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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01343173
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : March 13, 2018
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukaemia Drug: Imatinib stop Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib
Actual Study Start Date : April 6, 2011
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 30, 2017

Arm Intervention/treatment
Experimental: Patients Drug: Imatinib stop
To stop imatinib after inclusion.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: after two years ]
    Number of patients alive or died will be measured

  2. 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.

  3. Treatment costs according to days without imatinib. [ Time Frame: after two years ]
  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01343173

Show Show 32 study locations
Sponsors and Collaborators
University Hospital, Bordeaux
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Principal Investigator: François-Xavier MAHON, Pr University Hospital Bordeaux, France
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Responsible Party: University Hospital, Bordeaux Identifier: NCT01343173    
Other Study ID Numbers: CHUBX 2010/25
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Keywords provided by University Hospital, Bordeaux:
Adult Chronic
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action