Overview

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

Status:
Terminated
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut Bergonié
Collaborator:
Novartis
Treatments:
Diphosphonates
Imatinib Mesylate
Zoledronic acid
Criteria
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:

- · 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