This trial is active, not recruiting.

Condition chronic myeloid leukemia
Treatment interruption of the treatment by imatinib
Sponsor University Hospital, Bordeaux
Start date April 2013
End date April 2019
Trial size 98 participants
Trial identifier NCT02896829, CHUBX 2012/06


It's an observational study based on 98 patients included in the STIM trial to extend the monitoring of patients and to have molecular and clinical data, with long follow up. Are there late relapses? What has become patients who relapsed during STIM trial and restarted TKI (inhibitor tyrosine kinase) treatment?

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective
Interruption of the treatment by Imatinib
interruption of the treatment by imatinib

Primary Outcomes

Assessment of the molecular status (BCR-ABL1 quantification by RT-qPCR) in the STIM1 population who stopped or restart a treatment by tyrosine kinase inhibitor (TKI)
time frame: up to five years

Secondary Outcomes

Evaluation of rate of molecular relapse after imatinib discontinuation
time frame: up to five years
Evaluation of duration of deep molecular response after stopping imatinib
time frame: up to five years
Status dead or alive for each patient
time frame: up to five years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - The patients should have been included in the STIM1 Study CHUBX 2006/06 (NCT00478985) Exclusion Criteria: - The patients not included or discharged prematurely from the STIM1 Study can not participate to the study

Additional Information

Official title Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
Description Chronic myeloid leukemia (CML) is an hematopoietic stem cell disorder in which a t (9;22) (q34;q11) reciprocal chromosomal translocation gives rise to Philadelphia chromosome (Ph) and generates the BCR-ABL1 fusion gene encoding a constitutively activated protein tyrosine kinases (PTK). Tyrosine kinase Inibitors (TKIs) such as imatinib, by blocking BCR-ABL1 kinase activity, selectively eradicate CML cells and induce durable responses and prolong survival. CML patients treated with TKI are monitored by BCR-ABL1 RT-qPCR (Reverse Transcription real-time quantitative Polymerase Chain Reaction) performed from peripheral blood samples. A first multicenter study entitled STIM trial demonstrated that imatinib could be safely discontinued in patients with complete molecular remission (CMR) for at least 2 years (undetectable BCR-ABL1 transcript by RT-qPCR). Around 40% of these patients remain in a prolonged treatment-free remission (TFR) after treatment cessation. All molecular relapsing patients were sensitive when imatinib was re-challenged. The purpose of this STIM-FU study is to follow all the patients included in the STIM trial in order to evaluate their molecular status, vital status and ongoing treatment in patient with a first molecular relapse. This long term follow up will allow us to predict if a constant long term control of the disease is possible and to better define the clinical and biological CML-related factors predictive for a molecular relapse after TKI discontinuation.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.