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

NCT00210119 | Terminated Phase 2 Results

• 2 other identifiers: IB2005-25AFR22
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 7

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 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.

Conditions

Myeloid Leukemia, Chronic

Keywords

Chronic myeloid leukemia; imatinib mesylate; zoledronate; molecular response

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Molecular Response

  A patient is considered to be in molecular response if at least one of the following conditions is observed : \- a complete molecular response at 6 months defined by PCR negativation tested on twice OR \- reduction of BCR-ABL transcript level \> 2 Log from the start of from initiation of treatment

  6 months

Secondary Outcomes (1)

• Percentage of Participants With a Reduction of BCR-ABL Transcript Level > 4.5 Log From the Start of From Initiation of Treatment

  6 months

Study Arms (1)

Imatinib mesylate

EXPERIMENTAL

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

Drug: Glivec

Interventions

Glivec DRUG

Imatinib mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Institut Bergonié: lead
• Novartis: collaborator

Study Sites (7)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33076, France

Location

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

Bordeaux, 33076, France

Location

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Hôpital Archet

Nice, 06200, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Dr Gabriel Etienne
• Organization: Institut Bergonie

g.etienne@bordeaux.unicancer.fr

Study Officials

• Josy REIFFERS, Pr

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 21, 2005
• Study Start: July 12, 2006
• Primary Completion: September 1, 2007
• Study Completion: March 1, 2009
• Last Updated: November 8, 2021
• Results First Posted: October 28, 2021

Record last verified: 2021-09

Locations

FR (7)