RECRUITING

APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML

Conditions

Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1b/2 Open-Label Study of APVO436 in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Quick Facts

Study Start:2024-10-01

Study Completion:2028-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06634394

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 cytometry (or immunohistochemistry \[IHC\]). Confirmation at diagnosis is acceptable. 4. Patient must be considered ineligible for induction therapy defined by at least one of the following: 1. ≥75 years of age 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3 3. Cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina) 4. Pulmonary disorder (e.g., DLCO ≤65% or FEV1 ≤65%) 5. Creatinine clearance 30-45 mL/min based on Cockcroft-Gault or Modified of Diet in Renal Disease (MDRD) formular 6. Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN 5. Patient must have a projected life expectancy of ≥12 weeks	1. Patient has received treatment with the following: 1. A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myelodysplastic/myeloproliferative neoplasms (MPS/MPN) 2. CAR-T cell therapy or history of allogeneic hematopoietic stem cell transplant (HSCT) 3. Experimental therapies for MDS or AML 2. Patient is currently participating in another interventional research study. 3. 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. 4. Patient has acute promyelocytic leukemia. 5. Patient has a current autoimmune disorder requiring immunosuppressive therapy such as systemic (oral or IV) steroid therapy \>10 mg methylprednisolone daily or its equivalent 6. Patient is receiving concurrent corticosteroid therapy as an anticancer drug (any dose). 7. 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. 8. Creatinine clearance \<30ml/min based on Cockcroft-Gault or MDRD formular. 9. Bilirubin of \>3xULN in the absence of Gilbert's Syndrome. 10. AST and/or ALT \>3 times the ULN.

Inclusion Criteria

Exclusion 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 cytometry (or immunohistochemistry \[IHC\]). Confirmation at diagnosis is acceptable.
4. Patient must be considered ineligible for induction therapy defined by at least one of the following:
1. ≥75 years of age
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3
3. Cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
4. Pulmonary disorder (e.g., DLCO ≤65% or FEV1 ≤65%)
5. Creatinine clearance 30-45 mL/min based on Cockcroft-Gault or Modified of Diet in Renal Disease (MDRD) formular
6. Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN 5. Patient must have a projected life expectancy of ≥12 weeks

1. Patient has received treatment with the following:
1. A hypomethylating agent, venetoclax, and/or chemotherapeutic agent for AML, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myelodysplastic/myeloproliferative neoplasms (MPS/MPN)
2. CAR-T cell therapy or history of allogeneic hematopoietic stem cell transplant (HSCT)
3. Experimental therapies for MDS or AML
2. Patient is currently participating in another interventional research study.
3. 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.
4. Patient has acute promyelocytic leukemia.
5. Patient has a current autoimmune disorder requiring immunosuppressive therapy such as systemic (oral or IV) steroid therapy \>10 mg methylprednisolone daily or its equivalent
6. Patient is receiving concurrent corticosteroid therapy as an anticancer drug (any dose).
7. 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.
8. Creatinine clearance \<30ml/min based on Cockcroft-Gault or MDRD formular.
9. Bilirubin of \>3xULN in the absence of Gilbert's Syndrome.
10. AST and/or ALT \>3 times the ULN.

Contacts and Locations

Study Contact

Caroline Taromino

CONTACT

7735749572

tarominoC@apvo.com

Principal Investigator

Dirk Huebner, MD

STUDY_DIRECTOR

Aptevo Therapeutics

Study Locations (Sites)

Colorado Blood Cancer Institute

Denver, Colorado, 80218

United States

University of Miami

Miami, Florida, 33124

United States

University of Kansas

Fairway, Kansas, 66205

United States

Gabrail Cancer Center

Canton, Ohio, 44718

United States

Oncology Hematology Care

Cincinnati,, Ohio, 45226

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Aptevo Therapeutics

Dirk Huebner, MD, STUDY_DIRECTOR, Aptevo Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01

Study Completion Date2028-03

Study Record Updates

Study Start Date2024-10-01

Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

Acute Myeloid Leukemia

Additional Relevant MeSH Terms

Acute Myeloid Leukemia (AML)