ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2420 for:    SUSTAIN 4

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03239886
Recruitment Status : Active, not recruiting
First Posted : August 4, 2017
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Chronic-Phase Other: imatinib discontinuation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single-arm study; all patients will discontinue imatinib (intervention)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log
Actual Study Start Date : December 15, 2016
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : January 31, 2020


Arm Intervention/treatment
Experimental: Discontinuation
All subjects will discontinue imatinib
Other: imatinib discontinuation
imatinib discontinuation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Analysis of immunological profile of all subjects [ Time Frame: 24 months ]
    Study of lymphocytes population by flow cytometry, including NK and T population

  3. Safety and tolerability of imatinib discontinuation [ Time Frame: 24 months ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239886


Locations
Brazil
Centro de Pesquisa Clínica da Hematologia do HCFMUSP
São Paulo, Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03239886     History of Changes
Other Study ID Numbers: 15418
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action