Trial Outcomes & Findings for Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease (NCT NCT00267085)
NCT ID: NCT00267085
Last Updated: 2012-08-07
Results Overview
Molecular response defined as reduction by one log of the circulating peripheral blood for reverse transcription polymerase chain reaction (RT-PCR) transcripts of BCR-ABL (tumor-specific oncogenic fusion protein) after two consecutive measurements. RT-PCR performed at 3 month intervals. Response categorized as either 'No Decrease' or 'Decrease' if one log reduction in BCR-ABL detected.
COMPLETED
PHASE2
11 participants
12 months
2012-08-07
Participant Flow
Recruitment Period 12/2/05 to 7/1/08. All participants registered at The University of Texas M.D. Anderson Cancer Center.
Eleven participants were registered, one was excluded from study enrollment and did not receive the Chronic Myeloid Leukemia (CML) Vaccine.
Participant milestones
| Measure |
CML Vaccine
Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease
Baseline characteristics by cohort
| Measure |
CML Vaccine
n=10 Participants
Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
45 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All 10 participants on study received treatment and were included in analysis.
Molecular response defined as reduction by one log of the circulating peripheral blood for reverse transcription polymerase chain reaction (RT-PCR) transcripts of BCR-ABL (tumor-specific oncogenic fusion protein) after two consecutive measurements. RT-PCR performed at 3 month intervals. Response categorized as either 'No Decrease' or 'Decrease' if one log reduction in BCR-ABL detected.
Outcome measures
| Measure |
CML Vaccine
n=10 Participants
Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
|
|---|---|
|
Response: One Log Decrease in BCR-ABL
Decrease
|
3 Participants
|
|
Response: One Log Decrease in BCR-ABL
No Decrease
|
7 Participants
|
Adverse Events
CML Vaccine
Serious adverse events
| Measure |
CML Vaccine
n=10 participants at risk
Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
|
|---|---|
|
General disorders
Neck Pain
|
10.0%
1/10 • Number of events 1 • 2 years 3 months
|
|
General disorders
Back Pain
|
10.0%
1/10 • Number of events 1 • 2 years 3 months
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • 2 years 3 months
|
Other adverse events
| Measure |
CML Vaccine
n=10 participants at risk
Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
10.0%
1/10 • Number of events 1 • 2 years 3 months
|
|
Skin and subcutaneous tissue disorders
Bruising
|
20.0%
2/10 • Number of events 2 • 2 years 3 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin (other)
|
10.0%
1/10 • Number of events 2 • 2 years 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
4/10 • Number of events 4 • 2 years 3 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
10.0%
1/10 • Number of events 1 • 2 years 3 months
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 9 • 2 years 3 months
|
|
General disorders
Fever without neutropenia
|
10.0%
1/10 • Number of events 1 • 2 years 3 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
100.0%
10/10 • Number of events 31 • 2 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/paranasal reactions
|
10.0%
1/10 • Number of events 1 • 2 years 3 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • 2 years 3 months
|
|
General disorders
Pain (joint)
|
20.0%
2/10 • Number of events 2 • 2 years 3 months
|
|
General disorders
Pain (muscle)
|
30.0%
3/10 • Number of events 4 • 2 years 3 months
|
|
General disorders
Pain (NOS)
|
10.0%
1/10 • Number of events 1 • 2 years 3 months
|
|
General disorders
Pain (Other)
|
20.0%
2/10 • Number of events 2 • 2 years 3 months
|
|
Skin and subcutaneous tissue disorders
Pruitis
|
50.0%
5/10 • Number of events 8 • 2 years 3 months
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
20.0%
2/10 • Number of events 3 • 2 years 3 months
|
|
General disorders
Sweating
|
10.0%
1/10 • Number of events 1 • 2 years 3 months
|
Additional Information
Jorge Cortes M.D./Professor
The University of Texas M. D. Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place