Chronic Phase Philadelphia PositiveCML0912NCT01699217
Front-line Nilotinib Treatment of BCR-ABL+ Chronic Myeloid Leukaemia in Chronic Phase
An observational study of Chronic Phase Philadelphia Positive and BCR-ABL Positive, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 56 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Phase Philadelphia Positive, BCR-ABL Positive, Chronic Myeloid Leukaemia
- How many people
- 129 participants
- Where
- 56 sitesItaly
- Study dates
- 21 Jun 2013to 28 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
Italy56 sites
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Azienda Ospedaliera Nuovo Ospedale "Torrette"
Ancona
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
Ascoli Piceno
Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari
Policlinico Sant'Orsola Malpighi
Bologna
USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
Brescia
Divisione di Ematologia Ospedale A. Perrino
Brindisi
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Cagliari
U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche
Campobasso
US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo
Castelfranco Veneto
ezione di Ematologia C.T.M.O. Istituti Ospitalieri
Cremona
Ospedale Santa Croce Divisione di Ematologia Cuneo
Cuneo
Policlinico di Careggi, Università delgi studi di Firenze
Florence
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
Foggia
Clinica Ematologica - DiMI - Università degli Studi di Genova
Genova
IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
Genova
SOC Ematologia e Centro Trasfusionale Ospedale di Ivrea - ASL TO4
Ivrea
Divisione di Ematologia Ospedale "Santa Maria Goretti"
Latina
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
Messina
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
Milan
UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
Milan
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Naples
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Naples
Ospedale San Gennaro - ASL Napoli 1
Naples
Sez. di Ematologia Clinica Ospedale San Francesco
Nuoro
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2 Prof. Giuseppe Saglio
Orbassano
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Padova
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
Palermo
La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello
Palermo
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
Pesaro
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
Piacenza
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
Pisa
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia
Ospedale "Infermi"
Rimini
U.O. di Ematologia - Centro Oncologico Basilicata
Rionero in Vulture
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma
Complesso Ospedaliero S. Giovanni Addolorata
Roma
Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
Roma
Segreteria di Ematologia - S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
Roma
U.O.C. Ematologia - Ospedale S.Eugenio
Roma
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
Azienda Sanitaria Locale Viterbo - Polo Ospedaliero Centrale - Ospedale Di Ronciglione - U.O. di Ematologia
Ronciglione
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Siena
SS.C. di Oncoematologia - Dipartimento di Medicina Clinica e Sperimentale - Azienda Ospedaliera - S. Maria Di Terni
Terni
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Torino
Sezione di Ematologia - Med.II Div. Presidio Ospedaliero S. Chiara di Trento
Trento
Azienda U.L.S.S.9 - U.O. di Ematologia
Treviso
Clinica Ematologica - Policlinico Universitario
Udine
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona
About this study
Official title: Front-line Nilotinib Treatment of BCR-ABL+ Chronic Myeloid Leukaemia in Chronic Phase. An Observational Multicentre Study of the GIMEMA CML WP.
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.
Read the 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.
- Keywords
- Chronic Myeloid Leukaemia, Philadelphia positive, BCR-ABL positive
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of confirmed MR4
Measured: At 24 months from study entry
Secondary outcomes (10)
The rate of MMR
Measured: At 24, 36, 48, and 60 months from study entry.
The rate of MR4
Measured: At 24, 36, 48, and 60 months from study entry.
The rate of MR4.5
Measured: At 24, 36, 48, and 60 months from study entry.
The rate of confirmed MR4
Measured: At 36, 48, and 60 months from study entry.
The rate of stable MR4
(at least three PCR results with MR4 within the last year [± 2 months] and no results > 0.01% during the same period).
Measured: At 24, 36, 48, and 60 months from study entry
The rate of stable MR4.5
(at least three PCR results with MR4.5 within the last year [± 2 months] and no results > 0.0032% during the same period)
Measured: At 24, 36, 48, and 60 months from study entry
The rate of confirmed loss of MMR (MR3)
Measured: At 60 months from study entry
The rate of confirmed loss of MMR
Measured: At one year from study entry
The rate of Complete Cytogenetic Response
Measured: At one year.
The cumulative rate of permanent NIL discontinuation
(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)
Measured: At 5 years from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study start21 Jun 2013
- Primary completion16 Dec 2017
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Phase Philadelphia PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianantonio Rosti, Pr., Principal investigator, Department of Hematology and Oncological Sciences, S.Orsola-Malpighi Hospital, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699217
- Sponsor's protocol ID
- CML0912
- Acronym
- CML0912
- Status last verified
- Apr 2025
- First submitted
- 1 Oct 2012
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Front-line Nilotinib Treatment of BCR-ABL+ Chronic Myeloid Leukaemia in Chronic Phase. An Observational Multicentre Study of the GIMEMA CML WP.
- ClinicalTrials.gov ID
- NCT01699217
- Acronym / sponsor ID
- CML0912 / CML0912
- Keywords
- Chronic Myeloid Leukaemia, Philadelphia positive, BCR-ABL positive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 21 Jun 2013 (actual)
- Primary completion
- 16 Dec 2017 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of confirmed MR4
Time frame: At 24 months from study entry
10 secondary outcomes
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
The rate of stable MR4.5
Time frame: At 24, 36, 48, and 60 months from study entry
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Phase Philadelphia Positive
Not yet recruitingPhase 1/2
Phase 1/2 FLAG-IDA, VEN and Asciminib in CML and Ph+ AML
Myeloid Leukemia
Not yet recruitingPhase 3
A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIs
Chronic Myeloid Leukemia (CML), Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
Not yet recruitingPhase 3
A Study of HS-10382 Versus Investigator-selected TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
Chronic Myeloid Leukemia
RecruitingPhase 2
Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive
RecruitingObservational study
A Study on the Tolerability, Safety and Effectiveness of Asciminib in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase in Germany
Leukemia, Chronic Myeloid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianantonio Rosti, Pr. principal investigator
Department of Hematology and Oncological Sciences, S.Orsola-Malpighi Hospital, University of Bologna
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Phase Philadelphia Positive and BCR-ABL Positive, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 56 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of confirmed MR4 (time frame: At 24 months from study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.