Ospedale S. Eugenio
Elisabetta Abruzzese

Roma
Università degli Studi -
Policlinico di Tor Vergata
Maria Cantonetti

Rossano (CS)
Unità Operativa di Oncologia -
Presidio Ospedaliero N. Giannetasio - Azienda ASL 3
Francesco Iuliano

Salerno
UOC di Ematologia e Trapianti di Cellule Staminali Emopoietiche - AOU San Giovanni di Dio e Ruggi D'Aragona
Carmine Selleri
San Giovanni Rotondo
Istituto di Ematologia
IRCCS Ospedale Casa Sollievo della Sofferenza
Nicola Cascavilla

Sassari
Ematologia
Dipartimento di Medicina Clinica e Sperimentale
Claudio Fozza

Siena
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Monica Bocchia

Terni
A.O. Santa Maria
Terni S.C Oncoematologia
Anna Marina Liberati

Torino
Divisione di Ematologia dell' Università degli Studi di Torino - "Città della Salute e della Scienza di Torino"
Dario Ferrero

Torino
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Patrizia Pregno

Torino
Struttura Complessa a Dir. Universitaria-Ematologia e Terapie Cellulari
A.S.O. Ordine Mauriziano, P.O. Umberto I
Ospedale Torino
Carmen Fava

Treviso
U.L.S.S. 9 UOC Ematologia -
Ospedale Ca' Foncello
Filippo Gherlinzoni

Udine
Clinica Ematologica
Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria
Mauro Tiribelli

Varese
Medicina Interna I - Ospedale di Circolo
Leonardo Campiotti

Verona
Università degli Studi di Verona
A. O. - Istituti Ospitalieri di Verona
Div. di Ematologia
Policlinico G.B. Rossi
Massimiliano Bonifacio

Vicenza
ULSS N.6 Osp. S. Bortolo
Eros Di Bona

 

Netherlands

Amersfoort
Meander MC
Dr. S. K. Klein

Amsterdam
VUMC
Dr. JJWM Janssen

Delft
Reinier de Graaf Gasthuis
Dr. E Posthuma

Den Bosch
Jeroen Bosch Ziekenhuis
Dr. A. Herbers

Dordrecht
A. Schweitzer ZH, Dordwijk
Dr. P. Westerveel

Heerlen-Sittard-Geleen
Zuyderland Medical Center
Dr. G. Jie

Hoofddorp
Spaarne Ziekenhuis
I. Houtenbos

Leiden
Leids Universitair Medisch Centrum
Dr. P. Balen

Nijmegen
Radboudumc
Prof. Dr. N. Blijlevens

Utrecht
UMCU
Dr. Petersen

Zwolle
Isala
Dr. M. van Markwijk Kooy

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

 

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

 

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

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