Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real World Population

Running, not enrolling · Phase 2

Conditions studied: Chronic Myeloid Leukemia, Chronic Myeloid Leukemia, BCR/ABL-Positive, in Remission, Chronic Myeloid Leukemia in Remission

In brief

This is a single-arm, phase II study to evaluate safety and efficacy of tyrosine kinase inhibitor (TKI) cessation for chronic myeloid leukemia (CML) patients with stable molecular response in a real world population.

Key facts

Study ID

NCT04626024

Run by

Baylor College of Medicine

People needed

17

Starts

2020-12-22

Expected to finish

2028-11-15

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are 18 years or older
• Patients have a diagnosis of Philadelphia chromosome- or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR).
• Prior evidence of a quantifiable BCR-ABL1 transcript by RT-PCR
• Patients who have been taking TKI for > 36 months.
• Patients must have a history of stable molecular response, defined as MR4.5 for ≥24 months, as documented by ≥3 separate tests performed at least three months apart.
• Patient must have a current status of complete molecular remission (CMR), defined as MR4.5 (per section 5.1), within 30 days of signing consent.
• ECOG performance status < 2
• Patients must have normal marrow function within 30 days of registration, as defined:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 10E9/L
• Hemoglobin ≥ 9.0 g/dL
• Platelets ≥ 100 x 10E9/L
• Patients must not have any signs of extramedullary leukemia
• Patients must have a life expectancy of more than 12 months in the absence of any intervention
• All participants must be informed of the investigational nature of this study and must sign and give written informed consent
• Contraception requirements will be as per routine clinical practice.

You may not qualify if…

• Patients who are unable or unwilling to give their consent to participate to the study.
• Previous or planned allogeneic stem cell transplantation
• Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping Imatinib.
• Patient has received an investigational agent within last 2 years
• Atypical BCR-ABL transcript not quantifiable by standard RQ-PCR.
• Patient cannot have had a known interruption of TKI therapy of greater than 14 consecutive days or for a total of 6 weeks in the six months prior to registration.
• Another primary malignant disease, except those that do not currently require treatment (adequately treated conditions, such as excised skin cancer or cervical intra-epithelial neoplasia would not be considered exclusion criteria. If in doubt, please refer to the Principal Investigator).
• Any medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study.
• Active liver disease (e.g., chronic active hepatitis, cirrhosis).
• Known diagnosis of human immunodeficiency virus (HIV) infection.

Where it is running

• Baylor College of Medicine- McNair Campus — Houston, Texas, United States
• Ben Taub General Hospital — Houston, Texas, United States
• CHI St. Luke's Health Baylor College of Medicine Medical Center — Houston, Texas, United States
• Harris Health System- Smith Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.