Chronyc Myeloid LeukemiaPhase 4SUSTRENIMNCT02602314
Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia
A Phase 4 study testing Imatinib and Nilotinib in people with Chronyc Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 82 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronyc Myeloid Leukemia
- What is being tested?
- Imatinib and Nilotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 82 sitesin 2 countries
- Study dates
- 11 Nov 2016to Feb 2024
- Phase
- Phase 4
- 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
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
82 sites in 2 countries.
82 sites in 2 countries
Italy76 sites
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi G. Salesi
Ancona
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
Ascoli Piceno
Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
Asti
Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto
Avellino
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari
Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - Barletta - Uo Ematologia
Barletta
Ematologia Torre 6 piano 4 - ASST Papa Giovanni XXIII
Bergamo
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna
USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
Brescia
ASL N.8 -Ospedale A. Businco
Cagliari
Cagliari CTMO - Ematologia - Ospedale "Binaghi"
Cagliari
Gemelli Molise - Campobasso - Uosd Onco-Ematologia
Campobasso
U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo
Castelfranco Veneto
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania
Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
Catanzaro
U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
Civitanova Marche
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Cona
Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia
Cosenza
S.C. Ematologia ASO S. Croce e Carle
Cuneo
Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
Florence
Aou Ospedali Riuniti - Foggia - Uoc Ematologia
Foggia
Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
Genova
IRCCS_AOU San Martino-IST.Clinica Ematologica
Genova
Asl Latina, Presidio Ospedaliero Nord - Ospedale Santa Maria Goretti - Uoc Ematologia
Latina
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce
I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
Meldola
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. di Ematologia- Ospedale dell'Angelo - Mestre
Mestre
Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
Milan
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan
UO Ematologia - AOU Policlinico di Modena
Modena
Asl Napoli 1 Centro, Presidio Ospedaliero Ascalesi - Ospedale S.Maria Di Loreto Nuovo
Naples
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
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara
U.O. CTMO Ematologia - Osp. S. Francesco
Nuoro
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
Orbassano
Aou Di Padova - Uo Ematologia
Padova
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
Pagani
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo
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"
Palermo
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
Parma
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
Pesaro
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Pescara
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
Piacenza
Az.Ospedaliera S.G.Moscati
Potenza
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
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
Rimini
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
Roma
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma
Divisione Ematologia - Università Campus Bio-Medico
Roma
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
Roma
U.O.C. Ematologia - Ospedale S. Eugenio
Rome
Unità Operativa di Oncologia Giovanni Paolo II "Vito Fazzi"
Rossano
Aulss 5 Polesana, Presidio Ospedaliero Di Rovigo - Uosd Ematologia
Rovigo
Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
Salerno
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Ematologia - Dipartimento di Medicina Clinica e Sperimentale
Sassari
Ospedale Di Sassuolo Spa - Ematologia
Sassuolo
Aou Senese - Uoc Ematologia E Trapianti
Siena
A.O. Santa Maria - Terni S.C Oncoematologia
Terni
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
Torino
Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia
Torino
Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
Treviso
Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine
Udine
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Vicenza
ULSS N.6 Osp. S. Bortolo
Vicenza
Netherlands6 sites
Meander Mc - Paesi Bassi
Amersfoort
Vumc - Paesi Bassi
Amsterdam
Reinier de Graaf Gasthuis
Delft
A. Schweitzer Zh, Dordwijk - Paesi Bassi
Dordrecht
Zuyderland Medical Center - Paesi Bassi
Heerlen
Spaarne Ziekenhuis - Paesi Bassi
Hoofddorp
About this study
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
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.
Read the 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.
- Conditions
- Chronyc Myeloid Leukemia
- Being tested
- Imatinib, Nilotinib
- Keywords
- Chronic myeloid leukemia, Nilotinib, Imatinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
NilotinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Imatinib + Nilotinib | Experimental | Not described Receives: Drug: Imatinib; Drug: Nilotinib |
| Nilotinib | Experimental | Not described Receives: Drug: Nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of of patients with molecular response
Measured: At 24 months from study entry
Number of patients who remain in sustained treatment free remission, without molecular relapse
Measured: After 12 months after entering the treatment-free-remission (TFR) phase
Secondary outcomes (6)
Number of patients with molecular response
Measured: 4 years after study entry
Number of patiens in progression-free survival
Measured: 5 years after study entry
Number of patients with major molecular response
Measured: At 1, 2, 3 and 4 years from study entry
Number of toxic events
Measured: At 5 years from study entry
Number of patients who discontinue treatment
Measured: At 5 years from study entry
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).
Measured: At baseline and at 3, 6, 12, 18, 24, 30, 36, 42, 48, and 60 months 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 posted11 Nov 2015 (estimated)
- Study start11 Nov 2016
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronyc Myeloid LeukemiaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrizio Pane, Study chair, Università Federico II of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602314
- Sponsor's protocol ID
- CML1415
- Acronym
- SUSTRENIM
- Status last verified
- Jan 2022
- First submitted
- 10 Nov 2015
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02602314
- Acronym / sponsor ID
- SUSTRENIM / CML1415
- Conditions
- Chronyc Myeloid Leukemia
- Keywords
- Chronic myeloid leukemia, Nilotinib, Imatinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 11 Nov 2015 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imatinib + Nilotinib | Experimental | Drug: Imatinib, Drug: Nilotinib |
| Nilotinib | Experimental | Drug: Nilotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with a confirmed diagnosis of BCR/ABL+ CML in chronic phase
- < 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
- 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
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imatinib | Drug | Imatinib + Nilotinib |
| Nilotinib | Drug | Imatinib + Nilotinib, Nilotinib |
Primary outcome
Number of of patients with molecular response
Time frame: At 24 months from study entry
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
6 secondary outcomes
Number of patients with molecular response
Time frame: 4 years after study entry
Number of patiens in progression-free survival
Time frame: 5 years after study entry
Number of patients with major molecular response
Time frame: At 1, 2, 3 and 4 years from study entry
Number of toxic events
Time frame: At 5 years from study entry
Number of patients who discontinue treatment
Time frame: At 5 years from study entry
Number of patients with quality of life differences between treatment arms over time
Time frame: At baseline and at 3, 6, 12, 18, 24, 30, 36, 42, 48, and 60 months from study entry.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: No
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.
Fabrizio Pane study chair
Università Federico II of Naples
82 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imatinib and Nilotinib in people with Chronyc Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 82 sites in 2 countries.
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 12 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in Italy, Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Number of of patients with molecular response (time frame: At 24 months from study entry). The study lists 2 primary outcomes in all. 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 20 Jan 2022.