Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response (AFR22)

This study has been terminated.
Sponsor:
Collaborator:
Novartis
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210119
First received: September 12, 2005
Last updated: July 25, 2013
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Myeloid Leukemia, Chronic
Drug: Imatinib mesylate and zoledronic acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric Phase II Study to Evaluate Feasibility and Efficacy of Association of Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response After One Year of Imatinib Mesylate Monotherapy

Resource links provided by NLM:


Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • To evaluate efficacy on molecular response after 6 months of association treatment

Secondary Outcome Measures:
  • Safety, efficacy after 3 months, antitumoral activity via VEGF and LTgd, period duration of molecular response

Enrollment: 17
Study Start Date: September 2005
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210119

Locations
France
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33076
Centre Hospitalier de Versailles
Le Chesnay, France, 78150
Hôpital Edouard Herriot
Lyon, France, 69437
Hôpital Archet
Nice, France, 06200
Hôpital Saint Louis
Paris, France, 75010
Centre Hospitalier Universitaire de Poitiers
Poitiers, France, 86000
Sponsors and Collaborators
Institut Bergonié
Novartis
Investigators
Principal Investigator: Josy REIFFERS, Pr Institut Bergonié
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00210119     History of Changes
Other Study ID Numbers: IB2005-25, AFR22
Study First Received: September 12, 2005
Last Updated: July 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Chronic myeloid leukemia
imatinib mesylate
zoledronate
molecular response

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Disease Attributes
Pathologic Processes
Zoledronic acid
Diphosphonates
Imatinib
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014