Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Registration Number
- NCT02785900
- Lead Sponsor
- Seagen Inc.
- Brief Summary
The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.
- Detailed Description
Hypomethylating agents (HMAs), such as decitabine or azacitidine, are considered a standard treatment for older patients with AML. The primary goals of this study are to test whether patients treated with an HMA (either decitabine or azacitidine) in combination with 33A will have better anti-tumor activity and/or survive longer than patients treated with an HMA in combination with placebo.
Patients who meet eligibility criteria will be randomly assigned to one of two treatment groups: 1) 33A plus HMA (Experimental Arm); or 2) placebo plus HMA (Comparator Arm). In addition to evaluating survival and remission rates, the minimal residual disease (MRD)-negative remission rate, duration of remission, event free- and leukemia-free survival, and safety and tolerability will be compared between arms.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 240
- Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo or secondary AML according to World Health Organization (WHO) classification (except for acute promyelocytic leukemia (APL))
- Intermediate or adverse cytogenetic risk
- Eligible for therapy with either decitabine or azacitidine
- Acceptable hematologic and organ function
- AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or t(15;17)
- Patients who are candidates for allogeneic stem cell transplant at the time of enrollment
- Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis
- Received prior treatment with HMA or chemotherapy for antecedent myelodysplastic syndrome (MDS)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 33A + HMA 33A 33A plus azacitidine or decitabine 33A + HMA decitabine 33A plus azacitidine or decitabine placebo + HMA placebo placebo plus azacitidine or decitabine 33A + HMA azacitidine 33A plus azacitidine or decitabine placebo + HMA azacitidine placebo plus azacitidine or decitabine placebo + HMA decitabine placebo plus azacitidine or decitabine
- Primary Outcome Measures
Name Time Method Overall Survival Up to 1.5 years Time from randomization to death due to any cause
Composite Complete Remission (CRc) Rate Up to 1.5 years Number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) according to the modified response criteria for acute myeloid leukemia (AML) per Cheson 2003.
- Secondary Outcome Measures
Name Time Method Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate Up to 1.5 years Number of patients who achieve both remission (CR or CRi) and MRD-negative status
Event-free Survival Up to approximately 11.24 months Event-free survival is calculated from the time of randomization to the first documentation of progression, relapse, or death, whichever comes first. Patients who do not have event (progression, relapse, or death) prior to analysis cutoff date are censored at the date of last response assessment. Patients who started another anticancer therapy before progression, relapse, or death are censored at the date of last response assessment prior to the start of new therapy. Patients who do not have response assessment post-baseline are censored at the date of randomization.
Duration of Remission Up to approximately 9.5 months Duration of remission is calculated from the first documentation of CR or CRi to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.
Leukemia-free Survival Up to approximately 9.49 months Leukemia-free survival is calculated from the first documentation of blast clearance (CR, CRi, mLFS) to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.
Incidence of Grade 3 or Higher Laboratory Abnormalities Up to 1.5 years Participants who experienced a laboratory grade increase to Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\], v4.03)
Time to Complete Remission Up to 1.5 years Time to CR or CRi is the time from randomization to the first documentation of CR/CRi
Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events Up to 1.5 years Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. SAE = serious adverse event. "Study treatment" in this data set refers to blinded study treatment.
Mortality Rates at Day 30 and Day 60 Up to 60 days 30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method.
Trial Locations
- Locations (128)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Pacific Hematology Oncology Associates
🇺🇸San Francisco, California, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Florida Cancer Specialists - South Region
🇺🇸Fort Myers, Florida, United States
Shands Cancer Center / University of Florida
🇺🇸Gainesville, Florida, United States
Memorial Cancer Institute
🇺🇸Miami, Florida, United States
Florida Center for Cellular Therapy / Blood and Marrow Transplant Center
🇺🇸Orlando, Florida, United States
Florida Cancer Specialists - North Region
🇺🇸Saint Petersburg, Florida, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
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