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Front-line Nilotinib Treatment of BCR-ABL+ Chronic Myeloid Leukaemia in Chronic Phase (CML0912)

This study is currently recruiting participants.
Verified August 2017 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
ClinicalTrials.gov Identifier:
NCT01699217
First Posted: October 3, 2012
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
  Purpose
The GIMEMA CML Working Party promotes a multicentre, observational, prospective study of CML patients treated frontline with NIL. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early CP.

Condition
Chronic Phase Philadelphia Positive BCR-ABL Positive Chronic Myeloid Leukaemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Front-line Nilotinib Treatment of BCR-ABL+ Chronic Myeloid Leukaemia in Chronic Phase. An Observational Multicentre Study of the GIMEMA CML WP.

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • The rate of confirmed MR4 [ Time Frame: At 24 months from study entry ]

Secondary Outcome Measures:
  • The rate of MMR [ Time Frame: At 24, 36, 48, and 60 months from study entry. ]
  • The rate of MR4 [ Time Frame: At 24, 36, 48, and 60 months from study entry. ]
  • The rate of MR4.5 [ Time Frame: At 24, 36, 48, and 60 months from study entry. ]
  • The rate of confirmed MR4 [ Time Frame: At 36, 48, and 60 months from study entry. ]
  • The rate of stable MR4 [ Time Frame: At 24, 36, 48, and 60 months from study entry ]
    (at least three PCR results with MR4 within the last year [± 2 months] and no results > 0.01% during the same period).

  • The rate of stable MR4.5 [ Time Frame: At 24, 36, 48, and 60 months from study entry ]
    (at least three PCR results with MR4.5 within the last year [± 2 months] and no results > 0.0032% during the same period)

  • The rate of confirmed loss of MMR (MR3) [ Time Frame: At 60 months from study entry ]
  • The rate of confirmed loss of MMR [ Time Frame: At one year from study entry ]
  • The rate of Complete Cytogenetic Response [ Time Frame: At one year. ]
  • The cumulative rate of permanent NIL discontinuation [ Time Frame: At 5 years from study entry ]
    (for failure [defined according to ELN recommendations 2009], intolerance, and death for any reason; not for patients in ≥ MR4 entering clinical trials exploring nilotinib discontinuation)


Estimated Enrollment: 120
Actual Study Start Date: June 2013
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Detailed Description:

The primary objective of the study is to describe the stability of molecular response with NIL as frontline therapy in newly diagnosed, unselected, CP CML patients, in an independent, investigator-initiated observational study. Imatinib mesylate (IM), a protein tyrosine kinase inhibitor (TKI) targeting BCR-ABL, has become in the last decade the standard of care for Chronic Myeloid Leukaemia (CML) in chronic phase (CP)1,2. Nilotinib (NIL) is a second generation TKI, effective in IM-resistant and IM-intolerant patients, which demonstrated superior efficacy to IM in early CP BCR-ABL+ CML patients3. Currently, the most important target of the treatment of CML with TKIs is the major molecular response (MMR), defined as a ≥ 3 log reduction in BCR-ABL/ABL transcript level, marker of better long-term outcome. With imatinib therapy, achieving a MMR correlates with an improved probability of a durable cytogenetic remission30. Results from IRIS suggest that a MMR after 12 months of imatinib therapy may be a marker of stable response. Further on, the IRIS study showed that patients with a MMR after 12 months of therapy had a significantly better probability of disease-free survival compared with those in complete cytogenetic remission, but not in MMR31. Moreover, obtaining an undetectable BCR-ABL transcript level is extremely relevant in order to consider TKIs discontinuation. This condition is known as "Complete Molecular Response" (CMR) and is further defined according to the sensitivity achieved (for the definition see the "Criteria of evaluation" section). As far as treatment discontinuation, two experiences have been published so far, aimed at evaluating the persistence of the CMR after imatinib discontinuation. The first was a pilot study32 where 12 patients were included. These 12 patients discontinued imatinib after at least 2 years of CMR (median duration of negativity, 32 months). Six patients displayed a molecular relapse with a detectable BCR-ABL transcript at 1, 1, 2, 3, 4, and 5 months. Imatinib was then reintroduced and led to a novel molecular response. Six other patients (50%) still have an undetectable level of BCR-ABL transcript after a median follow-up of 18 months (range, 9-24 months). The results of this pilot trial have been confirmed and extended in a second trial, the STIM trial33: 100 patients were enrolled, median follow-up 17 months, 69 patients with at least 12 months follow-up: 42 (61%) of these 69 patients relapsed (40 before 6 months, one patient at month 7, and one at month 19). At 12 months, the probability of persistent CMR for these 69 patients was 41% (95% CI 29-52). All patients who relapsed responded to reintroduction of imatinib. An increase of the CMR rate could possibly translate in a higher proportion of patients candidate to stopping anti-CML treatment, with higher probability of remaining disease-free in the long term. The advantages of this possible future scenario could be: first, the possibility of treatment discontinuation at least in patients with chronic clinical adverse events; second, a potential reduction of the costs of TKI treatment (after the introduction of TKI, the costs of CML treatment is increasing year by year, with the increasing prevalence of CML patients). Standardized molecular monitoring has become widely available in Europe through the efforts of EUTOS cooperation19 and now allows for the generation of comparable data on the residual disease using recalculation on the international scale despite these data being analyzed in many different laboratories. These advances in the standardization of molecular responses and the improvement of targeted therapy have allowed for comparable response assessment across Italian Centres and early treatment optimization of patients.

In summary, 1) monitoring of molecular response and of deep and sustained molecular response, provides a straightforward opportunity to assess patients' response and possible prognosis in the use of targeted therapy. 2) Most data on second generation TKIs are from company-sponsored studies generally implemented in selected referral centres. 3) The detailed description of the kinetic of the molecular response and, particularly, the rate of stable MR4, potentially related in turn with a subsequent treatment discontinuation, within the frame of a long-term post-marketing surveillance observational trial offered to all eligible patients followed at a nation-wide, independent multicentre group is the core distinctive feature of this observational trial.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Treatment decision is at the discretion of the investigator and must not be made on the basis of this observational study. Patients should have their treatment initiated in accordance with the summary of product characteristics.
Criteria

Inclusion Criteria:

  • Age: >=18 years;
  • Patients with chronic phase Ph+ and/or BCR-ABL+ CML, newly diagnosed (less than 6 months);
  • Prior treatment with Hydroxyurea or Anagrelide is allowed;
  • Prior treatment with IM for less than 30 days is allowed;
  • Signed written informed const according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

  • Patients who are pregnant (negative pregnancy test is requested within 2 days before nilotinib start) or breast feeding, or adults of reproductive potential not employing an effective method of birth control.
  • Newly diagnosed Ph+ and/or BCR-ABL+ CML patients in advanced phases (accelerated or blastic phase).
  • Prior treatment with nilotinib, dasatinib, or other tyrosine-kinase inhibitors.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699217


Contacts
Contact: Paola Fazi, Dr. p.fazi@gimema.it
Contact: Enrico Crea e.crea@gimema.it

  Hide Study Locations
Locations
Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo Not yet recruiting
Alessandria, Italy
Contact: Massimo Pini, Dr.         
Principal Investigator: Massimo Pini, Dr.         
Sub-Investigator: Gioacchino Catania, Dr.         
Azienda Ospedaliera Nuovo Ospedale "Torrette" Recruiting
Ancona, Italy
Contact: Serena Rupoli, Dr.         
Principal Investigator: Serena Rupoli, Dr.         
Principal Investigator: Anna Rita Scortechini, Dr.         
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni" Not yet recruiting
Ascoli, Italy
Contact: Catia Bigazzi, Dr.         
Principal Investigator: Catia Bigazzi, Dr.         
Ematologia con trapianto-Università degli Studi di Bari Aldo Moro Not yet recruiting
Bari, Italy
Contact: Giorgina Specchia, Pr.         
Principal Investigator: Giorgina Specchia, Pr.         
Principal Investigator: Antonella Russo, Dr.         
Policlinico Sant'Orsola Malpighi Not yet recruiting
Bologna, Italy
Contact: Giannantonio Rosti         
Principal Investigator: Giannantonio Rosti         
USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia Not yet recruiting
Brescia, Italy
Contact: Domenico Russo         
Principal Investigator: Domenico Russo, Dr.         
Sub-Investigator: Michele Malagola, Dr.         
Divisione di Ematologia Ospedale A. Perrino Not yet recruiting
Brindisi, Italy
Contact: Giovanni Quarta, Dr.         
Principal Investigator: Giovanni Quarta, Dr.         
Sub-Investigator: Mariella Girasoli, Dr.         
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO Not yet recruiting
Cagliari, Italy
Contact: Emilio Usala, Dr.         
Principal Investigator: Emilio Usala, Dr.         
Sub-Investigator: Maria Pina Simula, Dr.         
U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche Not yet recruiting
Campobasso, Italy
Contact: Sergio Storti, Dr.         
Principal Investigator: Sergio Storti, Dr.         
Sub-Investigator: Cristiana Gasbarrino, Dr.         
US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo Not yet recruiting
Castelfranco Veneto, Italy
Contact: Giuseppe Tagariello, Dr.         
Principal Investigator: Giuseppe Tagariello, Dr.         
Sub-Investigator: Roberto Sartori, Dr.         
ezione di Ematologia C.T.M.O. Istituti Ospitalieri Not yet recruiting
Cremona, Italy
Contact: Francesco Lanza, Dr.         
Principal Investigator: Francesco Lanza, Dr.         
Ospedale Santa Croce Divisione di Ematologia Cuneo Recruiting
Cuneo, Italy
Contact: Davide Rapezzi, Dr.         
Principal Investigator: Davide Rapezzi, Dr.         
Sub-Investigator: Andrea Gallamini, Dr.         
Policlinico di Careggi, Università delgi studi di Firenze Not yet recruiting
Firenze, Italy
Contact: Alberto BOSI         
Principal Investigator: Alberto BOSI, Dr.         
Sub-Investigator: Antonella Gozzini, Dr.         
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria Not yet recruiting
Foggia, Italy
Contact: Silvana Franca, Dr.         
Principal Investigator: Silvana Franca, Dr.         
Sub-Investigator: Giuseppina Spinosa, Dr.         
Clinica Ematologica - DiMI - Università degli Studi di Genova Not yet recruiting
Genova, Italy
Contact: Marco Gobbi, Dr.         
Principal Investigator: Marco Gobbi, Dr.         
Sub-Investigator: Micaela Bergamaschi, Dr.         
IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente Not yet recruiting
Genova, Italy
Contact: Angelo Michele Carella, Dr.         
Principal Investigator: Angelo Michele Carella, Dr.         
SOC Ematologia e Centro Trasfusionale Ospedale di Ivrea - ASL TO4 Not yet recruiting
Ivrea, Italy
Contact: Aitoro Soc, Dr.         
Principal Investigator: Aitoro Soc, Dr.         
Sub-Investigator: Gabriella Tomei, Dr.         
Divisione di Ematologia Ospedale "Santa Maria Goretti" Not yet recruiting
Latina, Italy
Contact: Angelo De Blasio, Dr.         
Principal Investigator: Angelo De Blasio, Dr.         
Sub-Investigator: Matteo Pacilli, Dr.         
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina Not yet recruiting
Messina, Italy
Contact: Caterina Musolino, Pr.         
Principal Investigator: Caterina Musolino, Pr.         
Sub-Investigator: Sabina Russo, Dr.         
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" Recruiting
Messina, Italy
Contact: Maura Brugiatelli, Pr.         
Principal Investigator: Maura Brugiatelli, Pr.         
Sub-Investigator: Laura Nocilli, Dr.         
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele Recruiting
Milano, Italy
Contact: Fabio Ciceri, Dr.         
Principal Investigator: Fabio Ciceri, Dr.         
Sub-Investigator: Francesca Lunghi, Dr.         
UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico Recruiting
Milano, Italy
Contact: Alessandra Iurlo, Dr.         
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Not yet recruiting
Napoli, Italy
Contact: Felicetto Ferrara, Dr.         
Principal Investigator: Felicetto Ferrara, Dr.         
Sub-Investigator: Mario Annunziata, Dr.         
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia Not yet recruiting
Napoli, Italy
Contact: Fabrizio Pane, Dr.         
Principal Investigator: Fabrizio Pane, Pr.         
Sub-Investigator: Luigia Luciano, Dr.         
Ospedale San Gennaro - ASL Napoli 1 Not yet recruiting
Napoli, Italy
Contact: Lucia Mastrullo, Dr.         
Principal Investigator: Lucia Mastrullo, Dr.         
Sub-Investigator: Maria Rosaria Esposito, Dr.         
Sez. di Ematologia Clinica Ospedale San Francesco Not yet recruiting
Nuoro, Italy
Contact: Delia Noli, Dr.         
Principal Investigator: Delia Nolo, Dr.         
Sub-Investigator: Rosario Di Maggio, Dr.         
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2 Prof. Giuseppe Saglio Not yet recruiting
Orbassano, Italy
Contact: Giovanna Rege, Dr.         
Principal Investigator: Giovanna Rege, Dr.         
Sub-Investigator: Carmen Fava, Dr.         
Università degli Studi di Padova - Ematologia ed Immunologia Clinica Not yet recruiting
Padova, Italy
Contact: Pietro Semenzato, Pr.         
Principal Investigator: Pietro Semenzato, Pr.         
Sub-Investigator: Gianni Binotto, Dr.         
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone" Not yet recruiting
Palermo, Italy
Contact: Clementina Caracciolo, Dr.         
Principal Investigator: Clementina Caracciolo, Dr.         
Sub-Investigator: Rosario Di, Maggio         
La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello Not yet recruiting
Palermo, Italy
Contact: Maurizio Musso, Pr.         
Principal Investigator: Maurizio Musto, Pr.         
Sub-Investigator: Ferdinando Pozzetto, Dr.         
Ospedali Riuniti "Villa Sofia-Cervello" Not yet recruiting
Palermo, Italy
Contact: Diamante Turri, Dr.         
Principal Investigator: Diamante Turri, Dr.         
Sub-Investigator: Raimondo Di Bella, Dr.         
Cattedra di Ematologia CTMO Università degli Studi di Parma Recruiting
Parma, Italy
Contact: Franca Aversa, Dr.         
Principal Investigator: Franca Aversa, Dr.         
Sub-Investigator: Monica Crugnola, Dr.         
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore Not yet recruiting
Pesaro, Italy
Contact: Giuseppe Visani, Pr.         
Principal Investigator: Giuseppe Visani, Pr.         
Sub-Investigator: Sara Barulli, Dr.         
U.O. Ematologia Clinica - Azienda USL di Pescara Not yet recruiting
Pescara, Italy
Contact: Roberto Di Lorenzo, Dr.         
Principal Investigator: Roberto Di Lorenzo, Dr.         
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza Not yet recruiting
Piacenza, Italy
Contact: Daniele Vallisa, Dr.         
Principal Investigator: Daniele Vallisa, Dr.         
Sub-Investigator: Elena Trabacchi, Dr.         
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia Not yet recruiting
Pisa, Italy
Contact: Sara Galimberti, Dr.         
Principal Investigator: Sara Galimberti, Dr.         
Sub-Investigator: Claudia Baratè, Dr.         
Dipartimento Oncologico - Ospedale S.Maria delle Croci Not yet recruiting
Ravenna, Italy
Contact: Marzia Salvucci, Dr.         
Principal Investigator: Marzia Salvucci, Dr.         
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" Not yet recruiting
Reggio Calabria, Italy
Contact: Francesco Nobile, Dr.         
Principal Investigator: Francesco Nobile, Dr.         
Sub-Investigator: Bruno Martino, Dr.         
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova Not yet recruiting
Reggio Emilia, Italy
Contact: Paolo Avanzini, Dr.         
Sub-Investigator: Isabella Capodanno, Dr.         
Principal Investigator: Paolo Avanzini, Dr.         
Ospedale "Infermi" Not yet recruiting
Rimini, Italy
Contact: Patrizia Tosi, Dr.         
Principal Investigator: Patrizia Tosi, Dr.         
Sub-Investigator: Anna Lia Molinari, Dr.         
U.O. di Ematologia - Centro Oncologico Basilicata Not yet recruiting
Rionero in Vulture, Italy
Contact: Pellegrino Musto, Dr.         
Principal Investigator: Pellegrino Musto, Dr.         
Sub-Investigator: Giuseppe Pietrantuono, Dr.         
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia Not yet recruiting
Roma, Italy
Contact: Enrico Montefusco, Dr.         
Principal Investigator: Enrico Montefusco, Dr.         
Sub-Investigator: Raffaele Porrini, Dr.         
Complesso Ospedaliero S. Giovanni Addolorata Not yet recruiting
Roma, Italy
Contact: Michele Cedrone, Dr.         
Sub-Investigator: Barbara Anaclerico, Dr.         
Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza" Not yet recruiting
Roma, Italy
Contact: Giuliana Alimena, Pr.         
Principal Investigator: Giuliana Alimena, Pr.         
Sub-Investigator: Massimo Breccia, Dr.         
Segreteria di Ematologia - S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena Not yet recruiting
Roma, Italy
Contact: Atelda Romano, Dr.         
Principal Investigator: Atelda Romano, Dr.         
Sub-Investigator: Azzurra Romero, Dr.         
U.O.C. Ematologia - Ospedale S.Eugenio Not yet recruiting
Roma, Italy
Contact: Elisabetta Abruzzese, Dr.         
Principal Investigator: Elisabetta Abruzzese, Dr.         
Sub-Investigator: Monika Trawinska, Dr.         
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Not yet recruiting
Roma, Italy
Contact: Simona Sica, Dr.         
Principal Investigator: Simona Sica, Dr.         
Sub-Investigator: Federica Sorà, Dr.         
Azienda Sanitaria Locale Viterbo - Polo Ospedaliero Centrale - Ospedale Di Ronciglione - U.O. di Ematologia Not yet recruiting
Ronciglione, Italy
Contact: Marco Montanaro, Dr.         
Principal Investigator: Marco Montanaro, Dr.         
Sub-Investigator: Francesca Celesti, Dr.         
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
S. G. Rotondo, Italy
Contact: Nicola Cascavilla, Pr.         
Sub-Investigator: Nicola Cascavilla, Pr.         
Sub-Investigator: Antonietta Pia, Dr.         
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte" Not yet recruiting
Siena, Italy
Contact: Monica Bocchia, Pr.         
Principal Investigator: Monica Bocchia, Pr.         
Sub-Investigator: Marzia Defina, Dr.         
SS.C. di Oncoematologia - Dipartimento di Medicina Clinica e Sperimentale - Azienda Ospedaliera - S. Maria Di Terni Not yet recruiting
Terni, Italy
Contact: Anna Marina Liberati, Dr.         
Principal Investigator: Anna Marina Liberati, Dr.         
Sub-Investigator: Debora Luzi, Dr.         
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista Not yet recruiting
Torino, Italy
Contact: Patrizia Pregno, Dr.         
Principal Investigator: Patrizia Pregno, Dr.         
Sezione di Ematologia - Med.II Div. Presidio Ospedaliero S. Chiara di Trento Not yet recruiting
Trento, Italy
Contact: Paolo Vivaldi, Dr.         
Principal Investigator: Paolo Vivaldi, Dr.         
Sub-Investigator: Anna Guella, Dr.         
Azienda U.L.S.S.9 - U.O. di Ematologia Recruiting
Treviso, Italy
Contact: Filippo Gherlinzoni, Dr.         
Principal Investigator: Filippo Gherlinzoni, Dr.         
Principal Investigator: Elisabetta Calistri, Dr.         
Clinica Ematologica - Policlinico Universitario Recruiting
Udine, Italy
Contact: Mario Tiribelli, Dr.         
Principal Investigator: Mario Tiribelli, Dr.         
Sub-Investigator: Luciana Marin, Dr.         
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi Not yet recruiting
Verona, Italy
Contact: Giovanni Pizzolo, Pr.         
Principal Investigator: Giovanni Pizzolo, Pr.         
Sub-Investigator: Massimiliano Bonifacio, Dr.         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Gianantonio Rosti, Pr. Department of Hematology and Oncological Sciences, S.Orsola-Malpighi Hospital, University of Bologna
  More Information

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01699217     History of Changes
Other Study ID Numbers: CML0912
First Submitted: October 1, 2012
First Posted: October 3, 2012
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Chronic Myeloid Leukaemia
Philadelphia positive
BCR-ABL positive

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases