NCT06390306 The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP
| NCT ID | NCT06390306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Chronic Myeloid Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-07-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective multi-center study to investigate efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) combined with azacitidine and B-cell lymphoma-2 (Bcl-2) inhibitor in patients with myeloid blast phase chronic myeloid leukemia (CML-MBP).
Eligibility Criteria
Inclusion Criteria: 1. age ≥ 18 years old; 2. philadelphia chromosome (Ph)-positive or BCR::ABL-positive; 3. serum creatinine ≤ 1.5 × upper limit of normal (ULN) or 24h creatinine clearance ≥ 50 mL/min when serum creatinine was \> 1.5 × ULN; 4. serum total bilirubin ≤ 1.5 × ULN; 5. aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN; 6. amylase ≤ 1.5 × ULN; (7) lipase ≤ 1.5 × ULN; 7. ejection fraction \> 50%; corrected QT interval on electrocardiographic evaluation was ≤ 450 ms in men or ≤ 470 ms in women. Exclusion Criteria: 1. concurrent diseases requiring treatment(s) with potential to interact with 3G-TKI; 2. diagnosis of other primary malignancies; 3. history of allogeneic HSCT; 4. extramedullary disease only.
Contact & Investigator
Qian Jiang, MD
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06390306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06390306 currently recruiting?
Yes, NCT06390306 is actively recruiting participants. Contact the research team at jiangqian@medmail.com.cn for enrollment information.
Where is the NCT06390306 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Chengdu, China and 11 additional locations.
Who is sponsoring the NCT06390306 clinical trial?
NCT06390306 is sponsored by Peking University People's Hospital. The principal investigator is Qian Jiang, MD at Peking University People's Hospital. The trial plans to enroll 30 participants.
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