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This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. To be eligible for this protocol, the subject must have received imatinib as first line regiment for at least 3 years with sustained molecular response of 4log (RM4log) or higher for one year.
Patients will be followed for 2 years, with molecular monitoring, every month in the first year and then every 2 months. Imatinib will be restarted if the major molecular response (RM3log) is lost during the study or if the subject withdraw the informed consenting.
The primary objective is to measure the number of subject that sustain the major molecular response (RM3log or BCR-ABL level below 0.1%) after 2 years of follow-up.
BCR: breakpoint cluster region
ABL: abelson murine leukemia
RM3log: major molecular response, BCR-ABL level below 0.1% (IS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discontinuation | Experimental | All subjects will discontinue imatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imatinib discontinuation | Other | imatinib discontinuation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects that remain with RM3log after imatinib discontinuation | Number of subjects that sustain BCR-ABL level below 0,1% after 24 months of follow up. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects that recover MR3log after imatinib reintroduction | In the population that do not sustain BCR-ABL below 0,1% during the study, the time to recover the response after imatinib reintroduction will be measured | 6 months |
| Analysis of immunological profile of all subjects |
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Inclusion Criteria:
Exclusion Criteria:
IS: International Scale
MR4log: molecular response of 4log or <0,1% (IS)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Pesquisa ClÃnica da Hematologia do HCFMUSP | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33517185 | Derived | Seguro FS, Maciel FVR, Santos FM, Abdo ANR, Pereira TDM, Nardinelli L, Rocha V, Bendit I. MR 4log and low levels of NK cells are associated with higher molecular relapse after imatinib discontinuation: Results of a prospective trial. Leuk Res. 2021 Feb;101:106516. doi: 10.1016/j.leukres.2021.106516. Epub 2021 Jan 21. |
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| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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single-arm study; all patients will discontinue imatinib (intervention)
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Study of lymphocytes population by flow cytometry, including NK and T population |
| 24 months |
| Safety and tolerability of imatinib discontinuation | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 24 months |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |