Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib

• Status: Completed
• Trial end date: 2017-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Imatinib Mesylate

Criteria

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).