A Phase 2 interventional study of Glivec in Myeloid Leukemia, Chronic, sponsored by Institut Bergonié. Terminated at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by Institut Bergonié · Phase 2, Interventional, and Treatment
Imatinib mesylate is standard treatment of Chronic myeloid leukaemia, complete cytogenetic response is obtained in most of cases but molecular response concerned only a small part of the patients. To increase molecular response ratio we decided to increase imatinib dose to limited resistance to this drug and to add zoledronate for it anti tumoral activity to increase anti leukemic effect. We plan to accrue 37 patients in 5 centers. We will analyse molecular expression of BCR-ABL transcript after 6 months of treatment, safety, duration of response, VEGF expression and LTgd production.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 19 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.
Drug: Glivec
Percentage of Participants With Molecular Response
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
Time frame: 6 months
Percentage of Participants With a Reduction of BCR-ABL Transcript Level > 4.5 Log From the Start of From Initiation of Treatment
reduction of BCR-ABL transcript level \> 4.5 Log from the start of from initiation of treatment
Time frame: 6 months
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.
| Milestone | Imatinib Mesylate |
|---|---|
| Started | 19 |
| Completed | 17 |
| Not completed | 2 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Withdrawal by subject | 1 |
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
| percentage of participants | Imatinib Mesylate |
|---|---|
| Percentage of Participants With Molecular Response | 0 (0 to 0) |
reduction of BCR-ABL transcript level \> 4.5 Log from the start of from initiation of treatment
| percentage of participants | Imatinib Mesylate |
|---|---|
| Percentage of Participants With a Reduction of BCR-ABL Transcript Level > 4.5 Log From the Start of From Initiation of Treatment | 0 (0 to 0) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Imatinib Mesylate | — | 1/17 (5.9%) | — |
| Event | Imatinib Mesylate |
|---|---|
| Pulmonary edemaRespiratory, thoracic and mediastinal disorders | 1/17 |
| Age, Continuous(years) | Imatinib Mesylate |
|---|---|
| Median | 58.4 (32.7 to 74.0) |
| Sex: Female, Male(Participants) | Imatinib Mesylate |
|---|---|
| Female | 3 |
| Male | 16 |
| Region of Enrollment(Participants) | Imatinib Mesylate |
|---|---|
| France | 19 |
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut Bergonié