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Trial Title:
Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase
NCT ID:
NCT05926128
Condition:
CML
Conditions: Official terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Tyrosine Kinase Inhibitors
Conditions: Keywords:
DISCONTINUATION
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
multicentre, open-label, uncontrolled trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment
Description:
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment with a scheduled
molecular monitoring until month 24.
Arm group label:
CML patient TKI discontinuation study
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.
Criteria for eligibility:
Criteria:
Inclusion criteria:
1. Signed Informed consent.
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:
1. Patients who previously discontinued TKI and demonstrated recurrence of the disease.
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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
FUNDALEU
Address:
City:
Ciudad Autonoma de Buenos Aire
Zip:
1114
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Carolina Pavlovsky, MD
Phone:
+541148771070
Email:
cpavlovsky@fundaleu.org.ar
Contact backup:
Last name:
Mariana Juni
Phone:
+541148771070
Email:
mjuni@fundaleu.org.ar
Investigator:
Last name:
Carolina Pavlovsky, MD
Email:
Principal Investigator
Investigator:
Last name:
Beatriz Moiraghi, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ana I Varela, MD
Email:
Sub-Investigator
Investigator:
Last name:
Michele Bianchini
Email:
Sub-Investigator
Start date:
February 1, 2019
Completion date:
January 2025
Lead sponsor:
Agency:
Fundaleu
Agency class:
Other
Source:
Fundaleu
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05926128
