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Trial to Evaluate the Improvement of Chronic Low-grade AEs in Patients With Ph+ CML With Optimal Response to Imatinib When Switched to Nilotinib

Phase 3
Terminated
Conditions
Philadelphia Positive (Ph+) Chronic Myeloid Leukemia
Interventions
Registration Number
NCT02115386
Lead Sponsor
Novartis Pharmaceuticals
Brief Summary

Primary Objective for this study is to evaluate changes in chronic low grade non-hematological adverse events experienced by patients who have been treated with at least 6 months of imatinib and who have not responded to supportive measures, when they are switched to nilotinib (CTCAE grading system).

Detailed Description

Study was terminated by Novartis

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
7
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
NilotinibNilotinibDosage was 300 mg BID daily taken orally without food.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Improvement of Grades of Persistent Non-hematological Adverse Event (AE) for Grade 1 and 2 at 6 Monthsat 6 month after switching from imatinib to nilotinib

Improvement was defined as decreasing of grade of non-hematological toxicity from 2 to \<2 or from 1 to \<1. In case of multiple low-grade non-hematological toxicities improvement was defined as an improvement of at least one non-hematological AE and no worsening of any other persistent non-hematological AEs.

Secondary Outcome Measures
NameTimeMethod
Lisiting by Participant of EORTC-QLQ-C30 for Quality of LifeScreening, months 1, 3, 6, after switch to nilotinib

EORTC-QLQ-C30 was administered to evaluate quality of life changes after switching to nilotinib. Scores ranged from 1 (very poor) to 6 (excellent)

Number of Participants With Improvement of Grades of Persistent Non-hematological Adverse Event (AE) for Grade 1 and 2 at 3 Monthsat 3 month after switching from imatinib to nilotinib

Improvement was defined as decreasing of grade of non-hematological toxicity from 2 to \<2 or from 1 to \<1. In case of multiple low-grade non-hematological toxicities improvement was defined as an improvement of at least one non-hematological AE and no worsening of any other persistent non-hematological AEs.

Number of Participants With Complete Cytogenetic Response (CCyR)at months 6,12 and 24 after switching from imatinib to nilotinib

Cytogenetic response will be assessed as the percentage of Ph+ metaphases in the bone marrow and is defined as the following: Complete (CCyR) - 0% Ph+ metaphases.

Number of Participants With a Major Molecular ResponseMonths 1, 3, 6, early termination

MMR was defined as a ≥ 3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤ 0.1 % BCR-ABL/ABL % by international scale as measured by RQ-PCR, confirmed by duplicate analysis of the same sample. Molecular response was described for all time points except screening where response was estimated.

Time to and Duration of CCyR and MMR After Switch From Imatinib to Nilotinib at 24 Monthsat 24 Months

to evaluate time to achievement and duration of CCyR and MMR after switching from imatinib to nilotinib

Time to First Improvement of Persistant Chronic Low-grade Non-hematologic AEs at 24 Months After Switch From Imatinib to Nilotinibfirst improvement of AEs after switch to 24 Months

Evaluate time to first improvement of low-grade non-hematologic adverse events, experienced by patients treated with imatinib and persistent despite of best supportive measures after switching to nilotinib therapy. Optimal improvement is defined as AE grade decreasing to 0.

Trial Locations

Locations (1)

Novartis Investigative Site

🇷🇺

Moscow, Russian Federation

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