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

March 22, 2018 updated by: University of Sao Paulo General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil
        • Centro de Pesquisa Clínica da Hematologia do HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Discontinuation
All subjects will discontinue imatinib
Other: imatinib discontinuation
imatinib discontinuation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
Analysis of immunological profile of all subjects
Time Frame: 24 months
Study of lymphocytes population by flow cytometry, including NK and T population
24 months
Safety and tolerability of imatinib discontinuation
Time Frame: 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 15, 2016

Primary Completion (ANTICIPATED)

August 31, 2019

Study Completion (ANTICIPATED)

January 31, 2020

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

August 1, 2017

First Posted (ACTUAL)

August 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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