Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia - Full Text View

Sponsored by:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00478985

Purpose

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.

Condition	Intervention
Myeloid Leukemia, Chronic	Behavioral: Imatinib ending

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Multicentric Trial Evaluating the Persistence of the Complete Molecular Remission After Stopping Imatinib in Patients With Chronic Myeloid Leukemia.

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

Evaluation of complete molecular remission persistence as measured by RT-PCR negative for bcr-abl transcripts [ Time Frame: every month during the first year and every two months during the second year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

T lymphocytes differenciation and proliferation analyse / cytokines production analyse [ Time Frame: first visit, M2,M4,M6,M9,M12,M18,M24 ] [ Designated as safety issue: No ]
T lymphocytes apoptosis analyse [ Time Frame: first visit ] [ Designated as safety issue: No ]
Haemogramme analyse [ Time Frame: every months during two years ] [ Designated as safety issue: No ]
Clinical exam [ Time Frame: every three months during the first year and every four months during the second year ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Imatinib treatment ending	Behavioral: Imatinib ending Interruption of the treatment by Imatinib

Detailed Description:

Principal Objective : To evaluate the complete molecular remission persistence after stopping imatinib during six months as measured by RT-PCR negative for bcr-abl transcripts in patients with Chronic Myeloid Leukemia .

Secondary Objective :

To determine clinicals factors associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukemia.
To determine the biologics factors (immunologic and molecular) associated with complete molecular remission before and after stopping imatinib in patients with Chronic Myeloid Leukaemia.
To determine the molecular relapse level after more than six month of persistent complete molecular remission without imatinib.
To determine the complete molecular remission length.
To evaluate medical and economical impact of stopping imatinib treatment.

Study design : multicentric trial

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478985

Contacts

Contact: François-Xavier MAHON, MD	(33) 5 57 57 15 24	francois-xavier.mahon@umr5540.u-bordeaux2.fr
Contact: Philippe ROUSSELOT, MD	(33) 1 39 63 89 09	phrousselot@ch-versailles.fr

Locations

France
University Hospital Bordeaux, Groupe Hospitalier Pellegrin	Recruiting
Bordeaux cedex, France, 33076
Contact: François-Xavier MAHON, MD (33) 5 57 57 15 24 francois-xavier.mahon@umr5540.u-bordeaux2.fr
Principal Investigator: François Xavier MAHON, MD
Hôpital Necker-Enfants Malades	Recruiting
Paris, France, 75743
Contact: Bruno VARET, Pr 01.44.49.52.82 bruno.varet@nck.ap-hop-paris.fr
Principal Investigator: Bruno VARET, MD
Sub-Investigator: Agnès BUZYN, MD
CHR de Metz-Thionville	Recruiting
Metz Cedex 01, France, 57038
Contact: Bernard CHRISTIAN, Dr 03.87.55.32.32 b.christian@chr-metz-thionville.rss.fr
Principal Investigator: Bernard CHRISTIAN, MD
University Hospital Nice	Recruiting
Nice, France, 06202
Contact: Laurence LEGROS, MD 04.92.03.58.41 legros.l@chu-nice.fr
Principal Investigator: Laurence LEGROS, MD
Hôpital André Mignot	Recruiting
Le Chesnay Cedex, France, 78157
Contact: Sylvie CASTAIGNE, MD 01.39.63.89.09 scastaigne@ch-versailles.fr
Principal Investigator: Sylvie CASTAIGNE, MD
Sub-Investigator: Philippe ROUSSELOT, MD
Institut Bergonié	Recruiting
BORDEAUX Cedex, France, 33076
Contact: Josy REIFFERS, MD 05.56.33.33.00. reiffers@bergonie.org
Principal Investigator: Josy REIFFERS, MD
Sub-Investigator: Houchingue EGHBALI, MD
Sub-Investigator: Gabriel ETIENNE, MD
Sub-Investigator: Pierre SOUBEYRAN, MD
Haut Lévêque Hospital	Recruiting
Pessac, France, 33604
Contact: Gerald MARIT, MD 05.57.65.65.11. gerald.marit@chu-bordeaux.fr
Contact: Krimo BOUABDALLAH, MD krimo.bouabdallah@chu-bordeaux.fr
Principal Investigator: Marit Gerald, MD
Sub-Investigator: Krimo BOUABDALLAH, MD
Sub-Investigator: Noël MILPIED, MD
Sub-Investigator: Thibaut LEGUAY, MD
Sub-Investigator: Carine FOUCAUD, MD
Sub-Investigator: Arnaud PIGNEUX, MD
Sub-Investigator: Reza TABRIZI, MD
University Hospital Strasbourg, Hôpital Civil	Recruiting
Strasbourg, France, 67000
Contact: Frédéric MALOISEL, MD 03 88 11 50 98 Frederic.Maloisel@chru-strasbourg.fr
Principal Investigator: Frédéric MALOISEL, MD
Institut Paoli Calmet	Recruiting
Marseille Cedex 9, France, 13273
Contact: Anne CHARBONNIER, MD 04 91 22 37 54 charbonniera@marseille.fnclcc.fr
Contact: Norbert VEY, MD 04 91 22 37 54 veyn@marseille.fnclcc.fr
Principal Investigator: Anne CHARBONNIER, MD
Sub-Investigator: Norbert VEY, MD
Centre hospitalier-service de médecine interne Onco-Hématologique	Recruiting
La Roche sur Yon, France, 85025
Contact: Hervé MAISONNEUVE, MD 02.51.44.61.73/72 herve.maisonneuve@chd-vendee.fr
Principal Investigator: Hervé MAISONNEUVE, MD
Sub-Investigator: Mourad TIAB, MD
Sub-Investigator: Bruno Villemagne, MD
Centre Hospitalier Bretagne Atlantique	Recruiting
Vannes, France, 56 017
Contact: Henry JARDEL, MD 02 97 01 41 45 henry.jardel@ch-bretagne-atlantique.fr
Principal Investigator: Henry JARDEL, MD
Hôpital Edouard Herriot	Recruiting
Lyon, France, 69374
Contact: Mauricette MICHALLET, MD 04 72 11 74 01 mauricette.michallet@chu-lyon.fr
Principal Investigator: Mauricette MICHALLET, MD
Sub-Investigator: Franck NICOLINI, MD
Sub-Investigator: Jacques TRONCY, MD
Sub-Investigator: Xavier THOMAS, MD
Sub-Investigator: Anne THIEBAUT, MD
Principal Investigator: Barraco FIORENZA, MD
Sub-Investigator: Daniela REVESZ, MD
Sub-Investigator: Youcef CHELGOUM, MD
Centre Hospitalier de Nevers	Recruiting
Nevers, France, 58033
Contact: Varet Bruno, Pr. 01 42 19 27 10 bruno.varet@nck.ap-hop-paris.fr
Contact: Isabelle Desmoulins-Louvrier, Dr 01 42 19 27 10 isabelle.desmoulins@ch-nevers.fr
Principal Investigator: Bruno Varet, Pr
Principal Investigator: Isabelle Desmoulins-Louvrier, Dr
CHU de Grenoble	Recruiting
Grenoble, France, 38043
Contact: Jean-Yves Cahn, Pr 04 76 76 56 61 JCahn@chu-grenoble.fr
Principal Investigator: Jean-Yves Cahn, Pr
Sub-Investigator: B Pégourié-Bandelier, Dr
Sub-Investigator: J Mi Wang, Dr
Sub-Investigator: F Garban, Dr
Sub-Investigator: CE Bulabois, Dr
Sub-Investigator: M Heczko, Dr
Sub-Investigator: L Molina, Dr
Sub-Investigator: R Gressin, Dr
Sub-Investigator: S Courby, Dr
Hôpital Bicêtre, AP-HP	Recruiting
LE KREMLIN-BICETRE, France, 94275
Contact: Caroline Besson, Dr 01-45-21-20-16 caroline.besson@bct.aphp.fr
Principal Investigator: Caroline Besson, Dr
Sub-Investigator: Gérard Tertian, Dr
Hôpital Morvan	Recruiting
Brest, France, 29285
Contact: Christian BERTHOU, Pr 02.98.22.34.21 ChristianBerthou@wanadoo.fr
Principal Investigator: Christian BERTHOU, MD
Hôpital Claude Huriez	Recruiting
Lille, France, 59037
Contact: Thierry FACON, Pr 03.20.44.47.08 t-facon@chru-lille.fr
Principal Investigator: Thierry FACON, MD
Sub-Investigator: Marie Pierre NOEL, MD
Sub-Investigator: Ibrahim YAKOUB AGHA, MD
Sub-Investigator: Selim CORM, MD
University Hospital Hôtel-Dieu	Recruiting
Nantes, France, 44035
Contact: Jean Luc HAROUSSEAU, Pr 02.40.08.32.71 jlharousseau@sante.univ-nantes.fr
Principal Investigator: Jean Luc HAROUSSEAU, MD
Sub-Investigator: Vivianne DUBRUILLE, MD
Sub-Investigator: Béatrice MAHE, MD
University Hospital Poitiers	Recruiting
Poitiers, France, 86021
Contact: GUILHOT François, Pr 05.49.44.44.72 f.guilhot@chu-poitiers.fr
Contact: Lydia ROY, Dr 05.49.44.44.72 l.roy@chu-poitiers.fr
Principal Investigator: François GUILHOT, MD
University Hospital Toulouse, Purpan	Recruiting
Toulouse, France, 31059
Contact: Françoise RIGAL-HUGUET, Dr 05.61.77.20.78 huguet.f@chu-toulouse.fr
Principal Investigator: Françoise RIGAL-HUGUET, MD
Sub-Investigator: Guy LAURENT, MD
Sub-Investigator: Christian RECHER, MD
Sub-Investigator: Christiane NOUVEL, MD
Sub-Investigator: Anne HUYN, MD
Sub-Investigator: Loïc YSEBAERT, MD
Sub-Investigator: Marianne ARQUIER, MD
University Hospital Brabois	Recruiting
VANDOEUVRE LES NANCY, France, 54500
Contact: Agnès-Paule GUERCI, Dr 03.83.15.32.82 a.guerci@chu-nancy.fr
Principal Investigator: Agnès-Paule GUERCI, MD
France, Angers
University Hospital Angers	Recruiting
Angers Cedex 01, Angers, France, 49033
Contact: Martine GARDEMBAS-PAIN, Dr 02.41.35.47.05 MaGardembas@chu-angers.fr
Principal Investigator: Martine GARDEMBAS-PAIN, MD
Sub-Investigator: Truchan GRACYK, MD
Sub-Investigator: Hunault BERGER, MD
Sub-Investigator: IFRAH, MD
Sub-Investigator: FOUSSARD, MD
Sub-Investigator: GUARDIOLAT, MD
Sub-Investigator: FRANCOIS, MD
Sub-Investigator: DIB, MD
Sub-Investigator: BOYER, MD
Sub-Investigator: MOLES, MD
France, Créteil
Hôpital Henri-Mondor	Recruiting
CRETEIL, Créteil, France, 94000
Contact: Michel TULLIEZ, Pr 01.49.81.28.78 michel.tulliez@hmn.ap-hop-paris.fr
Principal Investigator: Michel TULLIEZ, MD
France, Paris
Hôpital Saint Louis	Recruiting
PARIS Cedex, Paris, France, 75475
Contact: Philippe ROUSSELOT, Dr 01.42.49.96.49 philippe.rousselot@chu-stlouis.fr
Principal Investigator: Philippe ROUSSELOT, MD
Principal Investigator: Delphine REA, MD

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator:

François-Xavier MAHON, MD

University Hospital Bordeaux, France

Responsible Party:	University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers:	CHUBX 2006/06
Study First Received:	May 23, 2007
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00478985 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency