Trial Outcomes & Findings for An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast Crisis (NCT NCT00171158)
NCT ID: NCT00171158
Last Updated: 2021-06-25
Results Overview
Overall survival was defined as the number of events of death, expressed as a percentage, from the start of treatment to death, due to any reason.
COMPLETED
PHASE2
260 participants
From first dose until death of the patient, up to 14 years.
2021-06-25
Participant Flow
The overall study was conducted at 28 investigative sites in 6 countries from 26 July 1999 to 22 April 2013. A total of 260 participants were enrolled in the core Study CSTI57A0102, of which 21 participants completed the treatment and were enrolled in the extension Study CSTI571A0102E1. 13 participants discontinued from the extension Study CSTI571A0102E1, and 8 of them were enrolled in the extension Study CSTI571A0102E2.
The study enrolled 8 participants with myeloid blast crisis who completed their participation in Study CSTI571A0102E1.
Participant milestones
| Measure |
Imatinib Mesylate (STI571)
Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
|
|---|---|
|
Core Study
STARTED
|
260
|
|
Core Study
COMPLETED
|
21
|
|
Core Study
NOT COMPLETED
|
239
|
|
E2 Extension
STARTED
|
8
|
|
E2 Extension
COMPLETED
|
1
|
|
E2 Extension
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Imatinib Mesylate (STI571)
Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
|
|---|---|
|
Core Study
Death
|
27
|
|
Core Study
Unsatisfactory therapeutic effect
|
163
|
|
Core Study
Protocol Violation
|
4
|
|
Core Study
Administrative problems
|
1
|
|
Core Study
Adverse event, non-fatal
|
21
|
|
Core Study
Consent withdrawn by subject
|
6
|
|
Core Study
No longer required drug (BMT)
|
14
|
|
Core Study
Abnormal Laboratory Values
|
2
|
|
Core Study
Lost to Follow-up
|
1
|
|
E2 Extension
Other
|
7
|
Baseline Characteristics
An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast Crisis
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate (STI571)
n=260 Participants
Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg, on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose until death of the patient, up to 14 years.Population: The Intent-to-treat (ITT) population included all participants who enrolled in the study.
Overall survival was defined as the number of events of death, expressed as a percentage, from the start of treatment to death, due to any reason.
Outcome measures
| Measure |
Imatinib Mesylate (STI571)
n=260 Participants
Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg, on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
|
|---|---|
|
Overall Survival
|
89.2 percentage of participants
|
PRIMARY outcome
Timeframe: From first dose until death of the patient, up to 14 years.Population: The Intent-to-treat (ITT) population included all participants who enrolled in the study.
Overall survival was defined as the time between start of treatment and death due to any reason. Overall survival for the participants was calculated by Kaplan-Meier estimates per month. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up.
Outcome measures
| Measure |
Imatinib Mesylate (STI571)
n=260 Participants
Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg, on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
|
|---|---|
|
Overall Survival (by Month)
12 Months
|
32.7 percentage of participants
Interval 27.0 to 38.5
|
|
Overall Survival (by Month)
24 Months
|
18.7 percentage of participants
Interval 14.2 to 23.8
|
|
Overall Survival (by Month)
36 Months
|
15.4 percentage of participants
Interval 11.2 to 20.2
|
|
Overall Survival (by Month)
48 Months
|
14.5 percentage of participants
Interval 10.4 to 19.2
|
|
Overall Survival (by Month)
60 Months
|
9.1 percentage of participants
Interval 5.7 to 13.4
|
|
Overall Survival (by Month)
72 Months
|
8.4 percentage of participants
Interval 5.2 to 12.7
|
|
Overall Survival (by Month)
84 Months
|
7.5 percentage of participants
Interval 4.3 to 11.8
|
|
Overall Survival (by Month)
96 Months
|
7.5 percentage of participants
Interval 4.3 to 11.8
|
|
Overall Survival (by Month)
108 Months
|
7.5 percentage of participants
Interval 4.3 to 11.8
|
|
Overall Survival (by Month)
120 Months
|
6.6 percentage of participants
Interval 3.5 to 11.0
|
|
Overall Survival (by Month)
132 Months
|
5.5 percentage of participants
Interval 2.6 to 10.0
|
|
Overall Survival (by Month)
144 Months
|
5.5 percentage of participants
Interval 2.6 to 10.0
|
|
Overall Survival (by Month)
156 Months
|
5.5 percentage of participants
Interval 2.6 to 10.0
|
Adverse Events
Imatinib Mesylate (STI571)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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