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

Not Applicable

• Conditions: Leukemia, Myeloid, Chronic-Phase
• Interventions: Other: imatinib discontinuation

• Registration Number: NCT03239886
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-12-15
• Status Verified: 2017-05
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-04
• Last Update Submitted: 2018-03-22
• Last Update Posted: 2018-03-23
• Primary Completion: 2019-08-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Discontinuation	imatinib discontinuation	All subjects will discontinue imatinib

Primary Outcome Measures

Name	Time	Method
Number of subjects that remain with RM3log after imatinib discontinuation	24 months	Number of subjects that sustain BCR-ABL level below 0,1% after 24 months of follow up.

Secondary Outcome Measures

Name	Time	Method
Number of subjects that recover MR3log after imatinib reintroduction	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	24 months	Study of lymphocytes population by flow cytometry, including NK and T population
Safety and tolerability of imatinib discontinuation	24 months	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Trial Locations

Locations (1)

Centro de Pesquisa Clínica da Hematologia do HCFMUSP; 🇧🇷 São Paulo, Sao Paulo, Brazil