Pivekimab Sunirine with Venetoclax and Azacitidine in AML for patients who can’t have intensive chemo

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 Phase 2/Phase 3 interventional trial evaluating a combination therapy for newly diagnosed AML patients who are unsuitable for intensive induction therapy. Patients receive Pivekimab Sunirine with venetoclax and azacitidine, along with a matching placebo for PVEK. Phase 2 is open-label and randomized; Phase 3 is double-blind and randomized to compare the active regimen against control. The study monitors adverse events and changes in disease activity to determine safety and potential efficacy. Eligible participants are CD123-positive, untreated AML patients with limited fitness for intensive chemotherapy and a projected life expectancy of at least 12 weeks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must have newly diagnosed, untreated confirmed acute myeloid leukemia (AML) diagnosis as per the 5th edition of World Health Organization (WHO) criteria with a projected life expectancy of at least 12 weeks.
2. CD123-positive
3. Ineligible for intensive induction therapy (chemotherapy) defined by:

   * ≥ 75 years of age OR
   * ≥ 18 to 74 years of age with at least one of the following co-morbidities:

     * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3
     * Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina
     * Diffusion capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%
     * Creatinine clearance ≥ 30 mL/min to \< 45 mL/min
     * Moderate hepatic impairment with total bilirubin \> 1.5 to ≤ 3.0 × upper limit of normal (ULN)
     * Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the medical monitor before study enrollment.
4. ECOG performance status 0 to 2 for subjects ≥ 75 years of age or 0 to 3 for subjects ≥ 18 to 74 years of age.
5. White blood cell (WBC) count \< 25 × 10\^9/L (hydroxyurea is permitted prior to beginning study treatment to reduce the WBC count to \< 25 × 10\^9/L).
6. Subjects must have adequate organ function:

   * Adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.
   * Adequate liver function as demonstrated by:

     * Aspartate aminotransferase (AST) ≤ 3.0 × ULN\*,
     * Alanine aminotransferase (ALT) ≤ 3.0 × ULN\*,

       ---\*Unless considered due to leukemic organ involvement
     * Subjects \< 75 years of age may have total bilirubin ≤ 3 x ULN
     * Subjects ≥ 75 years of age total bilirubin ≤ 1.5 × ULN unless elevated level is considered to be due to Gilbert's syndrome or hemolysis, total bilirubin must be \< 3 x ULN and direct bilirubin \< 1 x ULN
     * Activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 × ULN International Normalized Ratio (INR) \<1.5

Exclusion Criteria:

* Acute promyelocytic leukemia (APL), blast phase of CML or AML with t(9;22) or BCR:ABL1 fusion, transformation from myeloproliferative neoplasm (MPN), Chronic Myelomonocytic Leukemia (CMML), myelodysplastic/myeloproliferative neoplasm unspecified, or myeloid sarcoma.
* Known active central nervous system (CNS) involvement with AML. Participants may have non-CNS extramedullary disease (excludes participants with myeloid sarcoma as the only disease manifestation at screening).
* Participants with history of any malignancies within 2 years prior to screening with exception of: adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of the breast, in situ - carcinomas of bladder and esophagus; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, and previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and have no evidence of relapse within 2 years.
* Participants must not have received a hypomethylating agent, any BCL-2 inhibitors including venetoclax, and/or chemotherapeutic agent for Myelodysplastic syndromes (MDS) or AML, CAR-T cell therapy, be currently participating in another clinical study, received any investigational treatment within 30 days prior to the first use of study combination product.
* Female participant must not be pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study and for approximately 7 months after the last dose of any study drug. Female participant of childbearing potential must agree to use at least 1 protocol specified method of birth control and male participant, if sexually active with female partner(s) of childbearing potential, must agree to practice the protocol-specified contraception.

Where it's running

• City of Hope National Medical Center /ID# 279568
  Duarte, California, United States Recruiting
• Moffitt Cancer Center /ID# 279192
  Tampa, Florida, United States Recruiting
• Winship Cancer Institute of Emory University /ID# 279006
  Atlanta, Georgia, United States Recruiting
• Washington University /ID# 280295
  St Louis, Missouri, United States Recruiting
• Montefiore Medical Center - Moses Campus /ID# 279399
  The Bronx, New York, United States Recruiting
• The University of Texas MD Anderson Cancer Center /ID# 279402
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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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.