Back to resultsStudy of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase (AST)
Primary Purpose
CML
Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment
Sponsored by
About this trial
This is an interventional treatment trial for CML focused on measuring DISCONTINUATION
Eligibility Criteria
Inclusion criteria: Signed Informed consent. Patients with a diagnosis of CML BCR-ABL positive in CP treated with approved TKI (Imatinib, Nilotinib or Dasatinib) in 1st line or in 2nd line due to intolerance to the 1st line or in 2nd line due to the lack of deep MR with 1st line TKI, which never presented criteria for treatment failure. Age ≥ 18 years ≥ 4 years of treatment with imatinib, nilotinib or dasatinib. Achievement of MR 4.5 in a standardized laboratory (BCR-ABL1 IS ≤ 0.0032%). Evidence of MR 4.5 sustained for ≥ 2 years, as documented in at least 4 tests performed at least 3 months apart. Evidence of typical quantifiable BCR-ABL1 transcript (b3a2 [e14a2] and / or b2a2 [e13a2], typical isoforms of p210). Exclusion criteria: Patients who previously discontinued TKI and demonstrated recurrence of the disease. Patients with failure to any TKI at any time. Patients who presented accelerated phase or CML in blast crisis at any time. Patients with atypical transcript not quantifiable by RT qPCR BCR-ABL mutation detected at any time during the course of the resistant disease
Sites / Locations
- FUNDALEURecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CML patient TKI discontinuation study
Arm Description
Treatment free remission in patients with chronic myeloid leukemia in chronic phase who achieved deep molecular response with tyrosine kinase inhibitors
Outcomes
Primary Outcome Measures
Molecular relapse free survival during 24 months
Molecular relapse free survival, defined as the time from the start of TKI interruption until the loss of the MMR.
RQ PCR (IS) >0.1% BCR ABL will be considered as loss of MMR
Secondary Outcome Measures
Treatment-free survival during 24 months
Treatment-free survival , defined as the time from the start of TKI interruption to the restart of the TKI.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05926128
Brief Title
Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase
Acronym
AST
Official Title
Prospective Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Achieved Deep Molecular Response With Tyrosine Kinase Inhibitors in Real Life Setting in Argentina - (Argentine Stop Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundaleu
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
The principal aim of this study is to evaluate complete molecular remission in patients with chronic myeloid leukemia (CML) in deep molecular response after stopping tyrosine kinase inhibitor (TKI) treatment. The second aim is to characterize the immunological status of patients with CML at the time of TKI interruption and then at 3 months after the interruption.
Detailed Description
ARGENTINA STOP TRIAL is a multicentre, open-label, uncontrolled trial to estimate the persistence of molecular remission in patients with chronic phase Chronic Myeloid Leukemia (CML) in Deep Molecular Response after stopping Tyrosine Kinase Inhibitor (TKI)
Primary Objective:
- To identify the proportion of patients who continue on Major Molecular Response after discontinuing treatment with TKI.
Secondary objectives:
To characterize the immunological status of patients with CML at the time of interruption and then at 3 and 12 months after the interruption.
Tertiary objective: To evaluate the pharmacoeconomic impact of interrupting the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CML
Keywords
DISCONTINUATION
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
multicentre, open-label, uncontrolled trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CML patient TKI discontinuation study
Arm Type
Other
Arm Description
Treatment free remission in patients with chronic myeloid leukemia in chronic phase who achieved deep molecular response with tyrosine kinase inhibitors
Intervention Type
Drug
Intervention Name(s)
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment
Intervention Description
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment with a scheduled molecular monitoring until month 24.
Primary Outcome Measure Information:
Title
Molecular relapse free survival during 24 months
Description
Molecular relapse free survival, defined as the time from the start of TKI interruption until the loss of the MMR.
RQ PCR (IS) >0.1% BCR ABL will be considered as loss of MMR
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Treatment-free survival during 24 months
Description
Treatment-free survival , defined as the time from the start of TKI interruption to the restart of the TKI.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Overall survival during 24 months
Description
Overall survival, defined from the day of TKI interruption until date of death, date of last contact or loss of follow-up.
Time Frame
24 months
Title
Pharmacoeconomic analysis during 24 months
Description
Calculate the total saving of the included patients un US dollars, considering the costs of TKIs, PCRs performing and medical visits,
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Signed Informed consent.
Patients with a diagnosis of CML BCR-ABL positive in CP treated with approved TKI (Imatinib, Nilotinib or Dasatinib) in 1st line or in 2nd line due to intolerance to the 1st line or in 2nd line due to the lack of deep MR with 1st line TKI, which never presented criteria for treatment failure.
Age ≥ 18 years
≥ 4 years of treatment with imatinib, nilotinib or dasatinib.
Achievement of MR 4.5 in a standardized laboratory (BCR-ABL1 IS ≤ 0.0032%).
Evidence of MR 4.5 sustained for ≥ 2 years, as documented in at least 4 tests performed at least 3 months apart.
Evidence of typical quantifiable BCR-ABL1 transcript (b3a2 [e14a2] and / or b2a2 [e13a2], typical isoforms of p210).
Exclusion criteria:
Patients who previously discontinued TKI and demonstrated recurrence of the disease.
Patients with failure to any TKI at any time.
Patients who presented accelerated phase or CML in blast crisis at any time.
Patients with atypical transcript not quantifiable by RT qPCR
BCR-ABL mutation detected at any time during the course of the resistant disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Pavlovsky, MD
Phone
+541148771070
Email
cpavlovsky@fundaleu.org.ar
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana Juni
Phone
+541148771070
Email
mjuni@fundaleu.org.ar
Facility Information:
Facility Name
FUNDALEU
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
1114
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Pavlovsky, MD
Phone
+541148771070
Email
cpavlovsky@fundaleu.org.ar
First Name & Middle Initial & Last Name & Degree
Mariana Juni
Phone
+541148771070
Email
mjuni@fundaleu.org.ar
First Name & Middle Initial & Last Name & Degree
Carolina Pavlovsky, MD
First Name & Middle Initial & Last Name & Degree
Beatriz Moiraghi, MD
First Name & Middle Initial & Last Name & Degree
Ana I Varela, MD
First Name & Middle Initial & Last Name & Degree
Michele Bianchini
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase
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