Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log
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|ClinicalTrials.gov Identifier: NCT03239886|
Recruitment Status : Active, not recruiting
First Posted : August 4, 2017
Last Update Posted : March 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Chronic-Phase||Other: imatinib discontinuation||Not Applicable|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single-arm study; all patients will discontinue imatinib (intervention)|
|Masking:||None (Open Label)|
|Official Title:||Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log|
|Actual Study Start Date :||December 15, 2016|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||January 31, 2020|
All subjects will discontinue imatinib
Other: imatinib discontinuation
- Number of subjects that remain with RM3log after imatinib discontinuation [ Time Frame: 24 months ]Number of subjects that sustain BCR-ABL level below 0,1% after 24 months of follow up.
- Number of subjects that recover MR3log after imatinib reintroduction [ Time Frame: 6 months ]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
- Analysis of immunological profile of all subjects [ Time Frame: 24 months ]Study of lymphocytes population by flow cytometry, including NK and T population
- Safety and tolerability of imatinib discontinuation [ Time Frame: 24 months ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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 ClinicalTrials.gov identifier (NCT number): NCT03239886
|Centro de Pesquisa Clínica da Hematologia do HCFMUSP|
|São Paulo, Sao Paulo, Brazil|