Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18 - 75
Clinical summary
Summary
Hypomethylating agents (HMAs), such as decitabine or azacitidine, are considered a standard treatment for older patients with AML. The primary goal of this study is to test whether patients treated with an HMA (either decitabine or azacitidine) in combination with 33A will 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, remission rates, duration of remission, event free- and leukemia-free survival, and safety and tolerability will be compared between arms.
Conditions
This trial is treating people with Acute Myeloid Leukaemia
Eligibility
Inclusion
- 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
- 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)
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Seattle Genetics, Inc.
Scientific 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)
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