Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response (AFR22)
This study has been terminated.
Sponsor:
Institut Bergonié
Collaborator:
Novartis
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210119
First received: September 12, 2005
Last updated: December 29, 2011
Last verified: October 2007
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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
| Estimated Enrollment: | 37 |
| 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: | December 29, 2011 |
| 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 May 21, 2013