Trial Outcomes & Findings for Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia (NCT NCT00015847)
NCT ID: NCT00015847
Last Updated: 2025-08-22
Results Overview
Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows: Complete\* (0% Ph-positive cells) Partial\* (1-34%) Minor (35-95%) None (96-100%).
TERMINATED
PHASE2
25 participants
At 6 and 12 months during phase II
2025-08-22
Participant Flow
Participant milestones
| Measure |
Imatinib Mesylate
Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate
n=25 Participants
Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At 6 and 12 months during phase IICytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows: Complete\* (0% Ph-positive cells) Partial\* (1-34%) Minor (35-95%) None (96-100%).
Outcome measures
| Measure |
Imatinib Mesylate
n=25 Participants
Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
|
|---|---|
|
Complete Cytogenetic Response at 6 and 12 Months (Phase II)
|
13 Participants
|
PRIMARY outcome
Timeframe: At 6 and 12 months during phase IIPopulation: The reason why remaining outcomes can not be reported is due to loss of the study data. Results published 13 years ago were only partial at the time despite having overlapping timeframes with other outcomes. Efforts made since to locate original data to report remaining outcomes were unsuccessful due to early termination and staff turnover.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At 6 and 12 months during phase IIPopulation: The reason why remaining outcomes can not be reported is due to loss of the study data. Results published 13 years ago were only partial at the time despite having overlapping timeframes with other outcomes. Efforts made since to locate original data to report remaining outcomes were unsuccessful due to early termination and staff turnover.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At 6 and 12 months during phase IIPopulation: The reason why remaining outcomes can not be reported is due to loss of the study data. Results published 13 years ago were only partial at the time despite having overlapping timeframes with other outcomes. Efforts made since to locate original data to report remaining outcomes were unsuccessful due to early termination and staff turnover.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 Months1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death
Outcome measures
| Measure |
Imatinib Mesylate
n=25 Participants
Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
|
|---|---|
|
Treatment-related Toxicity (i.e., Grade 3 or 4 Nonhematologic Toxicity) as Measured by NCI CTCAE v3.0 (Phase I)
|
8 Participants
|
PRIMARY outcome
Timeframe: 6 and 12 months after treatmentCytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows: Complete\* (0% Ph-positive cells) Partial\* (1-34%) Minor (35-95%) None (96-100%). \*Major cytogenetic response includes complete and partial cytogenetic response.
Outcome measures
| Measure |
Imatinib Mesylate
n=25 Participants
Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
|
|---|---|
|
Major Cytogenetic Response After 6 and 12 Months of Treatment.
|
18 Participants
|
Adverse Events
Imatinib Mesylate
Serious adverse events
| Measure |
Imatinib Mesylate
n=25 participants at risk
Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
|
|---|---|
|
General disorders
Fatigue
|
4.0%
1/25 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
4.0%
1/25 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • Number of events 4
|
|
Hepatobiliary disorders
Elevated Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)
|
12.0%
3/25 • Number of events 6
|
|
Infections and infestations
Infection
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • Number of events 3
|
Other adverse events
| Measure |
Imatinib Mesylate
n=25 participants at risk
Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
|
|---|---|
|
General disorders
Chills
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
3/25
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
8.0%
2/25
|
|
Psychiatric disorders
Depression
|
8.0%
2/25
|
|
General disorders
Headache
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Gout
|
8.0%
2/25
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
8.0%
2/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place