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Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib (STIM 2)

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ClinicalTrials.gov Identifier: NCT01343173
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE March 23, 2011
First Posted Date  ICMJE April 27, 2011
Last Update Posted Date March 13, 2018
Actual Study Start Date  ICMJE April 6, 2011
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
Rate of molecular relapse defined by the rate of patients having a significant increasing of BCR-ABL transcript. [ Time Frame: Every months during two years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
  • Overall survival [ Time Frame: after two years ]
    Number of patients alive or died will be measured
  • Clinical and biological profile of patient with complete molecular remission persistence [ Time Frame: after two years ]
    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.
  • Treatment costs according to days without imatinib. [ Time Frame: after two years ]
  • Event-free survival [ Time Frame: after two years ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib
Official Title  ICMJE Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Myeloid Leukaemia
Intervention  ICMJE Drug: Imatinib stop
To stop imatinib after inclusion.
Study Arms  ICMJE Experimental: Patients
Intervention: Drug: Imatinib stop
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 29, 2014)
220
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2011)
200
Actual Study Completion Date  ICMJE May 30, 2017
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01343173
Other Study ID Numbers  ICMJE CHUBX 2010/25
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: François-Xavier MAHON, Pr University Hospital Bordeaux, France
PRS Account University Hospital, Bordeaux
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP