Trial Outcomes & Findings for Trial to Evaluate the Improvement of Chronic Low-grade AEs in Patients With Ph+ CML With Optimal Response to Imatinib When Switched to Nilotinib (NCT NCT02115386)
NCT ID: NCT02115386
Last Updated: 2019-12-10
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
7 participants
Primary outcome timeframe
at 6 month after switching from imatinib to nilotinib
Results posted on
2019-12-10
Participant Flow
Participant milestones
| Measure |
Nilotinib
Dosage was 300 mg BID daily taken orally without food.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Nilotinib
Dosage was 300 mg BID daily taken orally without food.
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Administrative - trial was terminated
|
6
|
Baseline Characteristics
Trial to Evaluate the Improvement of Chronic Low-grade AEs in Patients With Ph+ CML With Optimal Response to Imatinib When Switched to Nilotinib
Baseline characteristics by cohort
| Measure |
Nilotinib
n=7 Participants
Dosage was 300 mg BID daily taken orally without food.
|
|---|---|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 6 month after switching from imatinib to nilotinibImprovement 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.
Outcome measures
| Measure |
Nilotinib
n=7 Participants
Dosage was 300 mg BID daily taken orally without food.
|
|---|---|
|
Number of Participants With Improvement of Grades of Persistent Non-hematological Adverse Event (AE) for Grade 1 and 2 at 6 Months
|
0 participants
|
SECONDARY outcome
Timeframe: at 3 month after switching from imatinib to nilotinibImprovement 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.
Outcome measures
| Measure |
Nilotinib
n=7 Participants
Dosage was 300 mg BID daily taken orally without food.
|
|---|---|
|
Number of Participants With Improvement of Grades of Persistent Non-hematological Adverse Event (AE) for Grade 1 and 2 at 3 Months
|
0 participants
|
SECONDARY outcome
Timeframe: at months 6,12 and 24 after switching from imatinib to nilotinibCytogenetic 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.
Outcome measures
| Measure |
Nilotinib
n=6 Participants
Dosage was 300 mg BID daily taken orally without food.
|
|---|---|
|
Number of Participants With Complete Cytogenetic Response (CCyR)
|
0 participants
|
SECONDARY outcome
Timeframe: Months 1, 3, 6, early terminationMMR 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.
Outcome measures
| Measure |
Nilotinib
n=6 Participants
Dosage was 300 mg BID daily taken orally without food.
|
|---|---|
|
Number of Participants With a Major Molecular Response
Month 1
|
5 participants
|
|
Number of Participants With a Major Molecular Response
Month 3
|
6 participants
|
|
Number of Participants With a Major Molecular Response
Month 6
|
6 participants
|
|
Number of Participants With a Major Molecular Response
Early termination
|
5 participants
|
SECONDARY outcome
Timeframe: at 24 MonthsPopulation: No data collected for this Outcome Measure, as no participants reached month 24
to evaluate time to achievement and duration of CCyR and MMR after switching from imatinib to nilotinib
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: first improvement of AEs after switch to 24 MonthsPopulation: No data collected for this assessment, as no participants reached month 24
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, months 1, 3, 6, after switch to nilotinibEORTC-QLQ-C30 was administered to evaluate quality of life changes after switching to nilotinib. Scores ranged from 1 (very poor) to 6 (excellent)
Outcome measures
| Measure |
Nilotinib
n=7 Participants
Dosage was 300 mg BID daily taken orally without food.
|
|---|---|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient A Screening
|
3 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient A Month 1
|
3 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient A Month 3
|
3 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient A Month 6
|
3 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient A early termination
|
3 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient B screening
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient B Month 1
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient B Month 3
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient B Month 6
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient B early termination
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient C screening
|
4 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient C Month 1
|
4 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient C Month 3
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient C Month 6
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient C early termination
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient D screening
|
3 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient D Month 1
|
3 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient D Month 3
|
3 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient D Month 6
|
3 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient D early termination
|
4 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient E screening
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient E early termination
|
4 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient F screening
|
4 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient F Month 1
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient F Month 3
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient F Month 6
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient F early termination
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient G screening
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient G Month 1
|
4 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient G Month 3
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient G Month 6
|
5 score
|
|
Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life
Patient G early termination
|
5 score
|
Adverse Events
Nilotinib
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nilotinib
n=7 participants at risk
Nilotinib
|
|---|---|
|
Ear and labyrinth disorders
HYPOACUSIS
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Ear and labyrinth disorders
TINNITUS
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Gastrointestinal disorders
DRY MOUTH
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
General disorders
ASTHENIA
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Infections and infestations
PHARYNGITIS
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Investigations
LIPASE INCREASED
|
28.6%
2/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
42.9%
3/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Nervous system disorders
HEADACHE
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Nervous system disorders
PAROSMIA
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Psychiatric disorders
NERVOUSNESS
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
14.3%
1/7 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER