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

Primary Purpose

Leukemia, Myeloid, Chronic-Phase

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
imatinib discontinuation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Chronic-Phase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centro de Pesquisa Clínica da Hematologia do HCFMUSP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Discontinuation

Arm Description

All subjects will discontinue imatinib

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Analysis of immunological profile of all subjects
Study of lymphocytes population by flow cytometry, including NK and T population
Safety and tolerability of imatinib discontinuation
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Full Information

First Posted
May 15, 2017
Last Updated
March 22, 2018
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03239886
Brief Title
Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log
Official Title
Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
January 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Chronic-Phase

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-arm study; all patients will discontinue imatinib (intervention)
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Discontinuation
Arm Type
Experimental
Arm Description
All subjects will discontinue imatinib
Intervention Type
Other
Intervention Name(s)
imatinib discontinuation
Intervention Description
imatinib discontinuation
Primary Outcome Measure Information:
Title
Number of subjects that remain with RM3log after imatinib discontinuation
Description
Number of subjects that sustain BCR-ABL level below 0,1% after 24 months of follow up.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of subjects that recover MR3log after imatinib reintroduction
Description
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
Title
Analysis of immunological profile of all subjects
Description
Study of lymphocytes population by flow cytometry, including NK and T population
Time Frame
24 months
Title
Safety and tolerability of imatinib discontinuation
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Centro de Pesquisa Clínica da Hematologia do HCFMUSP
City
São Paulo
State/Province
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33517185
Citation
Seguro FS, Maciel FVR, Santos FM, Abdo ANR, Pereira TDM, Nardinelli L, Rocha V, Bendit I. MR 4log and low levels of NK cells are associated with higher molecular relapse after imatinib discontinuation: Results of a prospective trial. Leuk Res. 2021 Feb;101:106516. doi: 10.1016/j.leukres.2021.106516. Epub 2021 Jan 21.
Results Reference
derived

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

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