Status:
UNKNOWN
Combination of Venetoclax, Hypomethylation Agent and Low-dose Cytarabine as a Salvage Therapy for Acute Myeloid Leukemia
Lead Sponsor:
Beijing 302 Hospital
Conditions:
Relapsed Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Although studies are ongoing to evaluate the efficiency and safety of venetoclax-based therapy, alone or in combination with hypomethylation agent or low-dose cytarabine, in relapsed/refractory acute ...
Detailed Description
Although the promising activity of venetoclax-based therapy is well demonstrated in the treatment of previously untreated elderly or unfit patients with acute myeloid leukemia, there are few data on t...
Eligibility Criteria
Inclusion
- Aged ≥18 years old, voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
- The toxic and side effects caused by the last treatment should be recovered.
- Eastern Cooperative Oncology Group score of 0 to 3 points.
- The organ function is intact.
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (Upper Limit of Normal).
- Creatinine≤1.5×ULN.
- Bilirubin≤1.5×ULN.
- Karnofsky≥70.
- The expected survival period is at least 12 weeks.
- Non-pregnant, non-breastfeeding women.
Exclusion
- Suffering from other untreated or unrelieved malignant tumors within 2 years.
- Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.
- Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association \[NYHA\] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.
- Patients who are unwilling or unable to comply with the protocol.
- Currently being treated with other systemic anti-tumor or anti-tumor research drugs.
- Women who are pregnant or breastfeeding.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05362942
Start Date
May 1 2022
End Date
April 30 2024
Last Update
May 5 2022
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