Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-15

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Leukemia, Myeloid, Chronic-Phase

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single-arm study; all patients will discontinue imatinib (intervention)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Discontinuation

All subjects will discontinue imatinib

Group Type EXPERIMENTAL

imatinib discontinuation

Intervention Type OTHER

imatinib discontinuation

Interventions

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imatinib discontinuation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic myeloid leukemia chronic-phase, defined by the World Health Organization criteria
* Treatment with imatinib for at least 36 months
* BCR-ABL levels below 0,01% (IS) or MR4log in the last 12 months

Exclusion Criteria

* Previous allogeneic stem cell transplantation
* Previous treatment with dasatinib, nilotinib, bosutinib or ponatinib
* Imatinib dose escalation at any time, due to loss or inadequate response
* BCR-ABL mutation

IS: International Scale

MR4log: molecular response of 4log or \<0,1% (IS)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No