Study of Treatment Free Remission in Patients With Chronic Myeloid Leukemia in Chronic Phase

CML Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926128
• Other study ID #: Argentina Stop Trial
• Secondary ID: AST2018
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 2025

Study information

• Verified date: June 2023
• Source: Fundaleu
• Contact: Carolina Pavlovsky, MD
• Phone: +541148771070
• Email: cpavlovsky[@]fundaleu.org.ar
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 2025
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• CML
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention

Drug:
• Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment
Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment with a scheduled molecular monitoring until month 24.

Locations

Country	Name	City	State
Argentina	FUNDALEU	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Fundaleu

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival during 24 months	Overall survival, defined from the day of TKI interruption until date of death, date of last contact or loss of follow-up.	24 months
Other	Pharmacoeconomic analysis during 24 months	Calculate the total saving of the included patients un US dollars, considering the costs of TKIs, PCRs performing and medical visits,	24 months
Primary	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	24 months
Secondary	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.	24 months