Clinical trial NCT01743989: A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.
Official title: A Prospective, Randomized, Open Label, Two Arm Phase III Study to Evaluate Treatment Free Remission (TFR) Rate in Patients With Philadelphia-positive CML After Two Different Durations of Consolidation Treatment With Nilotinib 300mg BID.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Keywords: Adult
Chronic myelogenous leukemia (CML)
Chronic myeloid leukemia (CML)
Chronic myelocytic leukemia (CML)
Acute Lymphoblastic Leukemia (ALL) Philadelphia chromosome positive
Acute Lymphoid Leukemia
Suboptimal molecular response
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants received 24 months of study treatment. After 24 months of treatment, eligible participants (i.e. those deemed to have achieved sustained molecular response) were randomized to one of the two study arms on a continued open-label basis.

Participants not achieving sustained molecular response after 24 months of treatment were not randomized but remained in the study until the 5-year study period was completed (Not randomized arm).
Primary purpose: TREATMENT

Brief summary: This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase.

Detailed description: This was a prospective, randomized, open-label, multicenter Phase III study. The study design was made up of 3 phases:

* Nilotinib induction phase: 12 months
* Nilotinib consolidation phase: 12 or 24 months, depending on randomization
* Nilotinib treatment-free remission (TFR) phase: 24 or 36 months, depending on randomization.

Subjects were enrolled into the study and were treated with nilotinib 300mg twice daily (BID) for 24 months, during the induction (12 months) and consolidation (12 months) phases. At the end of the first 24 months of treatment, participants achieving a sustained molecular response (defined as ≥ MR4.0, in 4 out of 5 real-time quantitative polymerase chain reaction (RQ-PCR) assessments, including the last assessment, in the last 12 months) were randomized on a 1:1 basis to either:

1. suspend nilotinib treatment immediately and enter the TFR phase for 36 months (Nilotinib 24-month treatment arm), or
2. continue nilotinib treatment for a further 12 months (post-randomization consolidation phase), then suspend treatment and enter the TFR phase for 24 months (Nilotinib 36-month treatment arm).

Participants not achieving a sustained molecular response at 24 months from treatment start were not eligible for randomization and were treated at the discretion of the investigator according to standard practice. Information on survival, stem cell transplantation, and status of the patient's disease was collected until death or until 5 years from study entry, whichever came first. Additionally, for Nilotinib 36-month treatment arm, participants who did not achieve a sustained molecular response at 36 months from treatment start, discontinued from the study and were treated according to standard practice and followed up until death or until 5 years from study entry, whichever came first.

Participants relapsing during the TFR phase entered the nilotinib re-treatment phase of the study, and were re-treated with the same dose of nilotinib as they were on before the TFR phase. These patients remained on study until the completion of the 5-year study period unless prematurely withdrawn and discontinued from the study for any reason specified in the Protocol.

Eligibility criteria: Key Inclusion Criteria:

* Confirmed diagnosis of chronic phase Ph+ CML
* Previous first-line treatment with imatinib for a minimum of 2 years;
* Patient in complete cytogenetic response;

Key Exclusion Criteria:

* Previous achievement of MR4.0 at study entry;
* Previous treatment with other target cells inhibitors other than imatinib;
* Patients with any history of detectable atypical Leukemia transcripts or patients with detectable atypical leukemia transcripts at screening;
* Previous anticancer agents for Chronic myeloid leukemia other than imatinib except for cytoreduction;
* Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol;
* History of other active malignancies within the 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively;
* Patients who have not recovered from prior surgery;
* Treatment with other investigational agents within 4 weeks of Day 1;
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug

Other inclusion/exclusion criteria might apply.

Primary outcomes:
measure: Percentage of Participants Who Remained in Treatment Free Remission (TFR) Without Molecular Relapse 12 Months After Entering the TFR Phase
timeFrame: 12 months after entering the TFR phase, which is after 36 months from study treatment start for Nilotinib 24-month treatment arm and after 48 months from study treatment start for Nilotinib 36-month treatment arm
Secondary outcomes:
measure: Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry
timeFrame: From baseline up to 24 months after study treatment start
measure: Cumulative Incidence of MMR During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry
timeFrame: From randomization (month 24 after study treatment start) up to 36 months after study treatment start
measure: Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry
timeFrame: From baseline up to 24 months after study treatment start
measure: Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry
timeFrame: From randomization (month 24 after study treatment start) up to 36 months after study treatment start
measure: Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry
timeFrame: From baseline up to 24 months after study treatment start
measure: Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry
timeFrame: From randomization (month 24 after study treatment start) up to 36 months after study treatment start
measure: Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase
timeFrame: From baseline up to 24 months after study treatment start
measure: Cumulative Incidence of MMR During the Post-randomization Consolidation Phase
timeFrame: From randomization (month 24 after study treatment start) up to 36 months after study treatment start
measure: Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase
timeFrame: From baseline up to 24 months after study treatment start
measure: Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase
timeFrame: From randomization (month 24 after study treatment start) up to 36 months after study treatment start
measure: Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase
timeFrame: From baseline up to 24 months after study treatment start
measure: Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase
timeFrame: From randomization (month 24 after study treatment start) up to 36 months after study treatment start
measure: Percentage of Participants Who Were in MMR During TFR Phase
timeFrame: From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm
measure: Percentage of Participants Who Were in MR4.0 During the TFR Phase
timeFrame: From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotininb 36-months treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-months treatment arm
measure: Percentage of Participants Who Were in MR4.5 During the TFR Phase
timeFrame: From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotininb 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm
measure: BCR-ABL Ratio (Expressed as a Percentage) During the Induction/Consolidation Phase
timeFrame: From baseline up to 24 months after study treatment start for Nilotinib 24-month treatment arm and Not randomized participants; and up to 36 months after study treatment start for Nilotinib 36-month treatment arm.
measure: BCR-ABL Ratio (Expressed as a Percentage) During the TFR Phase
timeFrame: From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm
measure: BCR-ABL Ratio (Expressed as a Percentage) During the Nilotinib Re-treatment Phase
timeFrame: From Day 1 after entering the re-treatment phase up to 24 months after entering re-treatment phase for Nilotinib 36-month treatment arm and 36 months after entering the re-treatment phase for Nilotinib 24-month treatment arm
measure: Progression-free Survival (PFS) During the TFR Phase of the Study.
timeFrame: From the start of the TFR phase to progression to AP/BC or death up to 24 months after entering TFR phase for Nilotininb 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm
measure: Treatment -Free Survival (TFS) During the TFR Phase of the Study
timeFrame: From the start of the TFR phase to the date of occurrence of treatment-free survival event, up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm
measure: Overall Survival (OS) Rate During the TFR Phase of the Study.
timeFrame: From the start of the TFR phase to death due to any cause, assessed up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Novartis Investigative Site
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city: Linz
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city: Le Mans
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state: Cedex 09
city: Paris Cedex 10
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facility: Novartis Investigative Site
state: Cedex 10
city: Caen
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facility: Novartis Investigative Site
state: Cedex
city: Angers Cedex 1
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facility: Novartis Investigative Site
city: Bordeaux Cedex
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facility: Novartis Investigative Site
city: Bordeaux
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facility: Novartis Investigative Site
city: Chalon sur Saône
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facility: Novartis Investigative Site
city: Chambéry cedex
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city: Clermont Ferrand cedex 1
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city: La Roche sur Yon cedex 9
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city: Lille cedex
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city: Lyon Cedex
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city: Metz
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city: Metz
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city: Mulhouse cedex
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city: Nice Cedex
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city: Paris
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city: Perpignan
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city: Rouen Cedex 1
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city: Saint Priest en Jarez
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city: Toulouse
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city: Mannheim
country: Germany
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state: Baden-Wuerttemberg
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city: Braunschweig
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city: Chemnitz
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city: Dresden
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city: Eisenach
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city: Frankfurt
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city: Georgsmarienhuette
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facility: Novartis Investigative Site
city: Halle
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city: Hamm
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city: Kiel
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city: Koeln
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facility: Novartis Investigative Site
city: Leipzig
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city: Lütten-Klein
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facility: Novartis Investigative Site
city: Magdeburg
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city: Marburg
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city: Muenchen
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city: Muenster
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city: Nuernberg
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facility: Novartis Investigative Site
city: Offenburg
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city: Potsdam
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city: Rostock
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city: Rostock
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city: Schorndorf
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city: Schwäbisch-Hall
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city: Stuttgart
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city: Velbert
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city: Westerstede
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city: Wiesbaden
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city: Wuerzburg
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facility: Novartis Investigative Site
city: Athens
country: Greece
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state: GR
city: Thessaloniki
country: Greece
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state: GR
city: Athens
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state: FI
city: Genova
country: Italy
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state: GE
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country: Italy
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state: Lazio
city: Lecce
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state: LE
city: Livorno
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state: LI
city: Messina
country: Italy
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state: ME
city: Milano
country: Italy
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state: MI
city: Milano
country: Italy
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state: MI
city: Milano
country: Italy
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state: MI
city: Modena
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state: MO
city: Palermo
country: Italy
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state: PA
city: Palermo
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state: PA
city: Padova
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state: PD
city: Pescara
country: Italy
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state: PE
city: Pisa
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state: PI
city: Parma
country: Italy
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state: PR
city: Pavia
country: Italy
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state: PV
city: Potenza
country: Italy
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city: Reggio Calabria
country: Italy
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state: RC
city: Reggio Emilia
country: Italy
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state: RE
city: Roma
country: Italy
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state: RM
city: Roma
country: Italy
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state: RM
city: Roma
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state: SI
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city: Orbassano
country: Italy
facility: Novartis Investigative Site
state: TO
city: Torino
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facility: Novartis Investigative Site
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city: Treviso
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facility: Novartis Investigative Site
state: TV
city: Udine
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facility: Novartis Investigative Site
state: UD
city: Mirano
country: Italy
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city: Venezia
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state: VE
city: Vicenza
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city: Verona
country: Italy
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state: VR
city: Napoli
country: Italy
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city: Novara
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city: Perugia
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facility: Novartis Investigative Site
city: Bergen
country: Norway
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city: Oslo
country: Norway
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city: Chorzow
country: Poland
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city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
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country: Poland
facility: Novartis Investigative Site
city: Olsztyn
country: Poland
facility: Novartis Investigative Site
city: Opole
country: Poland
facility: Novartis Investigative Site
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country: Poland
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city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Bucharest
country: Romania
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state: District 2
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
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country: Romania
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country: Romania
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city: Timisoara
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city: Belgrade
country: Serbia
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city: Belgrade
country: Serbia
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city: Nis
country: Serbia
facility: Novartis Investigative Site
city: Novi Sad
country: Serbia
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city: Bratislava
country: Slovakia
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city: Martin
country: Slovakia
facility: Novartis Investigative Site
city: Ljubljana
country: Slovenia
facility: Novartis Investigative Site
city: Granada
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Jaen
country: Spain
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state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: León
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Salamanca
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Valladolid
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Badalona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Girona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Hospitalet de LLobregat
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Tarragona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Caceres
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Pontevedra
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Palma De Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: Pamplona
country: Spain
facility: Novartis Investigative Site
state: Navarra
city: San Sebastian
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Granollers
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Murcia
country: Spain
facility: Novartis Investigative Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: East Yorkshire
country: United Kingdom
facility: Novartis Investigative Site
city: Edinburgh
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Borghi L, Rosti G, Maggi A, Breccia M, Di Bona E, Iurlo A, La Barba G, Sportoletti P, Albano F, Galimberti S, Rivellini F, Cambrin GR, Capodanno I, Cuneo A, Bonifacio M, Sica S, Arcaini L, Capochiani E, Minotto C, Ciceri F, Crugnola M, Di Caprio L, Supekar S, Elena C, Baccarani M, Vegni E. Perspectives and Emotional Experiences of Patients With Chronic Myeloid Leukemia During ENESTPath Clinical Trial and Treatment-Free Remission: Rationale and Protocol of the Italian Substudy. Front Oncol. 2021 May 26;11:638689. doi: 10.3389/fonc.2021.638689. eCollection 2021.