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

NCT ID: NCT00210119

Last Updated: 2021-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-12

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myeloid Leukemia, Chronic

Keywords

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Chronic myeloid leukemia imatinib mesylate zoledronate molecular response

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imatinib mesylate

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

Group Type EXPERIMENTAL

Glivec

Intervention Type DRUG

Interventions

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Glivec

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Institut Bergonié

OTHER

Sponsor Role lead

Principal Investigators

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Josy REIFFERS, Pr

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

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Centre Hospitalier Universitaire de Bordeaux

Bordeaux, , France

Site Status

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

Bordeaux, , France

Site Status

Centre Hospitalier de Versailles

Le Chesnay, , France

Site Status

Hôpital Edouard Herriot

Lyon, , France

Site Status

Hôpital Archet

Nice, , France

Site Status

Hôpital Saint Louis

Paris, , France

Site Status

Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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AFR22

Identifier Type: -

Identifier Source: secondary_id

IB2005-25

Identifier Type: -

Identifier Source: org_study_id