This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT02785900
First received: May 25, 2016
Last updated: July 7, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Acute Myeloid Leukemia Drug: 33A Drug: placebo Drug: azacitidine Drug: decitabine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to approximately 5 years ]
  • Composite complete remission rate [ Time Frame: Up to approximately 5 years ]

Secondary Outcome Measures:
  • Minimal residual disease (MRD)-negative composite complete remission rate [ Time Frame: Through 1 month following last dose ]
  • Duration of remission [ Time Frame: Up to approximately 5 years ]
  • Event-free survival [ Time Frame: Up to approximately 5 years ]
  • Leukemia-free survival [ Time Frame: Up to approximately 5 years ]
  • Type, incidence, severity, seriousness, and relatedness of adverse events [ Time Frame: Through 1 month following last dose ]
  • Laboratory abnormalities [ Time Frame: Through 1 month following last dose] ]
  • Time to response [ Time Frame: Through 1 month following last dose ]
  • Mortality rates at Day 30 and Day 60 post the first study treatment [ Time Frame: Day 30 and Day 60 following the first dose ]

Enrollment: 240
Study Start Date: May 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 33A + HMA
33A plus azacitidine or decitabine
Drug: 33A
33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push
Other Name: vadastuximab talirine, SGN-CD33A
Drug: azacitidine
75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks
Drug: decitabine
20 mg/m2 given IV x 5 days, every 4 weeks
Active Comparator: placebo + HMA
placebo plus azacitidine or decitabine
Drug: placebo
Volume equivalent to 10 mcg/kg, every 4 weeks via IV push
Drug: azacitidine
75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks
Drug: decitabine
20 mg/m2 given IV x 5 days, every 4 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02785900

  Show 128 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Phoenix Ho, MD Seattle Genetics, Inc.
  More Information

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02785900     History of Changes
Other Study ID Numbers: SGN33A-005
2015-003482-28 ( EudraCT Number )
Study First Received: May 25, 2016
Last Updated: July 7, 2017

Keywords provided by Seattle Genetics, Inc.:
Antibodies, monoclonal
Antibody drug conjugate
Antigens, cluster of differentiation 33 (CD33)
Drug therapy
Immunotherapy

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Antibodies
Azacitidine
Decitabine
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017