Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia

NCT00478985 | Completed DMC

• 1 other identifier: CHUBX 2006/06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 24

Brief Summary

The first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with Chronic Myeloid Leukemia after stopping imatinib treatment (determine by Reverse Transcription real-time Polymerase Chain Reaction (RT-PCR) negative for bcr-abl transcripts). The second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.

Conditions

Myeloid Leukemia, Chronic

Keywords

Leukemia; Adult Chronic; Myeloid

Outcome Measures

Primary Outcomes (1)

• Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts

  Every month during the first year and every two months during the second year

Secondary Outcomes (4)

• T lymphocytes differenciation and proliferation analyse / cytokines production analyse

  first visit, M2,M4,M6,M9,M12,M18,M24

• T lymphocytes apoptosis analyse

  first visit

• Haemogramme analyse

  every months during two years

• Clinical exam

  every three months during the first year and every four months during the second year

Study Arms (1)

1

EXPERIMENTAL

Imatinib treatment ending

Behavioral: Imatinib ending

Interventions

Imatinib ending BEHAVIORAL

Interruption of the treatment by Imatinib

1

Eligibility Criteria

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

You may qualify if:

• Patients must have reached their 18th birthday
• Women of childbearing potential must agree to use effective methods of contraception
• Patients must be affiliated to a social security regime
• Patients must have received imatinib therapy for at least 36 months.
• Patients must be in complete molecular remission during at least two consecutive years with at least five RT-PCR negative measures for bcr-abl transcripts.
• Patients must be HIV, HCV and HBV negatives
• Patients who have molecular follow-up realized in accordance with international recommendations
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

You may not qualify if:

• Patients who are protected by the law. Patients who are unable to give their consent to participate to the study.
• Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping imatinib. Patients who have pathologies or treatments which able to interfere with immunologic study (excepted IFN α):
• Corticosteroids or other immuno suppressors Other concomitant malign pathology treated by chemotherapy or radiotherapy Previous or programmed Haematopoietic Stem Cell allogreffe

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (24)

University Hospital Angers

Angers, Angers, 49033, France

Location

Hôpital Morvan

Brest, Brest, 29285, France

Location

Hôpital Henri-Mondor

Créteil, Créteil, 94000, France

Location

Hôpital Claude Huriez

Lille, Lille, 59037, France

Location

University Hospital Hôtel-Dieu

Nantes, Nantes, 44035, France

Location

Hôpital Saint Louis

Paris, Paris, 75475, France

Location

University Hospital Poitiers

Poitiers, Poitiers, 86021, France

Location

University Hospital Toulouse, Purpan

Toulouse, Toulouse, 31059, France

Location

University Hospital Brabois

Vandœuvre-lès-Nancy, Vandoeuvre Les Nancy, 54500, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

University Hospital Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Centre hospitalier-service de médecine interne Onco-Hématologique

La Roche-sur-Yon, 85025, France

Location

Hôpital André Mignot

Le Chesnay, 78157, France

Location

Hôpital Bicêtre, AP-HP

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital Edouard Herriot

Lyon, 69374, France

Location

Institut Paoli Calmet

Marseille, 13273, France

Location

CHR de Metz-Thionville

Metz, 57038, France

Location

Centre Hospitalier de Nevers

Nevers, 58033, France

Location

University Hospital Nice

Nice, 06202, France

Location

Hôpital Necker-Enfants Malades

Paris, 75743, France

Location

Haut Lévêque Hospital

Pessac, 33604, France

Location

University Hospital Strasbourg, Hôpital Civil

Strasbourg, 67000, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, 56 017, France

Location

Related Publications (3)

• Mahon FX, Dulucq S, Rea D, Nicolini FE, Rigal-Huguet F, Machova Polakova K, Dubruille V, Noel MP, Ianotto JC, Villemagne B, Cayssials E, Park S, Rousselot P, Etienne G. Extended long-term follow-up and the survival of Stop Imatinib study. Blood Neoplasia. 2025 Oct 27;3(1):100177. doi: 10.1016/j.bneo.2025.100177. eCollection 2026 Feb.

  PMID: 41574312 DERIVED

• Rea D, Henry G, Khaznadar Z, Etienne G, Guilhot F, Nicolini F, Guilhot J, Rousselot P, Huguet F, Legros L, Gardembas M, Dubruille V, Guerci-Bresler A, Charbonnier A, Maloisel F, Ianotto JC, Villemagne B, Mahon FX, Moins-Teisserenc H, Dulphy N, Toubert A. Natural killer-cell counts are associated with molecular relapse-free survival after imatinib discontinuation in chronic myeloid leukemia: the IMMUNOSTIM study. Haematologica. 2017 Aug;102(8):1368-1377. doi: 10.3324/haematol.2017.165001. Epub 2017 May 18.

  PMID: 28522576 DERIVED

• Mahon FX, Rea D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Francais des Leucemies Myeloides Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.

  PMID: 20965785 DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; 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; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• François-Xavier MAHON, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 25, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 2, 2013

Record last verified: 2013-07

Locations

FR (24)