New treatment for newly diagnosed Acute Myeloid Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, open-label, dose-finding study evaluating the safety and efficacy of APVO436 in combination with venetoclax and azacitidine in adult patients with newly diagnosed, CD123-positive Acute Myeloid Leukemia (AML). The study consists of 28-day treatment cycles across five sequential cohorts, with a focus on determining the optimal dosing of APVO436 while minimizing the risk of cytokine release syndrome (CRS). Participants will receive a series of priming doses followed by the determined cohort dose level of APVO436 administered via a 4-hour intravenous infusion.

Why it matters

Who can join: the full rules

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.

Where it's running

• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• University of Kansas
  Fairway, Kansas, United States Recruiting
• Gabrail Cancer Center
  Canton, Ohio, United States Recruiting
• Oncology Hematology Care
  Cincinnati, Ohio, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Caroline Taromino
• Email: tarominoC@apvo.com
• Phone: 7735749572

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PBSS1113 with azacitidine for AML and higher-risk MDS

  This study tests PBSS1113 together with azacitidine to see if it is safe and may help people with AML or higher-risk MDS who are newly diagnosed and not fit for intense chemotherapy or who have relapsed/refractory disease.

  Recruiting Phase 1/2 Chaser Therapeutics, Inc. · Hangzhou, Zhejiang · NCT07761533

• Caris Chromoseq data collection for AML, MDS, and MPN

  This study tests how well the Caris Chromoseq assay helps categorize risk in patients with AML, MDS, or MPN compared with standard tests.

  Recruiting Caris Science, Inc. · Phoenix, Arizona · NCT07680868

• Venetoclax TDM in newly diagnosed AML: exposure and prognosis

  This study checks if measuring venetoclax levels and adjusting treatment helps people with newly diagnosed AML who are getting VEN-AZA.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou · NCT07670130

• CAR-T cells targeting CD33 and CLL1 for relapsed or refractory AML

  A one-arm early-stage trial tests whether a patient’s own engineered CAR-T cells (ICG415) can be safely given after conditioning chemotherapy to see if they can help adults with relapsed or refractory AML.

  Recruiting at 2 sites Phase 1 iCell Gene Therapeutics · Nanchang, Jiangxi and 1 other locations · NCT07668557

• Ziftomenib for relapsed/refractory NPM1-mutated AML in Japanese adults

  This study will test whether ziftomenib can help adults with relapsed or refractory NPM1-mutated AML who have few other options.

  Recruiting at 15 sites Phase 2 Kyowa Kirin Co., Ltd. · Chiba and 19 other locations · NCT07623616

• VABu Conditioning for elderly AML patients undergoing stem cell transplant

  This trial tests a VABu conditioning regimen to see if it helps older AML patients before allogeneic stem cell transplantation.

  Recruiting Phase 2/3 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07583888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.