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

NCT05926128 | Unknown

• 2 other identifiers: Argentina Stop TrialAST2018
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

CML

Keywords

DISCONTINUATION

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treatment-free survival during 24 months

  24 months

Other Outcomes (2)

• Overall survival during 24 months

  24 months

• Pharmacoeconomic analysis during 24 months

  24 months

Study Arms (1)

CML patient TKI discontinuation study

OTHER

Treatment free remission in patients with chronic myeloid leukemia in chronic phase who achieved deep molecular response with tyrosine kinase inhibitors

Drug: Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment

Interventions

Discontinuing treatment with Tyrosine Kinase Inhibitor after enrolment DRUG

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

CML patient TKI discontinuation study

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundaleu: lead

Study Sites (1)

FUNDALEU

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1114, Argentina

RECRUITING

Central Study Contacts

Carolina Pavlovsky, MD

CONTACT

+541148771070; cpavlovsky@fundaleu.org.ar

Mariana Juni

CONTACT

+541148771070; mjuni@fundaleu.org.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Clinical Research Area

Model Details: multicentre, open-label, uncontrolled trial

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: July 3, 2023
• Study Start: February 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2025
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)