OncoMatch/Clinical Trials/NCT04626024
Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real World Population
Is NCT04626024 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Re-initiation for chronic myeloid leukemia.
Treatment: Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Re-initiation — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: BCR BCR-ABL1 fusion (quantifiable transcript by RT-PCR)
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
Required: BCR BCR-ABL1 fusion (MR4.5 for ≥24 months, as documented by ≥3 separate tests performed at least three months apart)
history of stable molecular response, defined as MR4.5 for ≥24 months, as documented by ≥3 separate tests performed at least three months apart
Required: BCR BCR-ABL1 fusion (MR4.5 (CMR) within 30 days of signing consent)
current status of complete molecular remission (CMR), defined as MR4.5 (per section 5.1), within 30 days of signing consent
Disease stage
Required: Stage REMISSION
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: tyrosine kinase inhibitor
Patients who have been taking TKI for > 36 months
Cannot have received: allogeneic stem cell transplantation
Previous or planned allogeneic stem cell transplantation
Cannot have received: investigational agent
Patient has received an investigational agent within last 2 years
Lab requirements
Blood counts
ANC ≥ 1.5 x 10E9/L; Hemoglobin ≥ 9.0 g/dL; Platelets ≥ 100 x 10E9/L
Patients must have normal marrow function within 30 days of registration, as defined: ANC ≥ 1.5 x 10E9/L; Hemoglobin ≥ 9.0 g/dL; Platelets ≥ 100 x 10E9/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baylor College of Medicine- McNair Campus · Houston, Texas
- Ben Taub General Hospital · Houston, Texas
- CHI St. Luke's Health Baylor College of Medicine Medical Center · Houston, Texas
- Harris Health System- Smith Clinic · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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