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NCT02785900 Clinical Trial

Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

— CASCADE  

Official title:
A Randomized, Double-blind Phase 3 Study of Vadastuximab Talirine (SGN-CD33A) Versus Placebo in Combination With Azacitidine or Decitabine in the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02785900
Other study ID # SGN33A-005
Secondary ID 2015-003482-28
Status Terminated
Phase Phase 3
First received
Last updated
Start date May 2016
Est. completion date October 3, 2017

Study information
Verified date November 2018
Source Seattle Genetics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 33A
33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push
• placebo
Volume equivalent to 10 mcg/kg, every 4 weeks via IV push
• azacitidine
75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks
• decitabine
20 mg/m2 given IV x 5 days, every 4 weeks
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Sponsors (1)
Lead Sponsor Collaborator
Seattle Genetics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Luxembourg,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival Time from randomization to death due to any cause Up to 1.5 years
Primary Composite Complete Remission (CRc) Rate 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. Up to 1.5 years
Secondary Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate Number of patients who achieve both remission (CR or CRi) and MRD-negative status Up to 1.5 years
Secondary Duration of Remission 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. Up to approximately 9.5 months
Secondary Event-free Survival 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. Up to approximately 11.24 months
Secondary Leukemia-free Survival 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. Up to approximately 9.49 months
Secondary Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events 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. Up to 1.5 years
Secondary Incidence of Grade 3 or Higher Laboratory Abnormalities 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) Up to 1.5 years
Secondary Time to Complete Remission Time to CR or CRi is the time from randomization to the first documentation of CR/CRi Up to 1.5 years
Secondary Mortality Rates at Day 30 and Day 60 30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method. Up to 60 days
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