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A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML. (ENESTPath)

Primary Purpose

Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nilotinib

About this trial

This is an interventional treatment trial for Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Nilotinib 24-month treatment

Nilotinib 36-month treatment

Not randomized

Arm Description

Participants were treated with nilotinib 300mg BID for 24 months and, thereafter, entered the 36-month TFR phase

Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase

Participants were treated with nolotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Remained in Treatment Free Remission (TFR) Without Molecular Relapse 12 Months After Entering the TFR Phase

Number of participants who remained in TFR (≥molecular response (MR) 4.0) without molecular relapse 12 months after entering the TFR phase (without re-starting nilotinib therapy) divided by the number of participants who entered the TFR phase and multiplied by 100. Molecular relapse during TFR is defined as the loss of major molecular response (MMR), or the confirmed loss of MR4.0 (defined by 3 consecutive tests less than MR4.0 assessed at 3 consecutive visits during TFR phase). Participants dropping out early from the study during the TFR phase were considered as unsuccessful TFR. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL. MR4.0 is defined as either detectable disease≤0.01% BCR-ABL or undetectable disease in cDNA with≥10,000 ABL transcripts

Secondary Outcome Measures

Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry

Number of participants who were in MMR during pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL.

Cumulative Incidence of MMR During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry

Number of participants who were in MMR during post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL.

Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry

Number of participants who were in MR4.0 during the pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)

Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry

Number of participants who were in MR4.0 during the post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)

Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry

Number of participants who were in MR4.5 during the pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)

Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry

Number of participants who were in MR4.5 during the post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)

Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase

Number of participants who were in MMR during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL.

Cumulative Incidence of MMR During the Post-randomization Consolidation Phase

Number of participants who were in MMR during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL.

Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase

Number of participants who were in MR4.0 during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)

Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase

Number of participants who were in MR4.0 during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)

Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase

Number of participants who were in MR4.5 during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)

Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase

Number of participants who were in MR4.5 during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)

Percentage of Participants Who Were in MMR During TFR Phase

Number of participants who were in MMR at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL.

Percentage of Participants Who Were in MR4.0 During the TFR Phase

Number of participants who were in MR4.0 at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)

Percentage of Participants Who Were in MR4.5 During the TFR Phase

Number of participants who were in MR4.5 at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. Confidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)

BCR-ABL Ratio (Expressed as a Percentage) During the Induction/Consolidation Phase

BCR-ABL transcript ratio by international scale (IS) (expressed as a percentage) during the induction/consolidation phase. Participants randomized to Nilotinib 36-month treatment arm had 12-month additional consolidation phase (post-randomization).

BCR-ABL Ratio (Expressed as a Percentage) During the TFR Phase

BCR-ABL/control gene (ABL) transcript ratio by international scale (IS) (expressed as a percentage) during the TFR phase. BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase.

BCR-ABL Ratio (Expressed as a Percentage) During the Nilotinib Re-treatment Phase

BCR-ABL/control gene (ABL) transcript ratio by international scale (IS) (expressed as a percentage) during the nilotinib re-treatment phase. BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes.

Progression-free Survival (PFS) During the TFR Phase of the Study.

PFS is defined as the time from the date of start of the nilotinib TFR phase to the date of acelerated phase/blast crisis (AP/BC) or death, whichever came first. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotini 24-month treatment arm had a maximum of 36 months of TFR phase. Patients not known to have recurred or died on or before the cut-off date for PFS analysis were censored at the date of their last assessment (cytogenetic, hematology or extramedullary) for patients who were on study, and at the date of last contact for patients who were in follow-up.

Treatment -Free Survival (TFS) During the TFR Phase of the Study

TFS is defined as the time from the start of the TFR phase to the date of the earliest of the following: loss of MMR, confirmed loss of MR4.0,re-start of nilotinib treatment, progression to AP/BC, or death from any cause. Patients not known to have had any of the events on or before the cut-off date were censored at the earlier of the date of their last assessment for patients who were still on study and the date of last contact for patients who were in follow-up. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1%BCR-ABL. MR4.0 is defined as either detectable disease ≤0.01%BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)

Overall Survival (OS) Rate During the TFR Phase of the Study.

OS is defined as the time from start of the TFR phase to the time of death due to any cause. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotini 24-month treatment arm had a maximum of 36 months of TFR phase. For participants without any event on or before the cut-off date, survival time will be censored at the date of their last assessment for patients who are still on study, and at the date of last contact for patients who are in follow-up.

Full Information

NCT ID

NCT01743989

First Posted

December 4, 2012

Last Updated

June 23, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01743989

Brief Title

A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.

Acronym

ENESTPath

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

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

April 15, 2013 (Actual)

Primary Completion Date

July 8, 2020 (Actual)

Study Completion Date

July 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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: suspend nilotinib treatment immediately and enter the TFR phase for 36 months (Nilotinib 24-month treatment arm), or 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

620 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nilotinib 24-month treatment

Arm Type

Experimental

Arm Description

Participants were treated with nilotinib 300mg BID for 24 months and, thereafter, entered the 36-month TFR phase

Arm Title

Nilotinib 36-month treatment

Arm Type

Experimental

Arm Description

Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase

Arm Title

Not randomized

Arm Type

Experimental

Arm Description

Participants were treated with nolotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment.

Intervention Type

Drug

Intervention Name(s)

Nilotinib

Other Intervention Name(s)

AMN107

Intervention Description

Participants received a daily oral nilotinib dose of 300 mg BID, given as two 150 mg capsules BID.

Primary Outcome Measure Information:

Title

Percentage of Participants Who Remained in Treatment Free Remission (TFR) Without Molecular Relapse 12 Months After Entering the TFR Phase

Description

Time Frame

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 Outcome Measure Information:

Title

Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry

Description

Time Frame

From baseline up to 24 months after study treatment start

Title

Cumulative Incidence of MMR During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry

Description

Time Frame

From randomization (month 24 after study treatment start) up to 36 months after study treatment start

Title

Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry

Description

Time Frame

From baseline up to 24 months after study treatment start

Title

Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry

Description

Time Frame

From randomization (month 24 after study treatment start) up to 36 months after study treatment start

Title

Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry

Description

Time Frame

From baseline up to 24 months after study treatment start

Title

Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry

Description

Time Frame

From randomization (month 24 after study treatment start) up to 36 months after study treatment start

Title

Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase

Description

Time Frame

From baseline up to 24 months after study treatment start

Title

Cumulative Incidence of MMR During the Post-randomization Consolidation Phase

Description

Time Frame

From randomization (month 24 after study treatment start) up to 36 months after study treatment start

Title

Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase

Description

Time Frame

From baseline up to 24 months after study treatment start

Title

Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase

Description

Time Frame

From randomization (month 24 after study treatment start) up to 36 months after study treatment start

Title

Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase

Description

Time Frame

From baseline up to 24 months after study treatment start

Title

Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase

Description

Time Frame

From randomization (month 24 after study treatment start) up to 36 months after study treatment start

Title

Percentage of Participants Who Were in MMR During TFR Phase

Description

Time Frame

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

Title

Percentage of Participants Who Were in MR4.0 During the TFR Phase

Description

Time Frame

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

Title

Percentage of Participants Who Were in MR4.5 During the TFR Phase

Description

Time Frame

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

Title

BCR-ABL Ratio (Expressed as a Percentage) During the Induction/Consolidation Phase

Description

Time Frame

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.

Title

BCR-ABL Ratio (Expressed as a Percentage) During the TFR Phase

Description

Time Frame

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

Title

BCR-ABL Ratio (Expressed as a Percentage) During the Nilotinib Re-treatment Phase

Description

Time Frame

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

Title

Progression-free Survival (PFS) During the TFR Phase of the Study.

Description

Time Frame

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

Title

Treatment -Free Survival (TFS) During the TFR Phase of the Study

Description

Time Frame

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

Title

Overall Survival (OS) Rate During the TFR Phase of the Study.

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Linz

State/Province

Oberoesterreich

ZIP/Postal Code

A 4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

A-4010

Country

Austria

Facility Name

Novartis Investigative Site

City

Rankweil

ZIP/Postal Code

A-6830

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Brno Bohunice

State/Province

Czech Republic

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Hradec Kralove

State/Province

CZE

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Novartis Investigative Site

City

Holstebro

ZIP/Postal Code

DK-7500

Country

Denmark

Facility Name

Novartis Investigative Site

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Facility Name

Novartis Investigative Site

City

HUS Helsinki

ZIP/Postal Code

FIN-00029

Country

Finland

Facility Name

Novartis Investigative Site

City

Bayonne

State/Province

Bayonne Cedex

ZIP/Postal Code

64109

Country

France

Facility Name

Novartis Investigative Site

City

Le Mans

State/Province

Cedex 09

ZIP/Postal Code

72037

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 10

State/Province

Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Novartis Investigative Site

City

Caen

State/Province

Cedex

ZIP/Postal Code

14033

Country

France

Facility Name

Novartis Investigative Site

City

Angers Cedex 1

ZIP/Postal Code

49033

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux Cedex

ZIP/Postal Code

33000

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Novartis Investigative Site

City

Chalon sur Saône

ZIP/Postal Code

71321

Country

France

Facility Name

Novartis Investigative Site

City

Chambéry cedex

ZIP/Postal Code

73011

Country

France

Facility Name

Novartis Investigative Site

City

Clermont Ferrand cedex 1

ZIP/Postal Code

63003

Country

France

Facility Name

Novartis Investigative Site

City

Corbeil Essonnes

ZIP/Postal Code

91100

Country

France

Facility Name

Novartis Investigative Site

City

Dunkerque

ZIP/Postal Code

59240

Country

France

Facility Name

Novartis Investigative Site

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

La Roche sur Yon cedex 9

ZIP/Postal Code

85925

Country

France

Facility Name

Novartis Investigative Site

City

Lille cedex

ZIP/Postal Code

59020

Country

France

Facility Name

Novartis Investigative Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Lyon Cedex

ZIP/Postal Code

69373

Country

France

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

Novartis Investigative Site

City

Metz

ZIP/Postal Code

57000

Country

France

Facility Name

Novartis Investigative Site

City

Metz

ZIP/Postal Code

57085

Country

France

Facility Name

Novartis Investigative Site

City

Mulhouse cedex

ZIP/Postal Code

68070

Country

France

Facility Name

Novartis Investigative Site

City

Nice Cedex

ZIP/Postal Code

06202

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Novartis Investigative Site

City

Perpignan

ZIP/Postal Code

66046

Country

France

Facility Name

Novartis Investigative Site

City

Pontoise

ZIP/Postal Code

F-95300

Country

France

Facility Name

Novartis Investigative Site

City

Rouen Cedex 1

ZIP/Postal Code

76038

Country

France

Facility Name

Novartis Investigative Site

City

Saint Priest en Jarez

ZIP/Postal Code

42271

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68305

Country

Germany

Facility Name

Novartis Investigative Site

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Braunschweig

ZIP/Postal Code

38114

Country

Germany

Facility Name

Novartis Investigative Site

City

Bremen

ZIP/Postal Code

28177

Country

Germany

Facility Name

Novartis Investigative Site

City

Chemnitz

ZIP/Postal Code

09113

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Eisenach

ZIP/Postal Code

99817

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Georgsmarienhuette

ZIP/Postal Code

49124

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

ZIP/Postal Code

06110

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamm

ZIP/Postal Code

59063

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

50671

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Lütten-Klein

ZIP/Postal Code

18107

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39104

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81241

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuernberg

ZIP/Postal Code

90449

Country

Germany

Facility Name

Novartis Investigative Site

City

Offenburg

ZIP/Postal Code

77654

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14467

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18059

Country

Germany

Facility Name

Novartis Investigative Site

City

Schorndorf

ZIP/Postal Code

73614

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwäbisch-Hall

ZIP/Postal Code

74523

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70174

Country

Germany

Facility Name

Novartis Investigative Site

City

Velbert

ZIP/Postal Code

42551

Country

Germany

Facility Name

Novartis Investigative Site

City

Westerstede

ZIP/Postal Code

26655

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

106 76

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Patras

ZIP/Postal Code

265 00

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

H 6725

Country

Hungary

Facility Name

Novartis Investigative Site

City

Alessandria

State/Province

ZIP/Postal Code

15100

Country

Italy

Facility Name

Novartis Investigative Site

City

Ancona

State/Province

ZIP/Postal Code

60126

Country

Italy

Facility Name

Novartis Investigative Site

City

Avellino

State/Province

ZIP/Postal Code

83100

Country

Italy

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70124

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Facility Name

Novartis Investigative Site

City

Cagliari

State/Province

ZIP/Postal Code

09126

Country

Italy

Facility Name

Novartis Investigative Site

City

Cremona

State/Province

ZIP/Postal Code

26100

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95100

Country

Italy

Facility Name

Novartis Investigative Site

City

Cona

State/Province

ZIP/Postal Code

44100

Country

Italy

Facility Name

Novartis Investigative Site

City

San Giovanni Rotondo

State/Province

ZIP/Postal Code

71013

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Lecce

State/Province

ZIP/Postal Code

73100

Country

Italy

Facility Name

Novartis Investigative Site

City

Livorno

State/Province

ZIP/Postal Code

57124

Country

Italy

Facility Name

Novartis Investigative Site

City

Messina

State/Province

ZIP/Postal Code

98125

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20162

Country

Italy

Facility Name

Novartis Investigative Site

City

Modena

State/Province

ZIP/Postal Code

41124

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90127

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90146

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Pescara

State/Province

ZIP/Postal Code

65124

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56126

Country

Italy

Facility Name

Novartis Investigative Site

City

Parma

State/Province

ZIP/Postal Code

43100

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Potenza

State/Province

ZIP/Postal Code

85100

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Calabria

State/Province

ZIP/Postal Code

89124

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Emilia

State/Province

ZIP/Postal Code

42123

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00144

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Pagani

State/Province

ZIP/Postal Code

84016

Country

Italy

Facility Name

Novartis Investigative Site

City

Siena

State/Province

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novartis Investigative Site

City

Taranto

State/Province

ZIP/Postal Code

74100

Country

Italy

Facility Name

Novartis Investigative Site

City

Orbassano

State/Province

ZIP/Postal Code

10043

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Treviso

State/Province

ZIP/Postal Code

31100

Country

Italy

Facility Name

Novartis Investigative Site

City

Udine

State/Province

ZIP/Postal Code

33100

Country

Italy

Facility Name

Novartis Investigative Site

City

Mirano

State/Province

ZIP/Postal Code

30035

Country

Italy

Facility Name

Novartis Investigative Site

City

Venezia

State/Province

ZIP/Postal Code

30174

Country

Italy

Facility Name

Novartis Investigative Site

City

Vicenza

State/Province

ZIP/Postal Code

36100

Country

Italy

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37126

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Novartis Investigative Site

City

Perugia

ZIP/Postal Code

06129

Country

Italy

Facility Name

Novartis Investigative Site

City

Bergen

ZIP/Postal Code

NO-5021

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

NO-0310

Country

Norway

Facility Name

Novartis Investigative Site

City

Chorzow

ZIP/Postal Code

41-500

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80 952

Country

Poland

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40-027

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Novartis Investigative Site

City

Olsztyn

ZIP/Postal Code

10 561

Country

Poland

Facility Name

Novartis Investigative Site

City

Opole

ZIP/Postal Code

45-372

Country

Poland

Facility Name

Novartis Investigative Site

City

Torun

ZIP/Postal Code

87 100

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02 106

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02 776

Country

Poland

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1099 023

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1749-035

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200 319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 2

ZIP/Postal Code

022328

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

030 171

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

500098

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj-Napoca

ZIP/Postal Code

400124

Country

Romania

Facility Name

Novartis Investigative Site

City

Iasi

ZIP/Postal Code

700483

Country

Romania

Facility Name

Novartis Investigative Site

City

Sibiu

ZIP/Postal Code

550245

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

ZIP/Postal Code

300 079

Country

Romania

Facility Name

Novartis Investigative Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Belgrade

ZIP/Postal Code

11070

Country

Serbia

Facility Name

Novartis Investigative Site

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Novi Sad

Country

Serbia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

85107

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

03601

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Granada

State/Province

Andalucia

ZIP/Postal Code

18014

Country

Spain

Facility Name

Novartis Investigative Site

City

Jaen

State/Province

Andalucia

ZIP/Postal Code

23007

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novartis Investigative Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Novartis Investigative Site

City

León

State/Province

Castilla Y Leon

ZIP/Postal Code

24071

Country

Spain

Facility Name

Novartis Investigative Site

City

Salamanca

State/Province

Castilla Y Leon

ZIP/Postal Code

37007

Country

Spain

Facility Name

Novartis Investigative Site

City

Valladolid

State/Province

Castilla Y Leon

ZIP/Postal Code

47011

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Catalunya

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Girona

State/Province

Catalunya

ZIP/Postal Code

17007

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de LLobregat

State/Province

Catalunya

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Tarragona

State/Province

Catalunya

ZIP/Postal Code

43005

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03010

Country

Spain

Facility Name

Novartis Investigative Site

City

Alzira

State/Province

Comunidad Valenciana

ZIP/Postal Code

46600

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Caceres

State/Province

Extremadura

ZIP/Postal Code

10003

Country

Spain

Facility Name

Novartis Investigative Site

City

La Coruna

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Novartis Investigative Site

City

Pontevedra

State/Province

Galicia

ZIP/Postal Code

36071

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma De Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07120

Country

Spain

Facility Name

Novartis Investigative Site

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian

State/Province

Pais Vasco

ZIP/Postal Code

20080

Country

Spain

Facility Name

Novartis Investigative Site

City

Granollers

ZIP/Postal Code

08402

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Novartis Investigative Site

City

Murcia

ZIP/Postal Code

30008

Country

Spain

Facility Name

Novartis Investigative Site

City

Santa Cruz de Tenerife

ZIP/Postal Code

38009

Country

Spain

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

SE-171 76

Country

Sweden

Facility Name

Novartis Investigative Site

City

East Yorkshire

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W12 0HS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

34123791

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.

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A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.

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A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML. (ENESTPath)

Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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