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TerminatedNCT00210119AFR22Updated Nov 8, 2021Results posted

Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response

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

Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Myeloid Leukemia, Chronic

Keywords

  • Chronic myeloid leukemia
  • imatinib mesylate
  • zoledronate
  • molecular response
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In context

Leukemia

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Inclusion criteria: at registration· Chronic myeloid leukaemia Ph+ confirmed by cytogenetic analysis or BCR-ABL translocation by molecular biology· Chronic phase:-\<15% blast cells in blood and 5% in bone marrow-\<30% blast cells+promyelocyte cells in blood and bone marrow-\<20% basophils in blood->100.000 platelets· Without extra medullar attempt excepted hepatosplenomagalia· First line of treatment· Biology and biochemistry with normal levels· Male or female>18 years old· Signed written consent· ECOG\<3At inclusion· Chronic myeloid leukaemia with cytogenetic response without molecular response after one year of treatment by imatinib and BCR-ABL transcript detected by RT-PCR

Exclusion criteria

Exclusion Criteria:

    • Other cancer excepted basocellular or cervix carcinoma · Major surgery in last 2 weeks previous inclusion· Women who are pregnant or breastfeeding (are unable to use an acceptable method to avoid pregnancy of his partner for the entire study period)· Dementia or altered mental status that would prohibit the understanding or rendering of informed consent · Abnormal renal function with creatinine clearance \< 30 ml/ minuteAccording to Cockcroft-Gault : CrCl= [[140-age (years)] x weight (kg)]/ [72 x serum creatinine (mg/dL)] {x 0.85 for women}· Chronic myeloid leukaemia in acute phase or in pass to be in acute phase · Treatment with bisphosphonates in last 6 months previous inclusion · Intolerance to bisphosphonates: hypersensitivity, on course dental problem, including tooth or mandibular infection; dental traumatism or recent diagnosis or previous mandibular osteonecrosis, or dental extraction with cicatrisation delay or necessity to set bone evidence · Mandibular surgery in last 6 weeks or planned in the future during treatment (tooth extraction)· Serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy: diabetes, thyroid pathology, neuropsychiatric illness, myocardial infarction or congestive heart failure grade 3-4 according to " New York Heart association"· History of psychiatric or depressive pathology · HIV positivity known · Inclusion in other study investigating antineoplastic molecule in last 30 days previous inclusion
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Imatinib mesylate

    Imatinib mesylate 600 or 800 mg/day PO + zoledronate 4 mg IV over 15 min every 3 weeks for 6 months.

    Drug: Glivec

Interventions

  • DrugGlivec
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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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Results

Posted Oct 28, 2021

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 flow — Overall Study
MilestoneImatinib Mesylate
Started19
Completed17
Not completed2
Withdrew: Protocol violation1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Molecular Response
percentage of participantsImatinib Mesylate
Percentage of Participants With Molecular Response0 (0 to 0)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With a Reduction of BCR-ABL Transcript Level > 4.5 Log From the Start of From Initiation of Treatment
percentage of participantsImatinib Mesylate
Percentage of Participants With a Reduction of BCR-ABL Transcript Level > 4.5 Log From the Start of From Initiation of Treatment0 (0 to 0)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Imatinib Mesylate—1/17 (5.9%)—
Most frequent serious events
Most frequent serious events
EventImatinib Mesylate
Pulmonary edemaRespiratory, thoracic and mediastinal disorders1/17

Baseline characteristics

Age, Continuous
Age, Continuous(years)Imatinib Mesylate
Median58.4 (32.7 to 74.0)
Sex: Female, Male
Sex: Female, Male(Participants)Imatinib Mesylate
Female3
Male16
Region of Enrollment
Region of Enrollment(Participants)Imatinib Mesylate
France19
08

Study locations

7 sites
  • Centre Hospitalier Universitaire de Bordeaux
    Bordeaux, 33076, France
  • Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
    Bordeaux, 33076, France
  • Centre Hospitalier de Versailles
    Le Chesnay, 78150, France
  • Hôpital Edouard Herriot
    Lyon, 69437, France
  • Hôpital Archet
    Nice, 06200, France
  • Hôpital Saint Louis
    Paris, 75010, France
  • Centre Hospitalier Universitaire de Poitiers
    Poitiers, 86000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00210119
Lead sponsor
Institut Bergonié
Collaborators
Novartis
First posted
Sep 21, 2005
Start date
Jul 12, 2006
Primary completion
Sep 2007
Completion
Mar 2009
Results posted
Oct 28, 2021
Last update
Nov 8, 2021

Study contacts

Josy REIFFERS, Pr
principal investigator · Institut Bergonié
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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