Trial Outcomes & Findings for Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response (NCT NCT00210119)
NCT ID: NCT00210119
Last Updated: 2021-11-08
Results Overview
A patient is considered to be in molecular response if at least one of the following conditions is observed : \- a complete molecular response at 6 months defined by PCR negativation tested on twice OR \- reduction of BCR-ABL transcript level \> 2 Log from the start of from initiation of treatment
TERMINATED
PHASE2
19 participants
6 months
2021-11-08
Participant Flow
The AFR-22 trial was based on a two-stage Simon's design, which included 17 patients in the first stage, followed by an additional 20 patients. Analysis of the first 17 evaluable patients showed insufficient efficacy of the study treatment. In accordance with the principle of Simon's two-stage design, enrollment was stopped.
Participant milestones
| Measure |
Imatinib Mesylate
Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.
Glivec
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Imatinib Mesylate
Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.
Glivec
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response
Baseline characteristics by cohort
| Measure |
Imatinib Mesylate
n=19 Participants
Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.
Glivec
|
|---|---|
|
Age, Continuous
|
58.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 2 patients were not assessable for the primary outcome measure : 1 not eligible and 1 not treated because of withdrawal
A patient is considered to be in molecular response if at least one of the following conditions is observed : \- a complete molecular response at 6 months defined by PCR negativation tested on twice OR \- reduction of BCR-ABL transcript level \> 2 Log from the start of from initiation of treatment
Outcome measures
| Measure |
Imatinib Mesylate
n=17 Participants
Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.
Glivec
|
|---|---|
|
Percentage of Participants With Molecular Response
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 2 patients were not assessable for secondary outcome measures
reduction of BCR-ABL transcript level \> 4.5 Log from the start of from initiation of treatment
Outcome measures
| Measure |
Imatinib Mesylate
n=17 Participants
Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.
Glivec
|
|---|---|
|
Percentage of Participants With a Reduction of BCR-ABL Transcript Level > 4.5 Log From the Start of From Initiation of Treatment
|
0 percentage of participants
Interval 0.0 to 0.0
|
Adverse Events
Imatinib Mesylate
Serious adverse events
| Measure |
Imatinib Mesylate
n=17 participants at risk
Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.
Glivec
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
5.9%
1/17 • Number of events 1
Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place