Evaluating treatment-free remission in chronic myeloid leukemia patients

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)

This study is testing if people with chronic myeloid leukemia can stay in remission after stopping their medication and looking at their immune system during that time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Fundaleu (other)
• Drugs / interventions: Imatinib, Nilotinib, Dasatinib
• Locations: 1 site (Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires)
• Trial ID: NCT05926128 on ClinicalTrials.gov

What this trial studies

This study aims to assess the persistence of complete molecular remission in patients with chronic myeloid leukemia (CML) who have achieved deep molecular response after discontinuing tyrosine kinase inhibitor (TKI) treatment. It is a multicenter, open-label trial that will also characterize the immunological status of these patients at the time of TKI interruption and at 3 months post-interruption. The study will evaluate the proportion of patients maintaining major molecular response after stopping TKI therapy and will explore the pharmacoeconomic implications of treatment interruption.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic phase CML who have maintained a deep molecular response for at least two years while on TKI therapy.

Not a fit: Patients who have previously discontinued TKI treatment and experienced disease recurrence or those with accelerated phase or blast crisis CML will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the possibility of safely discontinuing TKI treatment for CML patients without disease recurrence.

How similar studies have performed: Other studies have shown promising results in treatment-free remission for CML patients, suggesting that this approach may be viable.

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

Where this trial is running

Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires

• FUNDALEU — Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina (RECRUITING)

Study contacts

• Study coordinator: Carolina Pavlovsky, MD

Conditions: CML, DISCONTINUATION