Status:
TERMINATED
Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response
Lead Sponsor:
Institut Bergonié
Collaborating Sponsors:
Novartis
Conditions:
Myeloid Leukemia, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- · 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
Key Trial Info
Start Date :
July 12 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00210119
Start Date
July 12 2006
End Date
March 1 2009
Last Update
November 8 2021
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33076
2
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
3
Centre Hospitalier de Versailles
Le Chesnay, France, 78150
4
Hôpital Edouard Herriot
Lyon, France, 69437