Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05926128
Other study ID # Argentina Stop Trial
Secondary ID AST2018
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT00333190 - CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation N/A
Terminated NCT01131325 - Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations Phase 4
Active, not recruiting NCT03578367 - Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Phase 2
Completed NCT03747679 - Palatability (Taste) of Oral Formulations of Bosutinib Phase 1
Completed NCT01019317 - Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS) Phase 2
Recruiting NCT06131801 - Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Not yet recruiting NCT06423911 - A Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With CML Phase 3
Completed NCT03880617 - Distress, Medication Adherence and Care Needs in Patients With CML and GIST Receiving Oral Targeted Therapy
Completed NCT00858572 - STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders Phase 1
Completed NCT00684008 - Safety Study of IL-7 in Recipients of a Hemopoietic Stem Cell Transplant Peripheral Blood Stem Cell Transplant Phase 1
Completed NCT00013533 - Pilot Study of Non-Myeloablative, HLA-Matched Allogeneic Stem Cell Transplantation for Pediatric Hematopoietic Malignancies Early Phase 1
Not yet recruiting NCT06047886 - CD34 Selection Using the Automated CliniMACS Prodigy Phase 1
Recruiting NCT05823571 - Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients Phase 1
Completed NCT00780104 - Sirolimus in Combination With MEC in High Risk Myeloid Leukemias Phase 1
Recruiting NCT06211166 - Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction
Recruiting NCT01762969 - Treatment Modification Based on Early Assessment of CML Patients Phase 2
Completed NCT00891592 - Umbilical Cord Blood Transplant for Hematological Malignancies Phase 1
Terminated NCT00776373 - Rapamycin in With High-Dose Etoposide and Cytarabine in Relapsed/Refractory Aggressive Lymphoid Malignancies Phase 1/Phase 2
Completed NCT00511537 - Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders N/A
Recruiting NCT05152537 - FLOR3 Gene Polymorphism in Predicting Outcomes of Tyrosine Kinase Inhibitor(TKI)Stopping in Chronic Myeloid Leukemia