Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia
NCT ID: NCT02602314
Last Updated: 2022-01-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
450 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-11-11
Study Completion Date
2024-02-29
Brief Summary
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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.
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Detailed Description
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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.
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
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Chronyc Myeloid Leukemia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Imatinib + Nilotinib
Group Type
EXPERIMENTAL
Imatinib
Intervention Type
DRUG
Nilotinib
Intervention Type
DRUG
Nilotinib
Group Type
EXPERIMENTAL
Nilotinib
Intervention Type
DRUG
Interventions
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Imatinib
Intervention Type
DRUG
Nilotinib
Intervention Type
DRUG
Eligibility Criteria
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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.
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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Fabrizio Pane
Role: STUDY_CHAIR
Università Federico II of Naples
Locations
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S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Site Status
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi G. Salesi
Ancona, , Italy
Site Status
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
Ascoli Piceno, , Italy
Site Status
Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
Asti, , Italy
Site Status
Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto
Avellino, , Italy
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Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, , Italy
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UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari, , Italy
Site Status
Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - Barletta - Uo Ematologia
Barletta, , Italy
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Ematologia Torre 6 piano 4 - ASST Papa Giovanni XXIII
Bergamo, , Italy
Site Status
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, , Italy
Site Status
USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia
Brescia, , Italy
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ASL N.8 -Ospedale A. Businco
Cagliari, , Italy
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Cagliari CTMO - Ematologia - Ospedale "Binaghi"
Cagliari, , Italy
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Gemelli Molise - Campobasso - Uosd Onco-Ematologia
Campobasso, , Italy
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U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo
Castelfranco Veneto, , Italy
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Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, , Italy
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Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
Catanzaro, , Italy
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U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
Civitanova Marche, , Italy
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Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Cona, , Italy
Site Status
Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia
Cosenza, , Italy
Site Status
S.C. Ematologia ASO S. Croce e Carle
Cuneo, , Italy
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Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano
Florence, , Italy
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Aou Ospedali Riuniti - Foggia - Uoc Ematologia
Foggia, , Italy
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Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
Genova, , Italy
Site Status
IRCCS_AOU San Martino-IST.Clinica Ematologica
Genova, , Italy
Site Status
Asl Latina, Presidio Ospedaliero Nord - Ospedale Santa Maria Goretti - Uoc Ematologia
Latina, , Italy
Site Status
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce, , Italy
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I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
Meldola, , Italy
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Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
Messina, , Italy
Site Status
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina, , Italy
Site Status
U.O. di Ematologia- Ospedale dell'Angelo - Mestre
Mestre, , Italy
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Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
Milan, , Italy
Site Status
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan, , Italy
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UO Ematologia - AOU Policlinico di Modena
Modena, , Italy
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Asl Napoli 1 Centro, Presidio Ospedaliero Ascalesi - Ospedale S.Maria Di Loreto Nuovo
Napoli, , Italy
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Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
Napoli, , Italy
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Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, , Italy
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Ospedale San Gennaro - ASL Napoli 1
Napoli, , Italy
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S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara, , Italy
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U.O. CTMO Ematologia - Osp. S. Francesco
Nuoro, , Italy
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Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
Orbassano, , Italy
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Aou Di Padova - Uo Ematologia
Padua, , Italy
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Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
Pagani, , Italy
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Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, , Italy
Site Status
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, , Italy
Site Status
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
Parma, , Italy
Site Status
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
Pesaro, , Italy
Site Status
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Pescara, , Italy
Site Status
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
Piacenza, , Italy
Site Status
Az.Ospedaliera S.G.Moscati
Potenza, , Italy
Site Status
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna, , Italy
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Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, , Italy
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Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
Site Status
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
Rimini, , Italy
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Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
Roma, , Italy
Site Status
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma, , Italy
Site Status
Divisione Ematologia - Università Campus Bio-Medico
Roma, , Italy
Site Status
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, , Italy
Site Status
UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
Roma, , Italy
Site Status
U.O.C. Ematologia - Ospedale S. Eugenio
Rome, , Italy
Site Status
Unità Operativa di Oncologia Giovanni Paolo II "Vito Fazzi"
Rossano, , Italy
Site Status
Aulss 5 Polesana, Presidio Ospedaliero Di Rovigo - Uosd Ematologia
Rovigo, , Italy
Site Status
Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
Salerno, , Italy
Site Status
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Site Status
Ematologia - Dipartimento di Medicina Clinica e Sperimentale
Sassari, , Italy
Site Status
Ospedale Di Sassuolo Spa - Ematologia
Sassuolo, , Italy
Site Status
Aou Senese - Uoc Ematologia E Trapianti
Siena, , Italy
Site Status
A.O. Santa Maria - Terni S.C Oncoematologia
Terni, , Italy
Site Status
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino, , Italy
Site Status
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
Torino, , Italy
Site Status
Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia
Torino, , Italy
Site Status
Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
Treviso, , Italy
Site Status
Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine
Udine, , Italy
Site Status
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona, , Italy
Site Status
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Vicenza, , Italy
Site Status
ULSS N.6 Osp. S. Bortolo
Vicenza, , Italy
Site Status
Meander Mc - Paesi Bassi
Amersfoort, , Netherlands
Site Status
Vumc - Paesi Bassi
Amsterdam, , Netherlands
Site Status
Reinier de Graaf Gasthuis
Delft, , Netherlands
Site Status
A. Schweitzer Zh, Dordwijk - Paesi Bassi
Dordrecht, , Netherlands
Site Status
Zuyderland Medical Center - Paesi Bassi
Heerlen, , Netherlands
Site Status
Spaarne Ziekenhuis - Paesi Bassi
Hoofddorp, , Netherlands
Site Status
Countries
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Italy
Netherlands
Other Identifiers
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CML1415
Identifier Type: -
Identifier Source: org_study_id
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RECRUITING
NA
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ACTIVE_NOT_RECRUITING
PHASE1
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COMPLETED
PHASE2