Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM-FU)

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?

Study Overview

• Status: Completed
• Conditions: Chronic Myeloid Leukemia
• Intervention / Treatment: Behavioral: Interruption of the treatment by Imatinib

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• France
  • Angers, France, 49033
    • CHU d'Angers
  • Bordeaux, France, 33076
    • Institut Bergonie
  • Bordeaux, France, 33604
    • CHU de Bordeaux - Haut-Lévêque
  • Brest, France, 29285
    • Hopital Morvan
  • Creteil, France, 94000
    • Hôpital Henri-Mondor
  • Grenoble, France, 38043
    • Pôle de cancérologie
  • La Roche Sur Yon, France, 85025
    • Centre Hospitalier de La Roche sur Yon
  • Le Chesnay, France, 78157
    • Centre Hospitalier De Versailles
  • Lille, France, 59037
    • Hôpital Claude Huriez
  • Lyon, France, 69374
    • Hôpital Edouard Herriot
  • Marseille, France, 13273
    • Institut Paoli Calmette
  • Nantes, France, 44035
    • CHU Hotel-Dieu
  • Nice, France, 06202
    • CHU de Nice
  • Paris, France, 75475
    • Hopital Saint Louis
  • Paris, France, 75743
    • Hôpital Necker-Enfants Malades
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Strasbourg, France, 67000
    • Hôpital Civil
  • Toulouse, France, 31059
    • Hopital Purpan
  • Vandoeuvre les Nancy, France, 54500
    • Chu Brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients included in the STIM1 protocol with persistence of the Complete Molecular Remission after Stopping Imatinib Chronic Myeloid Leukemia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Imatinib treatment ending; Interruption of the treatment by Imatinib	Behavioral: Interruption of the treatment by Imatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Evaluation of rate of molecular relapse after imatinib discontinuation	up to five years
Evaluation of duration of deep molecular response after stopping imatinib	up to five years
Status dead or alive for each patient	up to five years

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2013
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: CHUBX 2012/06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO