Treatment for chronic myeloid leukemia patients who didn't respond to previous therapies
Treatment With Olverembatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Failed to at Least Two Previously Administered Second-generation Tyrosine Kinase Inhibitors: a Prospective, Single-arm Clinical Trial.
This study is testing a new medication called olverembatinib to see if it can help people with chronic myeloid leukemia who haven't improved with other treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shenzhen Second People's Hospital Academic / other |
| Drugs / interventions | olverembatinib |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT05311943 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the efficacy and safety of olverembatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have failed to respond to at least two second-generation tyrosine kinase inhibitors. The study aims to determine the major molecular responses (MMR) to olverembatinib after 12 months of treatment. Participants will be monitored for their response to the medication and any potential side effects throughout the trial period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of CML-CP who have shown resistance or intolerance to at least two second-generation TKIs.
Not a fit: Patients with known allergies to the study drug or its components, or those with other malignant tumors, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with CML-CP who have limited alternatives.
How similar studies have performed: Other studies have shown promising results with similar approaches, but the specific use of olverembatinib in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years and ≤75 years. * Diagnosis of CML-CP. * ECOG performance of 0-2. * Adequate end organ function defined as the following: total bilirubin \<1.5xULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN. * Resistance and/or intolerance of at least two second-generation TKIs. * Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital. Exclusion Criteria: * Known to be allergic to study drug ingredients or their analogues. * History of undergone major surgery within 4 weeks. * Patients unwilling or unable to comply with the protocol. * Pregnant or breast-feeding patients. * patients with other malignant tumor.
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xin Du, Phd
- Email: duxingz@medmail.com.cn
- Phone: 075583366388
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.