APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
About this study
A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.
- Condition
- Acute Myeloid Leukemia (AML)
- Tested
- APVO436, Venetoclax, Azacitidine
- Sponsor
- Aptevo Therapeutics
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 11
- Minimum age: 18 years
- Study condition: Acute Myeloid Leukemia (AML)
- 1\. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World Health Organization (WHO) criteria and not been previously treated.
- \. Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry \[IHC\]). Confirmation at diagnosis is acceptable.
- \. Patient must be considered ineligible for induction therapy defined by at least one of the following:
- ≥75 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3
- Cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
- Pulmonary disorder (e.g., DLCO ≤65% or FEV1 ≤65%)
- Creatinine clearance 30-45 mL/min based on Cockcroft-Gault or Modified of Diet in Renal Disease (MDRD) formular
- Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN 5. Patient must have a projected life expectancy of ≥12 weeks
Exclusion 13
- Patient has received treatment with the following:
- A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myelodysplastic/myeloproliferative neoplasms (MPS/MPN)
- CAR-T cell therapy or history of allogeneic hematopoietic stem cell transplant (HSCT)
- Experimental therapies for MDS or AML
- Patient is currently participating in another interventional research study.
- Patient has history of MPN including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation.
- Patient has acute promyelocytic leukemia.
- Patient has a current autoimmune disorder requiring immunosuppressive therapy such as systemic (oral or IV) steroid therapy \>10 mg methylprednisolone daily or its equivalent
- Patient is receiving concurrent corticosteroid therapy as an anticancer drug (any dose).
- Patient has known active CNS involvement with AML. Patients who received intrathecal chemotherapy for prophylaxis of AML in the CNS prior to enrollment may enroll in this study.
- Creatinine clearance \<30ml/min based on Cockcroft-Gault or MDRD formular.
- Bilirubin of \>3xULN in the absence of Gilbert's Syndrome.
- AST and/or ALT \>3 times the ULN.
Where
7 sites, 7 recruiting
Gabrail Cancer Center
Canton, Ohio, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Kansas
Fairway, Kansas, United States
MD Anderson Cancer Center
Houston, Texas, United States
and 1 more site on ClinicalTrials.gov
Contact
-
Caroline Taromino
7735749572 tarominoC@apvo.com
Potential match only. Final eligibility is determined by the study team.