Multicenter, Open-label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients Who Are Not Candidates for Intensive Therapy

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Men and women ≥18 years old

• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study

• Diagnosis of AML according to ICC 2022 (with the exclusion of MDS/AML with 10-19% blasts)

• Previously untreated AML except may have received emergency leukapheresis, hydroxyurea before study entry to control hyperleukocytosis

• Deemed unfit for intensive chemotherapy by meeting at least 1 of the following criteria:

‣ Participant is ≥75 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 OR

⁃ Participant is ≥18 to 74 years of age and has any of the following comorbidities:

• ECOG performance status of 2 or 3

∙ Cardiac status including any one of the following: congestive heart failure requiring treatment or ejection fraction ≤50% or chronic stable angina

∙ Known history of diffusion capacity of lung for carbon monoxide (DLCO) ≤65% of forced expiratory volume in the first second (FEV1) ≤65%

∙ Creatinine clearance (CrCl) ≥15 mL/min to \<45 mL/min

∙ Hepatic disorder with total bilirubin \>1.5 to 3x the upper limit of normal (ULN)

∙ Any other comorbidity that the investigators determine to be incompatible with conventional intensive chemotherapy

• Adequate liver and renal function defined as:

‣ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3xULN; for participants with leukemic infiltration of the liver (documented by biopsy or imaging), AST and ALT \<5xULN is permitted

⁃ Total bilirubin ≤1.5xULN, unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin. Participants who are \<75 years of age may have a bilirubin up to 3xULN.

⁃ Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease \[MDRD\] formula). Participants who are \<75 years of age may have an eGFR ≥15 mL/min/1.73 m2.

• Women of childbearing potential (WOCBP), defined as fertile women between menarche and post menopause unless permanently sterile, must have a negative highly sensitive serum β-human chorionic gonadotropin (β-hCG) or urine pregnancy test at screening

• Must be willing to use contraception as consistent with institutional guidelines regarding the use of contraceptive methods for participants participating in clinical studies

‣ WOCBP must agree to adhere to the following birth control measures while receiving study treatment continuing to 3 months after the last dose of study drug:

• Must be practicing a highly effective method of birth control (failure rate of \<1% per year when used consistently and correctly) as determined by institutional standards

∙ Must agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction

∙ Must not be breastfeeding and not planning to become pregnant

⁃ Male participants who are sexually active with WOCBP, and male partners of study participants who are WOCBP, and who are not surgically or otherwise sterile must agree to adhere to the following birth control measures while receiving study treatment and for 3 months after the last dose of study drug:

• Must agree to use a barrier method of birth control (e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap \[diaphragm or cervical/vault caps\] with spermicidal foam, gel, film, cream, or suppository)

∙ Must not donate sperm

∙ Must no plan to father a child

• Participants with HIV infection are eligible for the trial if the following criteria are met:

‣ CD4+ T-cell count ≥200 cells/μL

⁃ No prior history of AIDS-defining opportunistic infection within the past 12 months

⁃ Receiving treatment with antiretroviral therapy

⁃ Undetectable viral load within 6 months of screening

Locations
United States
Arizona
Banner MD Anderson
RECRUITING
Gilbert
California
City of Hope
RECRUITING
Duarte
University of California Los Angeles
RECRUITING
Los Angeles
Colorado
University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus
RECRUITING
Aurora
Connecticut
Yale School of Medicine
RECRUITING
New Haven
Florida
AdventHealth Medical Group Blood &amp; Marrow Transplant at Orlando
RECRUITING
Orlando
Iowa
The University of Iowa Hospitals & Clinics
RECRUITING
Iowa City
Kentucky
University of Kentucky Chandler Medical Center
RECRUITING
Lexington
Norton Healthcare, Inc.
RECRUITING
Louisville
North Carolina
Wake Forest North Carolina
NOT_YET_RECRUITING
Winston-salem
New Jersey
Hackensack University Medical Center
NOT_YET_RECRUITING
Hackensack
New York
Hofstra/Northwell Health
RECRUITING
Lake Success
Cornell University
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Washington
Fred Hutch Seattle Cancer Care Alliance
RECRUITING
Seattle
Wisconsin
Medical College of Wisonsin
NOT_YET_RECRUITING
Milwaukee
Other Locations
Canada
Tom Baker Cancer Center-Alberta Health Services - University of Calgary
RECRUITING
Calgary
Stollery Children's Hospital-Walter C Mackenzie Health Sciences Centre - University of Alberta
RECRUITING
Edmonton
University of Western Ontario
RECRUITING
London
The Ottawa Hospital - General Campus
RECRUITING
Ottawa
Saskatchewan Cancer Agency - Saskatoon Cancer Centre
RECRUITING
Saskatoon
Princess Margaret Cancer Centre
RECRUITING
Toronto
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
RECRUITING
Vancouver
Germany
Marien Hospital Duesseldorf
RECRUITING
Düsseldorf
Universitaetsklinik Frankfurt
RECRUITING
Frankfurt
Medizinische Hochschule Hanover, Hannover Medical School
RECRUITING
Hanover
Universitaetsklinik um Schleswig-Holstein, UKSH-Campus Kiel
RECRUITING
Kiel
Switzerland
Inselspital Bern
RECRUITING
Bern
HFR Fribourg - Hopital Cantonal
RECRUITING
Fribourg
Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Contact Information
Primary
OncoVerity OncoVerity
helpdesk@oncoverity.com
8002201674
Time Frame
Start Date: 2024-07-22
Estimated Completion Date: 2027-06
Participants
Target number of participants: 120
Treatments
Experimental: Cusatuzumab in combination with venetoclax and azacitidine
Cusatuzumab 20 mg/kg administered intravenously on days 3 and 17 in combination with venetoclax administered orally up to 400 mg once daily and azacitidine 75 mg/m\^2 administered subcutaneously or intravenously once daily for 7 days of a 28 day cycle
Active_comparator: Venetoclax in combination with azacitidine
Venetoclax administered orally up to 400 mg once daily and azacitidine 75 mg/m\^2 administered subcutaneously or intravenously once daily for 7 days of a 28 day cycle
Related Therapeutic Areas
Sponsors
Leads: OncoVerity, Inc.

This content was sourced from clinicaltrials.gov