Trial Outcomes & Findings for An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia (NCT NCT00171249)
NCT ID: NCT00171249
Last Updated: 2021-07-22
Results Overview
Hematologic response was evaluated from hematology measurements in the peripheral blood (PB) and bone marrow (BM) and assessments of extramedullary leukemic involvement (EMD) at physical examination. Response was defined as complete hematologic remission (CHR), no evidence of leukemia (NEL), or return to chronic phase (RTC).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
293 participants
Primary outcome timeframe
Up to 3 years after start of treatment
Results posted on
2021-07-22
Participant Flow
Participants took part in this study at 14 investigative sites in France, Germany, Italy, United Kingdom, Switzerland and United States from August 9, 1999 to September 23, 2013.
On July 31, 2002, the core study was completed and 76 participants on study medication were enrolled to the extension protocol #1 (E1), and as of July 31, 2004, 42 participants were still on treatment and were enrolled in a further extension protocol #2 (E2).
Participant milestones
| Measure |
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Lymphoid Blast Crisis 400 mg
Participants with lymphoid blast crisis received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Lymphoblastic Leukemia 400 mg
Participants with acute lymphoblastic leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Lymphoid Blast Crisis 600 mg
Participants with lymphoid blast crisis received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Lymphoblastic Leukemia 600 mg
Participants with acute lymphoblastic leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Myeloid/Myelogenous Leukemia 600 mg
Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
77
|
5
|
5
|
158
|
3
|
43
|
2
|
|
Overall Study
Completed Part 1
|
50
|
0
|
1
|
125
|
2
|
6
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
6
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
76
|
5
|
5
|
152
|
3
|
43
|
2
|
Reasons for withdrawal
| Measure |
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Lymphoid Blast Crisis 400 mg
Participants with lymphoid blast crisis received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Lymphoblastic Leukemia 400 mg
Participants with acute lymphoblastic leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Lymphoid Blast Crisis 600 mg
Participants with lymphoid blast crisis received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Lymphoblastic Leukemia 600 mg
Participants with acute lymphoblastic leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Myeloid/Myelogenous Leukemia 600 mg
Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
6
|
0
|
0
|
0
|
|
Overall Study
Unsatisfactory Therapeutic Effect
|
44
|
3
|
5
|
70
|
3
|
31
|
1
|
|
Overall Study
Death
|
7
|
1
|
0
|
4
|
0
|
3
|
1
|
|
Overall Study
Other
|
10
|
0
|
0
|
43
|
0
|
2
|
0
|
|
Overall Study
No Longer Requires Study Drug
|
4
|
0
|
0
|
3
|
0
|
5
|
0
|
|
Overall Study
Administrative Problems
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
3
|
1
|
0
|
15
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
0
|
9
|
0
|
0
|
0
|
Baseline Characteristics
An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph+ Leukemia
Baseline characteristics by cohort
| Measure |
STI571
n=293 Participants
Participants received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
Note- Data is reported with data that is available. No additional data tables were found that could provide results 'per arm' , therefore a summary arm has been reported.
|
|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 12.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years after start of treatmentPopulation: ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.
Hematologic response was evaluated from hematology measurements in the peripheral blood (PB) and bone marrow (BM) and assessments of extramedullary leukemic involvement (EMD) at physical examination. Response was defined as complete hematologic remission (CHR), no evidence of leukemia (NEL), or return to chronic phase (RTC).
Outcome measures
| Measure |
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg
n=77 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg
n=158 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Lymphoid Leukemia
Participants with acute lymphoid leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Myeloid/Myelogenous Leukemia
Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
|---|---|---|---|---|
|
Percentage of Participants With Hematologic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
|
64.9 percentage of participants
Interval 53.2 to 75.5
|
74.7 percentage of participants
Interval 67.2 to 81.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 years after start of treatmentPopulation: ITT population consists of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.
Bone marrow (BM) cytogenetic analysis was required at baseline, after 12 weeks (visit 22) and after 24 weeks (visit 28) to evaluate Ph chromosome positivity. In several participants, this was also done after 4 and 8 weeks. Based on the percentage of Philadelphia chromosome positive (Ph+) cells = (positive cells/examined cells)x100, at each BM assessment the cytogenetic response was classified as: Complete, 0% Ph+ cells; Partial, \>0 - 35% Ph+ cells; Minor, \>35 - 65% Ph+ cells; Minimal, \>65 - 95% Ph+ cells; None, \>95% Ph+ cells; Not done: \<20 metaphases were examined and/or response could not be assigned. Cytogenetic response was defined as confirmed complete or partial response. A BM sample was considered as assessable for cytogenetic response only if it contained ≥20 metaphases. However, an assessment of partial response was retained in a sample with \<20 metaphases when it was immediately preceded or followed by a complete or partial response in another sample with ≥20 metaphases.
Outcome measures
| Measure |
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg
n=77 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg
n=158 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Lymphoid Leukemia
Participants with acute lymphoid leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Myeloid/Myelogenous Leukemia
Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
|---|---|---|---|---|
|
Percentage of Participants With Cytogenetic Response in Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
|
14.3 percentage of participants
Interval 7.4 to 24.1
|
24.7 percentage of participants
Interval 18.2 to 32.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 years after start of treatmentPopulation: ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.
Time to response was defined for all participants as the time until first documented response (which was confirmed ≥4 weeks later).
Outcome measures
| Measure |
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg
n=77 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg
n=158 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Lymphoid Leukemia
Participants with acute lymphoid leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Myeloid/Myelogenous Leukemia
Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
|---|---|---|---|---|
|
Time to Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Hematologic response
|
0.95 months
Interval 0.95 to 1.1
|
0.99 months
Interval 0.99 to 1.0
|
—
|
—
|
|
Time to Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Cytogenetic response
|
2.83 months
Interval 1.9 to 5.6
|
2.96 months
Interval 2.8 to 5.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 years after start of treatmentPopulation: ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.
Duration of response was defined as the time between first documented response (which was confirmed ≥4 weeks later) and the earliest date of the following: loss of response (when any of the criteria for response were no longer fulfilled); progression to blast crisis (≥30% blasts in peripheral blood or bone marrow, extramedullary involvement other than liver/spleen enlargement); discontinuation due to adverse event, laboratory abnormality, unsatisfactory therapeutic effect or death.
Outcome measures
| Measure |
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg
n=77 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg
n=158 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Lymphoid Leukemia
Participants with acute lymphoid leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Myeloid/Myelogenous Leukemia
Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
|---|---|---|---|---|
|
Duration of Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Hematologic response
|
16.46 months
Interval 10.4 to 27.4
|
28.81 months
Interval 25.7 to
Upper limit of 95% CI was not estimable due to censored data
|
—
|
—
|
|
Duration of Response in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
Cytogenetic response
|
26.28 months
Interval 6.6 to
Upper limit of 95% CI was not estimable due to censored data
|
27.63 months
Interval 15.9 to
Upper limit of 95% CI was not estimable due to censored data
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 years after start of treatmentPopulation: ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants who belonged to the disease group of Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg or 600 mg only, as pre-specified in the protocol. The other three acute leukemia disease groups were exploratory only. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.
Progression to blast crisis was defined as ≥30% blasts in peripheral blood or bone marrow or as extramedullary involvement other than liver or spleen enlargement.
Outcome measures
| Measure |
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg
n=77 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg
n=158 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Lymphoid Leukemia
Participants with acute lymphoid leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Myeloid/Myelogenous Leukemia
Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
|---|---|---|---|---|
|
Time to Progression to Blast Crisis in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
|
9.95 months
Interval 6.6 to 14.4
|
25.13 months
Interval 18.1 to 29.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 months after start of treatmentPopulation: ITT population consisted of all enrolled participants. The data for this outcome measure was collected and analyzed in participants by disease groups. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.
To evaluate overall survival, all participants were followed after the last dose of study drug every month for the first three months and thereafter every three months until death. Overall survival was calculated for all participants as the time between start of treatment and death due to any reason. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up. For participants without survival follow-up information, the time was censored at last available visit/treatment date.
Outcome measures
| Measure |
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg
n=235 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg
n=8 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Lymphoid Leukemia
n=48 Participants
Participants with acute lymphoid leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Myeloid/Myelogenous Leukemia
n=2 Participants
Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
|---|---|---|---|---|
|
Overall Survival by Disease
156 months
|
18.9 percentage of participants
Interval 13.6 to 24.8
|
0 percentage of participants
Interval 0.0 to 0.0
|
5.6 percentage of participants
Interval 1.2 to 15.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
12 months
|
74.4 percentage of participants
Interval 68.3 to 79.5
|
12.5 percentage of participants
Interval 0.7 to 42.3
|
10.4 percentage of participants
Interval 3.8 to 20.9
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
24 months
|
58.8 percentage of participants
Interval 52.2 to 64.8
|
0 percentage of participants
Interval 0.0 to 0.0
|
8.3 percentage of participants
Interval 2.7 to 18.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
36 months
|
48 percentage of participants
Interval 41.4 to 54.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
8.3 percentage of participants
Interval 2.7 to 18.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
48 months
|
39.9 percentage of participants
Interval 33.5 to 46.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
8.3 percentage of participants
Interval 2.7 to 18.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
60 months
|
32.2 percentage of participants
Interval 26.1 to 38.4
|
0 percentage of participants
Interval 0.0 to 0.0
|
8.3 percentage of participants
Interval 2.7 to 18.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
72 months
|
26.3 percentage of participants
Interval 20.6 to 32.3
|
0 percentage of participants
Interval 0.0 to 0.0
|
8.3 percentage of participants
Interval 2.7 to 18.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
84 months
|
24.1 percentage of participants
Interval 18.6 to 30.1
|
0 percentage of participants
Interval 0.0 to 0.0
|
8.3 percentage of participants
Interval 2.7 to 18.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
96 months
|
21.9 percentage of participants
Interval 16.5 to 27.8
|
0 percentage of participants
Interval 0.0 to 0.0
|
5.6 percentage of participants
Interval 1.2 to 15.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
108 months
|
20.6 percentage of participants
Interval 15.3 to 26.4
|
0 percentage of participants
Interval 0.0 to 0.0
|
5.6 percentage of participants
Interval 1.2 to 15.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
120 months
|
20.6 percentage of participants
Interval 15.3 to 26.4
|
0 percentage of participants
Interval 0.0 to 0.0
|
5.6 percentage of participants
Interval 1.2 to 15.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
132 months
|
18.9 percentage of participants
Interval 13.6 to 24.8
|
0 percentage of participants
Interval 0.0 to 0.0
|
5.6 percentage of participants
Interval 1.2 to 15.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Overall Survival by Disease
144 months
|
18.9 percentage of participants
Interval 13.6 to 24.8
|
0 percentage of participants
Interval 0.0 to 0.0
|
5.6 percentage of participants
Interval 1.2 to 15.2
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132 months after start of treatmentPopulation: ITT population consisted of all enrolled participants. The overall survival was calculated as per initial dose (400 mg or 600 mg) only for participants with Accelerated Phase Chronic Myeloid/Myelogenous Leukemia, as pre-specified in the protocol. Data is reported with data that is available. No additional data tables were found that could provide results with arms broken down any further.
To evaluate overall survival, all participants were followed after the last dose of study drug every month for the first three months and thereafter every three months until death. Overall survival was calculated for all participants as the time between start of treatment and death due to any reason. The time was censored at the date of last contact for participants who discontinued treatment and were in survival follow-up. For participants without survival follow-up information, the time was censored at last available visit/treatment date.
Outcome measures
| Measure |
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 400 mg
n=77 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 400 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Accelerated Phase Chronic Myeloid/Myelogenous Leukemia 600 mg
n=158 Participants
Participants with accelerated phase chronic myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Lymphoid Leukemia
Participants with acute lymphoid leukemia received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
Acute Myeloid/Myelogenous Leukemia
Participants with acute myeloid/myelogenous leukemia received STI571 600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
|
|---|---|---|---|---|
|
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
12 months
|
64.5 percentage of participants
Interval 52.6 to 74.1
|
79.1 percentage of participants
Interval 71.9 to 84.7
|
—
|
—
|
|
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
24 months
|
44.3 percentage of participants
Interval 32.9 to 55.1
|
65.7 percentage of participants
Interval 57.7 to 72.6
|
—
|
—
|
|
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
36 months
|
34.9 percentage of participants
Interval 24.4 to 45.7
|
54.2 percentage of participants
Interval 46.0 to 61.6
|
—
|
—
|
|
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
48 months
|
28.0 percentage of participants
Interval 18.4 to 38.5
|
45.6 percentage of participants
Interval 37.6 to 53.2
|
—
|
—
|
|
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
60 months
|
23.7 percentage of participants
Interval 14.7 to 33.9
|
36.2 percentage of participants
Interval 28.6 to 43.9
|
—
|
—
|
|
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
72 months
|
18.6 percentage of participants
Interval 10.5 to 28.5
|
29.9 percentage of participants
Interval 22.6 to 37.5
|
—
|
—
|
|
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
84 months
|
15.2 percentage of participants
Interval 7.8 to 24.8
|
28.3 percentage of participants
Interval 21.2 to 35.9
|
—
|
—
|
|
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
96 months
|
11.8 percentage of participants
Interval 5.4 to 21.0
|
26.6 percentage of participants
Interval 19.6 to 34.2
|
—
|
—
|
|
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
108 months
|
11.8 percentage of participants
Interval 5.4 to 21.0
|
24.8 percentage of participants
Interval 17.9 to 32.3
|
—
|
—
|
|
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
120 months
|
11.8 percentage of participants
Interval 5.4 to 21.0
|
24.8 percentage of participants
Interval 17.9 to 32.3
|
—
|
—
|
|
Overall Survival by Dose in Participants With Accelerated Phase Chronic Myeloid/Myelogenous Leukemia
132 months
|
11.8 percentage of participants
Interval 5.4 to 21.0
|
22.3 percentage of participants
Interval 15.4 to 29.9
|
—
|
—
|
Adverse Events
STI571
Serious events: 20 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STI571
n=293 participants at risk
Participants received STI571 400/600 mg, orally, once daily, until death, the development of intolerable toxicity, or the investigator felt it was no longer in the participant's best interest to continue therapy, whichever came first.
Note- Data is reported with data that is available. No additional data tables were found that could provide results 'per arm' , therefore a summary arm has been reported.
|
|---|---|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.68%
2/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
General disorders
Death
|
0.68%
2/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
|
Infections and infestations
Pneumonia
|
0.34%
1/293 • Up to approximately 14 years
AEs were not collected separately for each disease and dose groups of participants. The data has been reported as originally produced by the team at the time of reporting. We have exhausted all efforts to locate additional data; therefore, no additional data is available to report or modify what has previously been reported. No other non-serious AEs were collected during extension phase within clinical database.
|
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER