Reducing and stopping second-generation cancer drugs in CML patients
This Study is a Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Drug Discontinuation After Dose Reduction in Ph+CML-CP Patients Threated With 2G-TKI.
This study is testing whether cutting the dose of cancer drugs in half and then stopping them altogether can be safe for people with chronic myeloid leukemia who have been doing well on their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | nilotinib, dasatinib |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT05341050 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP) who have been on second-generation tyrosine kinase inhibitors (TKIs) like nilotinib or dasatinib for at least three years and have maintained a major molecular response (MMR) for two years. Participants will have their TKI dosage halved for 12 months, followed by a complete withdrawal of the medication for another 12 months, while their molecular response will be closely monitored through blood tests. If any signs of molecular recurrence are detected, the original TKI dosage will be reinstated.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with Ph+ CML-CP who have been on second-generation TKIs for at least three years and have maintained MMR for at least two years.
Not a fit: Patients with a history of T315I mutation, severe cardiovascular disease, or those who have undergone allogeneic stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could allow patients to maintain their remission while reducing medication side effects and costs.
How similar studies have performed: While this specific approach is novel, similar studies have shown promise in managing CML with reduced TKI dosages.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female over 18 years 2. Patients diagnosed as Ph+ (or Ph- but PCR-positive for BCR-ABL) CML-CP 3. Patients have received one of the second-generation TKIs (nilotinib, dasatinib) for at least 3 years 4. Patients have maintained MMR (BCR/ABL IS\<0.1% or more) at least 2 years 5. in the past 24 months, at least three times recent molecular reactions have confirmed MMR 6. Patients have signed the informed consent Exclusion Criteria: 1. patients with the presence or history of T315I mutation 2. patients with the presence of rare unquantifiable atypical transcripts 3. Patients with comorbid cardiovascular disease or a history of severe cardiovascular disease 4. patients have history of accelerated or blast phase, or suspected blast disease 5. patients have received allogeneic hematopoietic stem cell transplantation 6. patients have severe abnormal liver and kidney function (ALT \> upper limit of normal, AST \> 3 times normal upper line, glomerular filtration rate \< 50%) 7. patients combined with other tumors or a history of other malignancies ECOG score\>3 8. Two-line abnormality in the patient's blood routine examination 9. women is pregnant or nursing
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- NanfangH — Guangzhou, Guangdong, China (Not_yet_recruiting)
- NanfangH — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: xu na
- Email: sprenaa@163.com
- Phone: 18620698390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.