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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01343173
Other study ID # CHUBX 2010/25
Secondary ID
Status Completed
Phase N/A
First received March 23, 2011
Last updated March 12, 2018
Start date April 6, 2011
Est. completion date May 30, 2017

Study information

Verified date March 2018
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials.

Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. The objectives of this study are to determine the rate of patients without a molecular relapse and so the rate of molecular relapse, to determine and to seek for clinical and biological CML-related factors predictive for a molecular relapse after imatinib discontinuation. These objectives require to increase the number of study patients to be enrolled for accurate statistical considerations. It will allow to predict which patients have to be proposed for discontinuation without risk of molecular relapse and to select the patients who need to continue or reinforce the treatment to achieve a complete long term eradication of the disease.


Description:

The gold standard for the treatment of chronic myeloid leukaemia (CML) is Imatinib, the first tyrosine inhibitor (TKI) of BCR-ABL. Imatinib specifically targets the BCR-ABL tyrosine kinase encoded by the BCR-ABL fusion gene, the molecular hallmark of CML. Regular monitoring of BCR-ABL transcript levels by quantitative RT-PCR is of key importance for the assessment of treatment response to imatinib.

Over time, an increasing proportion of imatinib-treated patients obtain a complete molecular response (CMR), defined as an undetectable molecular residual disease. In a previous study, STIM trial (PHRC 2006, stop Imatinib), 100 patients were included. The preliminary analysis among 69 patients having a median follow up of 21 months shows that the probability to maintain the CMR at 12 months is 45%. Our goal is actually to include up to 200 patients and then let the STIM opened during 3 years in a way to determine the predictive factors of the molecular relapse Discontinuation of treatment is proposed after checking selection criteria and signing informed consent. The assessment of BCR-ABL in peripheral blood by quantitative RT-PCR is performed every month during the first year then every two months second year then every three months during 3 years.

The molecular relapse after imatinib discontinuation is defined by positive PCR for BCR-ABL two times using RTQ-PCR with increasing of the transcript on two following assessment and or a value> 0.1% i.e. lost of MMR. In case of molecular relapse it is recommended to re-challenge an imatinib treatment. According to our experience the 50 patients well documented who re challenged the treatment were sensitive again. The treatment of molecular relapse by second generation tyrosine kinase inhibitors (dasatinib or nilotinib) will possible in the current trial. It is important for all the French patients to be included in a national trial to avoid discontinuation without evaluation.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date May 30, 2017
Est. primary completion date May 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years and older.

- Chronic myeloid leukaemia in chronic or accelerated phase under treatment with imatinib for at least 3 years.

- Complete molecular remission under treatment with imatinib for at least 2 years.

- HIV serology negative and absence of chronic hepatitis B or C.

- Molecular monitoring according to the international recommendations before the beginning of the study

- For the women old enough to procreate, method of effective contraception

- All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

Exclusion Criteria:

- Under 18 years old.

- Pregnant at the inclusion's time.

- Hospitalized patients without consent.

- Adults under law protection or without ability to assent.

- Previous or planned allogeneic stem cell transplantation.

- HIV serology positive or chronic hepatitis B or C.

- Interfering treatment (corticosteroids, immunosuppressors, chemotherapy, radiotherapy).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Imatinib stop
To stop imatinib after inclusion.

Locations

Country Name City State
France University Hospital Angers Angers
France CH Annecy Annecy
France CHU Bensançon Besançon
France Institut Bergonié Bordeaux
France Hôpital Morvan Brest
France CHU Caen Caen
France Hôpitaux civils de Colmar Colmar
France CH Sud Francilien Corbeil-Essonnes
France Hôpital Henri-Mondor Creteil
France CHU Grenoble Grenoble
France Centre Hospitalier - La Roche sur Yon La Roche Sur Yon
France Lille University hospital - Hôpital Claude Huriez Lille
France CHU Dupuytren Limoges
France Hôpital Edouard Herriot Lyon
France Institut Paoli Calmette Marseille
France CHU Hôtel-Dieu Nantes
France Centre Hospitalier de Nevers Nevers
France CHU de Nice - Hôpital Archet 1 Nice
France Hôpital Necker-Enfants Malades Paris
France Hôpital Saint Louis Paris
France University Hospital Bordeaux, Hôpital du Haut Lévêque Pessac
France University Hospital Poitiers - Hôpital Jean Bernard Poitiers
France Hôpital Pontchaillou Rennes
France Centre Henri Becquerel Rouen
France CH Yves Le Foll Saint Brieuc
France CH Régional de l'ILE DE LA REUNION/ Groupe Hospitalier Sud Saint Pierre
France CHR La Réunion Saint-Denis
France Hôpital Purpan Toulouse
France CH Valence Valence
France C.H.U. Brabois Vandoeuvre Les Nancy
France CH Bretagne Atlantique Vannes
France Centre Hospitalier de Versailles - Hôpital André Mignot Versailles

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of molecular relapse defined by the rate of patients having a significant increasing of BCR-ABL transcript. Every months during two years
Secondary Overall survival Number of patients alive or died will be measured after two years
Secondary Clinical and biological profile of patient with complete molecular remission persistence The relevant clinical and biological factors which could be predictive of the the complete molecular remission persistence will be measured by dosage in the blood. after two years
Secondary Treatment costs according to days without imatinib. after two years
Secondary Event-free survival All adverse events will be reported to know what kind of adverse events occured to patients without treatment, number of patients with adverse events and in particular number of patients with lost of complete molecular remission. after two years
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