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

Primary Purpose

Chronyc Myeloid Leukemia

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Imatinib
Nilotinib
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronyc Myeloid Leukemia focused on measuring Chronic myeloid leukemia, Nilotinib, Imatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a confirmed diagnosis of BCR/ABL+ CML in chronic phase

Documented chronic phase CML must meet all the following criteria:

< 15% blasts in peripheral blood < 30% blasts plus promyelocytes in peripheral blood < 20% basophils in the peripheral blood

  • 100 x 109/L (≥ 100,000/mm3) platelets

    • Age ≥18
    • ECOG performance status of 0-2
    • Evidence of typical BCR-ABL transcripts which are amenable to standardized RQ-PCR
    • Adequate end organ function as defined by:

Total bilirubin < 1.5 x ULN (ULN = upper limit of normal in a local institution lab).

Does not apply to patients with isolated hyperbilirubinemia (e.g., Gilbert's disease) grade < 3 SGOT (AST) and SGPT (ALT) ≤ 3 x ULN Serum amylase and lipase ≤ 2 x ULN Alkaline phosphatase ≤ 2.5 x ULN Serum creatinine < 1.5 x ULN

  • Having completed the QoL baseline evaluation (i.e., before randomization)
  • Written informed consent prior to any study procedures.

Exclusion Criteria:

  • Expression of any atypical BCR-ABL transcripts, instead of the classical P210-encoding type with the e13a2 or the e14a2 junction at screening.
  • Previous treatment with BCR-ABL inhibitors for a period longer than 1 month.
  • Previous anticancer agents (hydroxyurea, anagrelide, interferon) for CML for a time longer than three months.
  • Poorly controlled diabetes mellitus (defined as HbA1c >8%).
  • Prior documented history of coronary heart disease, including myocardial infarction, coronary bypass, coronary stent, and symptomatic angina:

LVEF <45% or below the institutional lower limit of the normal range (whichever ishigher) Complete left bundle branch block Right bundle branch block plus left anterior or posterior hemiblock Use of a ventricular-paced pacemaker Congenital long QT syndrome or a known family history of long QT syndrome History of or presence of clinically significant ventricular or atrial tachyarrhythmias

  • Atrial fibrillation or flutter
  • Clinically significant resting bradycardia (< 50 beats per minute)

  • QTc > 450 msec on the average of three serial screening ECGs (using the QTcF formula). If QTcF > 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and the patient re-tested History or clinical signs of myocardial infarction within 12 months of study entry History of unstable angina within 12 months of study entry Other clinically significant heart disease (e.g. congestive heart failure)

    • Uncontrolled hypertension is not a heart disease.
    • History of peripheral arterial occlusive disease.
    • History of acute pancreatitis within 12 months of study entry, or a past medical history of chronic pancreatitis.
    • Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers which cannot be either discontinued or switched to a different medication prior to starting study drug.
    • Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and for which cannot be either safely discontinued or switched to a different medication prior to starting study drug.

Sites / Locations

  • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
  • Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi G. Salesi
  • Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
  • Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
  • Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto
  • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
  • UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
  • Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - Barletta - Uo Ematologia
  • Ematologia Torre 6 piano 4 - ASST Papa Giovanni XXIII
  • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
  • USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
  • ASL N.8 -Ospedale A. Businco
  • Cagliari CTMO - Ematologia - Ospedale "Binaghi"
  • Gemelli Molise - Campobasso - Uosd Onco-Ematologia
  • U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo
  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
  • Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
  • U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
  • Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
  • Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia
  • S.C. Ematologia ASO S. Croce e Carle
  • Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
  • Aou Ospedali Riuniti - Foggia - Uoc Ematologia
  • Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
  • IRCCS_AOU San Martino-IST.Clinica Ematologica
  • Asl Latina, Presidio Ospedaliero Nord - Ospedale Santa Maria Goretti - Uoc Ematologia
  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
  • I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
  • Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
  • Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
  • U.O. di Ematologia- Ospedale dell'Angelo - Mestre
  • Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
  • Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
  • UO Ematologia - AOU Policlinico di Modena
  • Asl Napoli 1 Centro, Presidio Ospedaliero Ascalesi - Ospedale S.Maria Di Loreto Nuovo
  • Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
  • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
  • Ospedale San Gennaro - ASL Napoli 1
  • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
  • U.O. CTMO Ematologia - Osp. S. Francesco
  • Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
  • Aou Di Padova - Uo Ematologia
  • Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
  • Ospedali Riuniti "Villa Sofia-Cervello"
  • U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone"
  • Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
  • Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
  • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
  • Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
  • Az.Ospedaliera S.G.Moscati
  • Dipartimento Oncologico - Ospedale S.Maria delle Croci
  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
  • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
  • Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
  • Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
  • Divisione Ematologia - Università Campus Bio-Medico
  • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
  • UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
  • U.O.C. Ematologia - Ospedale S. Eugenio
  • Unità Operativa di Oncologia Giovanni Paolo II "Vito Fazzi"
  • Aulss 5 Polesana, Presidio Ospedaliero Di Rovigo - Uosd Ematologia
  • Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
  • Ematologia - Dipartimento di Medicina Clinica e Sperimentale
  • Ospedale Di Sassuolo Spa - Ematologia
  • Aou Senese - Uoc Ematologia E Trapianti
  • A.O. Santa Maria - Terni S.C Oncoematologia
  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
  • Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia
  • Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
  • Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine
  • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
  • Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
  • ULSS N.6 Osp. S. Bortolo
  • Meander Mc - Paesi Bassi
  • Vumc - Paesi Bassi
  • Reinier de Graaf Gasthuis
  • A. Schweitzer Zh, Dordwijk - Paesi Bassi
  • Zuyderland Medical Center - Paesi Bassi
  • Spaarne Ziekenhuis - Paesi Bassi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Imatinib + Nilotinib

Nilotinib

Arm Description

Outcomes

Primary Outcome Measures

Number of of patients with molecular response
Number of patients who remain in sustained treatment free remission, without molecular relapse

Secondary Outcome Measures

Number of patients with molecular response
Number of patiens in progression-free survival
Number of patients with major molecular response
Number of toxic events
Number of patients who discontinue treatment
Number of patients with quality of life differences between treatment arms over time
To assess the patient-reported quality of life (QoL) and adherence to therapy at baseline and at 6, 12, 18, 24, 27, 33, 36, 39, 42, 48, 51, 54 and 60 months in the following QoL scales: Fatigue, Physical Functioning and Global Health Status/QoL (outcome measure: EORTC QLQ-C30), Impact on Daily Life and Symptom Burden (outcome measure: EORTC CML-24), Burden of Illness (outcome measure: EORTC QLQ-ELD14).

Full Information

First Posted
November 10, 2015
Last Updated
January 4, 2022
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT02602314
Brief Title
Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia
Acronym
SUSTRENIM
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 11, 2016 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in the case of absence of optimal response as defined by the ELN criteria.
Detailed Description
This is a prospective, interventional, randomized, two arms, phase IV study evaluating both the depth of the molecular response and the rate of treatment free remission rate in newly diagnosed CP-CML patients treated with NIL or IM followed by switch to NIL in absence of optimal response (defined according the ELN 2013 criteria) as per clinical practice. The enrolled patients will be randomized 1:1 between NIL and IM. Patients will be stratified according to the Sokal risk score to high versus intermediate/low risk groups. Newly diagnosed patients will be treated according to the registered dose of NIL and IM for frontline chronic phase CML (300 mg BID and 400 mg OAD, respectively). The patients intolerant to IM and the patients without optimal response to IM at 3 months, at 6 months, at 12 months (except the patients with progression to accelerated or blastic phase) will be switched to NIL second line. The absence of optimal response is defined by at least one of the following ELN criteria: a) Absence of Complete Hematologic Response at 3 months or thereafter; b) Absence of Partial Cytogenetic Response (> 35% Ph+ metaphases) at 3 months; c) BCR-ABL transcript level > 10% according to the IS at 3 months; d) Absence of Complete Cytogenetic Response (> 1% Ph+ metaphases) at 6 months; e) BCR-ABL transcript level > 1% according to the IS at 6 months; f) Absence of Major Molecular Response (MR3.0, transcript level > 0.1% according to the IS) at 12 months. Treatment choice for the patients with progression to advanced disease phase while on IM and for the patients intolerant to or resistant (including progressions to advanced phases) to NIL will be up to the principal investigator of the participating Center. However, information concerning the course and outcome of these patients will be collected and recorded for at least 5 years, and they could be enrolled in investigational studies promoted by GIMEMA or other sponsors. After the induction of deep molecular remission phase of therapy, i.e. the first two years of the study, residual disease will be closely monitored (quarterly) by Q-PCR assays. All the patients who obtain a reduction greater than 4.0 logs of residual disease (MR4.0) within the first three years of treatment, and maintain this level of response in all the subsequent tests up to the end of the fourth years of therapy qualify for the discontinuation phase of the study. Therefore, all patients who are in MR4.0 after a four-year period of TKI treatment, that must include in its final part at least one years of maintained MR4.0, defined as 12-month period during which the MR4.0 never is lost in 4 consecutive MRD analyses at three-monthly intervals, will enter the treatment free remission (TFR) phase of the study. In case of loss of MR3.0, the last assumed TKI will be resumed at the same dose. All patients, including those who do not match the criteria for discontinuation of TKI treatment, will continue the assigned treatment and will be followed for 5 years, starting from the date of enrolment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronyc Myeloid Leukemia
Keywords
Chronic myeloid leukemia, Nilotinib, Imatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imatinib + Nilotinib
Arm Type
Experimental
Arm Title
Nilotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Imatinib
Intervention Type
Drug
Intervention Name(s)
Nilotinib
Primary Outcome Measure Information:
Title
Number of of patients with molecular response
Time Frame
At 24 months from study entry
Title
Number of patients who remain in sustained treatment free remission, without molecular relapse
Time Frame
After 12 months after entering the treatment-free-remission (TFR) phase
Secondary Outcome Measure Information:
Title
Number of patients with molecular response
Time Frame
4 years after study entry
Title
Number of patiens in progression-free survival
Time Frame
5 years after study entry
Title
Number of patients with major molecular response
Time Frame
At 1, 2, 3 and 4 years from study entry
Title
Number of toxic events
Time Frame
At 5 years from study entry
Title
Number of patients who discontinue treatment
Time Frame
At 5 years from study entry
Title
Number of patients with quality of life differences between treatment arms over time
Description
To assess the patient-reported quality of life (QoL) and adherence to therapy at baseline and at 6, 12, 18, 24, 27, 33, 36, 39, 42, 48, 51, 54 and 60 months in the following QoL scales: Fatigue, Physical Functioning and Global Health Status/QoL (outcome measure: EORTC QLQ-C30), Impact on Daily Life and Symptom Burden (outcome measure: EORTC CML-24), Burden of Illness (outcome measure: EORTC QLQ-ELD14).
Time Frame
At baseline and at 3, 6, 12, 18, 24, 30, 36, 42, 48, and 60 months from study entry.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a confirmed diagnosis of BCR/ABL+ CML in chronic phase Documented chronic phase CML must meet all the following criteria: < 15% blasts in peripheral blood < 30% blasts plus promyelocytes in peripheral blood < 20% basophils in the peripheral blood 100 x 109/L (≥ 100,000/mm3) platelets Age ≥18 ECOG performance status of 0-2 Evidence of typical BCR-ABL transcripts which are amenable to standardized RQ-PCR Adequate end organ function as defined by: Total bilirubin < 1.5 x ULN (ULN = upper limit of normal in a local institution lab). Does not apply to patients with isolated hyperbilirubinemia (e.g., Gilbert's disease) grade < 3 SGOT (AST) and SGPT (ALT) ≤ 3 x ULN Serum amylase and lipase ≤ 2 x ULN Alkaline phosphatase ≤ 2.5 x ULN Serum creatinine < 1.5 x ULN Having completed the QoL baseline evaluation (i.e., before randomization) Written informed consent prior to any study procedures. Exclusion Criteria: Expression of any atypical BCR-ABL transcripts, instead of the classical P210-encoding type with the e13a2 or the e14a2 junction at screening. Previous treatment with BCR-ABL inhibitors for a period longer than 1 month. Previous anticancer agents (hydroxyurea, anagrelide, interferon) for CML for a time longer than three months. Poorly controlled diabetes mellitus (defined as HbA1c >8%). Prior documented history of coronary heart disease, including myocardial infarction, coronary bypass, coronary stent, and symptomatic angina: LVEF <45% or below the institutional lower limit of the normal range (whichever ishigher) Complete left bundle branch block Right bundle branch block plus left anterior or posterior hemiblock Use of a ventricular-paced pacemaker Congenital long QT syndrome or a known family history of long QT syndrome History of or presence of clinically significant ventricular or atrial tachyarrhythmias Atrial fibrillation or flutter Clinically significant resting bradycardia (< 50 beats per minute) QTc > 450 msec on the average of three serial screening ECGs (using the QTcF formula). If QTcF > 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and the patient re-tested History or clinical signs of myocardial infarction within 12 months of study entry History of unstable angina within 12 months of study entry Other clinically significant heart disease (e.g. congestive heart failure) Uncontrolled hypertension is not a heart disease. History of peripheral arterial occlusive disease. History of acute pancreatitis within 12 months of study entry, or a past medical history of chronic pancreatitis. Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers which cannot be either discontinued or switched to a different medication prior to starting study drug. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and for which cannot be either safely discontinued or switched to a different medication prior to starting study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrizio Pane
Organizational Affiliation
Università Federico II of Naples
Official's Role
Study Chair
Facility Information:
Facility Name
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
City
Alessandria
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi G. Salesi
City
Ancona
Country
Italy
Facility Name
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
City
Ascoli Piceno
Country
Italy
Facility Name
Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
City
Asti
Country
Italy
Facility Name
Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto
City
Avellino
Country
Italy
Facility Name
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
City
Bari
Country
Italy
Facility Name
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
City
Bari
Country
Italy
Facility Name
Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - Barletta - Uo Ematologia
City
Barletta
Country
Italy
Facility Name
Ematologia Torre 6 piano 4 - ASST Papa Giovanni XXIII
City
Bergamo
Country
Italy
Facility Name
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
City
Bologna
Country
Italy
Facility Name
USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
City
Brescia
Country
Italy
Facility Name
ASL N.8 -Ospedale A. Businco
City
Cagliari
Country
Italy
Facility Name
Cagliari CTMO - Ematologia - Ospedale "Binaghi"
City
Cagliari
Country
Italy
Facility Name
Gemelli Molise - Campobasso - Uosd Onco-Ematologia
City
Campobasso
Country
Italy
Facility Name
U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo
City
Castelfranco Veneto
Country
Italy
Facility Name
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
City
Catania
Country
Italy
Facility Name
Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
City
Catanzaro
Country
Italy
Facility Name
U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
City
Civitanova Marche
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
City
Cona
Country
Italy
Facility Name
Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia
City
Cosenza
Country
Italy
Facility Name
S.C. Ematologia ASO S. Croce e Carle
City
Cuneo
Country
Italy
Facility Name
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
City
Firenze
Country
Italy
Facility Name
Aou Ospedali Riuniti - Foggia - Uoc Ematologia
City
Foggia
Country
Italy
Facility Name
Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
City
Genova
Country
Italy
Facility Name
IRCCS_AOU San Martino-IST.Clinica Ematologica
City
Genova
Country
Italy
Facility Name
Asl Latina, Presidio Ospedaliero Nord - Ospedale Santa Maria Goretti - Uoc Ematologia
City
Latina
Country
Italy
Facility Name
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
City
Lecce
Country
Italy
Facility Name
I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
City
Meldola
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
City
Messina
Country
Italy
Facility Name
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
City
Messina
Country
Italy
Facility Name
U.O. di Ematologia- Ospedale dell'Angelo - Mestre
City
Mestre
Country
Italy
Facility Name
Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
City
Milano
Country
Italy
Facility Name
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
City
Milano
Country
Italy
Facility Name
UO Ematologia - AOU Policlinico di Modena
City
Modena
Country
Italy
Facility Name
Asl Napoli 1 Centro, Presidio Ospedaliero Ascalesi - Ospedale S.Maria Di Loreto Nuovo
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
City
Napoli
Country
Italy
Facility Name
Ospedale San Gennaro - ASL Napoli 1
City
Napoli
Country
Italy
Facility Name
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
City
Novara
Country
Italy
Facility Name
U.O. CTMO Ematologia - Osp. S. Francesco
City
Nuoro
Country
Italy
Facility Name
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
City
Orbassano
Country
Italy
Facility Name
Aou Di Padova - Uo Ematologia
City
Padova
Country
Italy
Facility Name
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
City
Pagani
Country
Italy
Facility Name
Ospedali Riuniti "Villa Sofia-Cervello"
City
Palermo
Country
Italy
Facility Name
U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone"
City
Palermo
Country
Italy
Facility Name
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
City
Parma
Country
Italy
Facility Name
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
City
Pesaro
Country
Italy
Facility Name
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
City
Pescara
Country
Italy
Facility Name
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
City
Piacenza
Country
Italy
Facility Name
Az.Ospedaliera S.G.Moscati
City
Potenza
Country
Italy
Facility Name
Dipartimento Oncologico - Ospedale S.Maria delle Croci
City
Ravenna
Country
Italy
Facility Name
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
City
Reggio Calabria
Country
Italy
Facility Name
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
City
Rimini
Country
Italy
Facility Name
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
City
Roma
Country
Italy
Facility Name
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
City
Roma
Country
Italy
Facility Name
Divisione Ematologia - Università Campus Bio-Medico
City
Roma
Country
Italy
Facility Name
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
City
Roma
Country
Italy
Facility Name
UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
City
Roma
Country
Italy
Facility Name
U.O.C. Ematologia - Ospedale S. Eugenio
City
Rome
Country
Italy
Facility Name
Unità Operativa di Oncologia Giovanni Paolo II "Vito Fazzi"
City
Rossano
Country
Italy
Facility Name
Aulss 5 Polesana, Presidio Ospedaliero Di Rovigo - Uosd Ematologia
City
Rovigo
Country
Italy
Facility Name
Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
City
Salerno
Country
Italy
Facility Name
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
Ematologia - Dipartimento di Medicina Clinica e Sperimentale
City
Sassari
Country
Italy
Facility Name
Ospedale Di Sassuolo Spa - Ematologia
City
Sassuolo
Country
Italy
Facility Name
Aou Senese - Uoc Ematologia E Trapianti
City
Siena
Country
Italy
Facility Name
A.O. Santa Maria - Terni S.C Oncoematologia
City
Terni
Country
Italy
Facility Name
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
City
Torino
Country
Italy
Facility Name
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
City
Torino
Country
Italy
Facility Name
Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia
City
Torino
Country
Italy
Facility Name
Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
City
Treviso
Country
Italy
Facility Name
Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine
City
Udine
Country
Italy
Facility Name
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
City
Verona
Country
Italy
Facility Name
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
City
Vicenza
Country
Italy
Facility Name
ULSS N.6 Osp. S. Bortolo
City
Vicenza
Country
Italy
Facility Name
Meander Mc - Paesi Bassi
City
Amersfoort
Country
Netherlands
Facility Name
Vumc - Paesi Bassi
City
Amsterdam
Country
Netherlands
Facility Name
Reinier de Graaf Gasthuis
City
Delft
Country
Netherlands
Facility Name
A. Schweitzer Zh, Dordwijk - Paesi Bassi
City
Dordrecht
Country
Netherlands
Facility Name
Zuyderland Medical Center - Paesi Bassi
City
Heerlen
Country
Netherlands
Facility Name
Spaarne Ziekenhuis - Paesi Bassi
City
Hoofddorp
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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

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