Status:
UNKNOWN
A Phase 2 Study of Venetoclax in Combination With Low-dose HHT, G-CSF, and AZA as First-line Treatment for Newly Diagnosed Elderly AML Patients Unfit for Intensive Chemotherapy
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
Acute myeloid leukemia (AML) is a group of heterogeneous malignancies derived from hematopoietic precursors. Patients older than 65 years can hardly benefit from standard intensive chemotherapy while ...
Eligibility Criteria
Inclusion
- Participant must have confirmation of Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria, previously untreated and unfit for intensive chemotherapy
- Participant must be \>= 60 years of age.
- Participant must have a projected life expectancy of at least 12 weeks.
- Participant must have adequate renal function as demonstrated by a creatinine \>= 30 mL/min;determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula
- Participant must have adequate liver function as demonstrated by:
- aspartate aminotransferase (AST) \<= 3.0 x ULN\*
- alanine aminotransferase (ALT) \<= 3.0 x ULN\*
- bilirubin \<= 1.5 x ULN\* \* Unless considered to be due to leukemic organ involvement i. Subjects who are \< 75 years of age may have a bilirubin of \<= 3.0 x ULN
Exclusion
- Participant has history of myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation
- Participant has acute promyelocytic leukemia
- Participant has known active central nervous system (CNS) involvement with AML
- Participant is known to be positive for hepatitis B or C infection
- Participant has received anticancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents within 5 half-lives prior to first dose of study drug
- Participant has received biologic agents (e.g. monoclonal antibodies) for anti-neoplastic intent within 30 days prior to first dose of study drug
- Participant has received the following within 7 days prior to the first dose of the study drug:
- Steroid therapy for anti-neoplastic intent;
- Strong and Moderate CYP3A inhibitors (see Appendix A for examples)
- Strong and Moderate CYP3A inducers (see Appendix A for examples)
- Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy
- Participant has a serious cardiovascular, pulmonary or renal disability
- Participant has a history of other malignancies within 2 years prior to study entry, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; requires discussion with TA MD.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04824924
Start Date
March 1 2021
End Date
March 1 2024
Last Update
April 1 2021
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