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

Leukemia, Myeloid, Chronic-Phase Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03239886
• Other study ID #: 15418
• Status: Active, not recruiting
• Phase: N/A
• First received: May 15, 2017
• Last updated: March 22, 2018
• Start date: December 15, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 31, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Other:
• imatinib discontinuation
imatinib discontinuation

Locations

Country	Name	City	State
Brazil	Centro de Pesquisa Clínica da Hematologia do HCFMUSP	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

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