MedDataX Logo

Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.

NCT ID: NCT02546674

Last Updated: 2022-07-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-18

Study Completion Date

2021-03-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main purpose of this study was to evaluate the rate of deep molecular response (MR4.5) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase chronic myeloid leukemia (CML) using EUTOS (European Treatment and Outcome Study for CML)-standardized laboratories. All participants received nilotinib 300 mg twice daily (BID).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

NCT01227577

Chronic Myelogenous Leukemia in Chronic Phase
COMPLETED PHASE4

Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response

NCT01043874

Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
COMPLETED PHASE4

Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML)

NCT00129740

Leukemia, Myelogenous, Chronic
COMPLETED PHASE2

Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase

NCT01061177

CML in Chronic Phase
COMPLETED PHASE4

Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

NCT00644878

Chronic Myelogenous Leukemia - Chronic Phase
TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This was a Phase IV open-label, multi-center, single-arm study in participants with newly diagnosed Philadelphia chromosome positive (Ph+) CML in chronic phase for who nilotinib is the appropriate treatment at the discretion of the investigator.

A screening period of 2 weeks was used to assess eligibility and to taper participants off disallowed medications. Participants whose eligibility was confirmed entered a 24 months treatment phase with nilotinib 300mg BID. Nilotinib was prescribed by the investigator according to the individual needs of the participants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Myeloid Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nilotinib

Participants with newly diagnosed CML in chronic phase received nilotinib 300 mg BID for 24 months

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

A daily dose of 300 mg was given to all participants as two 150 mg capsules BID. The prescription of study drug was not study dependent and followed medical needs of the participant only. The study treatment was administered for 24 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nilotinib

A daily dose of 300 mg was given to all participants as two 150 mg capsules BID. The prescription of study drug was not study dependent and followed medical needs of the participant only. The study treatment was administered for 24 months.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AMN107

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with newly diagnosed (within 6 months) Philadelphia chromosome positive CML in chronic phase
* Patients must be previously untreated for CML with the exception of 6 months treatment with hydroxyurea and a maximum of 6 weeks treatment with imatinib
* Adequate end organ function
* Normal serum levels ≥ lower limit of normal (LLN) of potassium, magnesium, total calcium corrected for serum albumin or phosphorus, or correctable to within normal limits with supplements, prior to the first dose of study medication.

Exclusion Criteria

* Known impaired cardiac function like long QT syndrome, history of myocardial infarction or unstable angina in the past 12 months.
* Patients who are pregnant or breast feeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, Germany

Site Status

Novartis Investigative Site

Herne, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Lübeck, Schleswig-Holstein, Germany

Site Status

Novartis Investigative Site

Aschaffenburg, , Germany

Site Status

Novartis Investigative Site

Augsburg, , Germany

Site Status

Novartis Investigative Site

Bad Mergentheim, , Germany

Site Status

Novartis Investigative Site

Bad Reichenhall, , Germany

Site Status

Novartis Investigative Site

Bad Saarow, , Germany

Site Status

Novartis Investigative Site

Bad Soden, , Germany

Site Status

Novartis Investigative Site

Bamberg, , Germany

Site Status

Novartis Investigative Site

Bayreuth, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Biberach, , Germany

Site Status

Novartis Investigative Site

Bremerhaven, , Germany

Site Status

Novartis Investigative Site

Chemnitz, , Germany

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Donauwörth, , Germany

Site Status

Novartis Investigative Site

Dresden, , Germany

Site Status

Novartis Investigative Site

Düsseldorf, , Germany

Site Status

Novartis Investigative Site

Düsseldorf, , Germany

Site Status

Novartis Investigative Site

Erfurt, , Germany

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Georgsmarienhütte, , Germany

Site Status

Novartis Investigative Site

Giessen, , Germany

Site Status

Novartis Investigative Site

Goslar, , Germany

Site Status

Novartis Investigative Site

Göppingen, , Germany

Site Status

Novartis Investigative Site

Halberstadt, , Germany

Site Status

Novartis Investigative Site

Halle, , Germany

Site Status

Novartis Investigative Site

Halle S, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Novartis Investigative Site

Jena, , Germany

Site Status

Novartis Investigative Site

Kassel, , Germany

Site Status

Novartis Investigative Site

Kiel, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Magdeburg, , Germany

Site Status

Novartis Investigative Site

Memmingen, , Germany

Site Status

Novartis Investigative Site

Minden, , Germany

Site Status

Novartis Investigative Site

Moers, , Germany

Site Status

Novartis Investigative Site

Mutlangen, , Germany

Site Status

Novartis Investigative Site

Mülheim, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Münster, , Germany

Site Status

Novartis Investigative Site

Nuremberg, , Germany

Site Status

Novartis Investigative Site

Nuremberg, , Germany

Site Status

Novartis Investigative Site

Oldenburg, , Germany

Site Status

Novartis Investigative Site

Paderborn, , Germany

Site Status

Novartis Investigative Site

Passau, , Germany

Site Status

Novartis Investigative Site

Potsdam, , Germany

Site Status

Novartis Investigative Site

Rostock, , Germany

Site Status

Novartis Investigative Site

Rotenburg (Wümme), , Germany

Site Status

Novartis Investigative Site

Saarbrücken, , Germany

Site Status

Novartis Investigative Site

Schorndorf, , Germany

Site Status

Novartis Investigative Site

Schwäbisch Hall, , Germany

Site Status

Novartis Investigative Site

Schweinfurt, , Germany

Site Status

Novartis Investigative Site

Tübingen, , Germany

Site Status

Novartis Investigative Site

Velbert, , Germany

Site Status

Novartis Investigative Site

Westerstede, , Germany

Site Status

Novartis Investigative Site

Wiesbaden, , Germany

Site Status

Novartis Investigative Site

Wilhelmshaven, , Germany

Site Status

Novartis Investigative Site

Wolfsburg, , Germany

Site Status

Novartis Investigative Site

Worms, , Germany

Site Status

Novartis Investigative Site

Würzburg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://www.leukaemie-online.de/studien/70-studie-erstlinie/1198-nilo-deep-r-studie

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-000968-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAMN107ADE20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy of Nilotinib Versus Imatinib in Ph+ CML in Early CP Who Have a Suboptimal Molecular Response to Imatinib
NCT01400074 UNKNOWN PHASE3
Nilotinib for Patients With Chronic Myeloid Leukemia in First Line and Any Subsequent Line
NCT05734053 COMPLETED
An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years
NCT02174445 TERMINATED PHASE3
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
NCT01844765 COMPLETED PHASE2
Nilotinib for First-line Newly Diagnosed CML-CP Patients
NCT03942094 UNKNOWN PHASE3
Safety and Tolerability of Combined Treatment With Nilotinib and Ruxolitinib in CML and Ph+ ALL Patients
NCT02253277 COMPLETED PHASE1
Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients
NCT01254188 COMPLETED PHASE3
Pegylated Interferon Alfa-2b and Nilotinib for Augmentation of Complete Molecular Response in Chronic Myeloid Leukaemia
NCT02001818 COMPLETED PHASE2
Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
NCT01274351 COMPLETED PHASE2
Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)
NCT01279473 COMPLETED PHASE1/PHASE2
Nilotinib 300 mg BID in Newly Diagnosed CP-CML Patients to Verify Disappearance of CD34+/Lin-Ph+ Cells
NCT01856283 COMPLETED PHASE2
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
NCT05456191 ACTIVE_NOT_RECRUITING PHASE3
Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations
NCT01131325 TERMINATED PHASE4
Nilotinib and LDE225 in the Treatment of Chronic or Accelerated Phase Myeloid Leukemia in Patients Who Developed Resistance to Prior Therapy
NCT01456676 COMPLETED PHASE1
Nilotinib in PH+, BCR-, ABL+ CML Patients
NCT01535391 COMPLETED PHASE3
Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
NCT00809211 COMPLETED PHASE2
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation
NCT01744665 COMPLETED PHASE2
Nilotinib + Pegylated Interferon Alpha 2a for Untreated Chronic Phase Chronic Myelogenous Leukemia
NCT01294618 COMPLETED PHASE2
Study to Assess Efficacy and Safety of Nilotinib 300mg Twice Daily in Patients With Philadelphia Positive Chronic Myeloid Leukaemia (CML) in Chronic Phase Who Are Intolerant to Prior Tyrosine Kinase Inhibitors.
NCT02108951 TERMINATED PHASE3
Nilotinib Plus Pegylated Interferon-α2b in CML
NCT01866553 TERMINATED PHASE2
Trial Evaluating Nilotinib as Treatment for Newly Diagnosed CML Patients in Accelerated Phase.
NCT01605981 WITHDRAWN PHASE4
Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)
NCT00760877 COMPLETED PHASE3
Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
NCT01784068 COMPLETED PHASE2
Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients
NCT02201459 COMPLETED PHASE3
A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.
NCT01743989 COMPLETED PHASE3