CASCADE (SGN33A-005) | Aplastic Anemia and MDS International Foundation

ClinicalTrials.gov Identifier:

NCT02785900

Company

Seattle Genetics

Contact Info

Seattle Genetics Trial Information Support

clinicaltrials@seagen.com

(866) 333-7436

Dates

Start: May 2016
End: September 2021

Official Title

CASCADE (SGN33A-005)

Purpose

The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine extends overall survival longer than placebo combined with either azacitidine or decitabine.

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Terminated
Phase: 
Phase 3
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
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

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