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New treatment option for Acute Myeloid Leukemia (AML)
Official title APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
ClinicalTrials.gov ID: NCT06634394
What this study is testing
What is APVO436?
APVO436 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia (aml).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World Health Organization (WHO) criteria and not been previously treated...
- ≥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%)
You likely can't join if
- Patient has received treatment with the following:
- A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML)...
- 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 treatment research study.
- Patient has history of MPN including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without...
See the full eligibility criteria
- 1\. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World Health Organization (WHO) criteria and not been previously treated. 3\. Patients must have CD123-positive AML as confirmed by local flow...
- ≥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
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Miami, Florida, United States
- Fairway, Kansas, United States
- Canton, Ohio, United States
- Cincinnati, Ohio, United States
- Dallas, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Miami, Florida, United States; Fairway, Kansas, United States; Canton, Ohio, United States; Cincinnati, Ohio, United States; Dallas, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.