Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia

Chronic Myeloid Leukemia Clinical Trial

— STIM-FU  

Official title:

Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896829
• Other study ID #: CHUBX 2012/06
• Status: Completed
• Start date: April 3, 2013
• Est. completion date: April 2019

Study information

• Verified date: June 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Behavioral:
• Interruption of the treatment by Imatinib

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHU de Bordeaux - Haut-Lévêque	Bordeaux
France	Institut Bergonié	Bordeaux
France	Hôpital Morvan	Brest
France	Hôpital Henri-Mondor	Creteil
France	Pôle de cancérologie	Grenoble
France	Centre Hospitalier de La Roche Sur Yon	La Roche Sur Yon
France	Centre Hospitalier de Versailles	Le Chesnay
France	Hôpital Claude Huriez	Lille
France	Hôpital Edouard Herriot	Lyon
France	Institut Paoli Calmette	Marseille
France	CHU Hôtel-Dieu	Nantes
France	CHU de Nice	Nice
France	Hôpital Necker-Enfants Malades	Paris
France	Hôpital Saint Louis	Paris
France	CHU de Poitiers	Poitiers
France	Hôpital Civil	Strasbourg
France	Hôpital Purpan	Toulouse
France	CHU Brabois	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		up to five years
Secondary	Evaluation of rate of molecular relapse after imatinib discontinuation		up to five years
Secondary	Evaluation of duration of deep molecular response after stopping imatinib		up to five years
Secondary	Status dead or alive for each patient		up to five years