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

University of Sao Paulo General Hospital30 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

imatinib discontinuationOTHER

imatinib discontinuation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Centro de Pesquisa Clínica da Hematologia do HCFMUSP

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

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

Time frame: 6 months

Analysis of immunological profile of all subjects

Study of lymphocytes population by flow cytometry, including NK and T population

Time frame: 24 months

Safety and tolerability of imatinib discontinuation

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame: 24 months

Data from ClinicalTrials.gov

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