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

NCT03239886 | Unknown

• 1 other identifier: 15418
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Myeloid, Chronic-Phase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of subjects that recover MR3log after imatinib reintroduction

  6 months

• Analysis of immunological profile of all subjects

  24 months

• Safety and tolerability of imatinib discontinuation

  24 months

Study Arms (1)

Discontinuation

EXPERIMENTAL

All subjects will discontinue imatinib

Other: imatinib discontinuation

Interventions

imatinib discontinuation OTHER

imatinib discontinuation

Discontinuation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Centro de Pesquisa Clínica da Hematologia do HCFMUSP

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33517185 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-arm study; all patients will discontinue imatinib (intervention)

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: August 4, 2017
• Study Start: December 15, 2016
• Primary Completion: August 31, 2019
• Study Completion: January 31, 2020
• Last Updated: March 23, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)