Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase
NCT ID: NCT05926128
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2019-02-01
2025-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CML patient TKI discontinuation study
Treatment free remission in patients with chronic myeloid leukemia in chronic phase who achieved deep molecular response with tyrosine kinase inhibitors
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment with a scheduled molecular monitoring until month 24.
Interventions
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Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment with a scheduled molecular monitoring until month 24.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Age ≥ 18 years
4. ≥ 4 years of treatment with imatinib, nilotinib or dasatinib.
5. Achievement of MR 4.5 in a standardized laboratory (BCR-ABL1 IS ≤ 0.0032%).
6. Evidence of MR 4.5 sustained for ≥ 2 years, as documented in at least 4 tests performed at least 3 months apart.
7. Evidence of typical quantifiable BCR-ABL1 transcript (b3a2 \[e14a2\] and / or b2a2 \[e13a2\], typical isoforms of p210).
Exclusion Criteria
2. Patients with failure to any TKI at any time.
3. Patients who presented accelerated phase or CML in blast crisis at any time.
4. Patients with atypical transcript not quantifiable by RT qPCR
5. BCR-ABL mutation detected at any time during the course of the resistant disease
18 Years
99 Years
ALL
No
Sponsors
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Fundaleu
OTHER
Responsible Party
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Carolina Pavlovsky
Chief of Clinical Research Area
Locations
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FUNDALEU
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AST2018
Identifier Type: OTHER
Identifier Source: secondary_id
Argentina Stop Trial
Identifier Type: -
Identifier Source: org_study_id
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