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

Seagen

Status and phase: Terminated; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: azacitidine; Drug: 33A; Drug: placebo; Drug: decitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02785900

SGN33A-005

2015-003482-28 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

33A + HMA

Experimental group

Description:

33A plus azacitidine or decitabine

Treatment:

Drug: azacitidine

Drug: decitabine

Drug: 33A

placebo + HMA

Active Comparator group

Description:

placebo plus azacitidine or decitabine

Treatment:

Drug: placebo

Drug: azacitidine

Drug: decitabine