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NCT06634394 | RECRUITING | Acute Myeloid Leukemia (AML)

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

Aptevo Therapeutics

Brief Summary:

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 or disease

Acute Myeloid Leukemia (AML)

Intervention/treatment

APVO436

Venetoclax

Azacitidine

Phase

PHASE1

Detailed Description:

Phase 1b consists of 28-day cycles of treatment in five sequential cohorts. In Cycle 1 (C1) only, to reduce the risk of CRS, each cohort will receive 4 priming doses of APVO436 respectively. APVO436 will be given in combination with venetoclax and azacitidine. For C1D15 and all doses in each subsequent cycle, cohorts will receive APVO436 at the determined cohort dose level. APVO436 dosing will be administered by a 4-hour intravenous (IV) infusion.

Study Type : INTERVENTIONAL
Estimated Enrollment : 39 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-10-01
Estimated Primary Completion Date : 2027-10
Estimated Study Completion Date : 2028-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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
Exclusion Criteria
  • 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.
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML

Location Details

NCT06634394

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33124

RECRUITING

United States, Kansas

University of Kansas

Fairway, Kansas, United States, 66205

RECRUITING

United States, Ohio

Gabrail Cancer Center

Canton, Ohio, United States, 44718

RECRUITING

United States, Ohio

Oncology Hematology Care

Cincinnati,, Ohio, United States, 45226

RECRUITING

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030