Safety And Efficacy Of Tyrosine Kinase Inhibitor Cessation For Chronic Myeloid Leukemia Patients With Stable Molecular Response In A Real World Population

Who is this study for? Patients with Chronic Myeloid Leukemia
What treatments are being studied? Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Withdrawal+Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Re-initiation
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Baylor College of Medicine- McNair Campus
RECRUITING
Houston
Ben Taub General Hospital
RECRUITING
Houston
CHI St. Luke's Health Baylor College of Medicine Medical Center
RECRUITING
Houston
Harris Health System- Smith Clinic
RECRUITING
Houston
Contact Information
Primary
Martha Mims, MD, PhD
mmims@bcm.edu
713-798-7535
Time Frame
Start Date: 2020-12-22
Estimated Completion Date: 2025-11-15
Participants
Target number of participants: 100
Treatments
Experimental: All Subjects Enrolled (stop taking TKI)
Patients with 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, and whom have been taking TKI for \> 36 months with a current status of complete molecular remission (CMR). TKI cessation begins within 7 days of study registration. Patients undergo BCR-ABL1 test every month in 24 months.
Sponsors
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov