Clinical Trials /

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

NCT02785900

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Terminated

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02785900

Trial Eligibility

Document

Title

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

  • ORG STUDY ID: SGN33A-005
  • SECONDARY ID: 2015-003482-28
  • NCT ID: NCT02785900

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
33Avadastuximab talirine, SGN-CD33A33A + HMA
placeboplacebo + HMA
azacitidine33A + HMA
decitabine33A + HMA

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.

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.

Trial Arms

NameTypeDescriptionInterventions
33A + HMAExperimental33A plus azacitidine or decitabine
  • 33A
  • azacitidine
  • decitabine
placebo + HMAActive Comparatorplacebo plus azacitidine or decitabine
  • placebo
  • azacitidine
  • decitabine

Eligibility 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)
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival
Time Frame:Up to 1.5 years
Safety Issue:
Description:Time from randomization to death due to any cause

Secondary Outcome Measures

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

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Seagen Inc.

Trial Keywords

  • Antibodies, monoclonal
  • Antibody drug conjugate
  • Antigens, cluster of differentiation 33 (CD33)
  • Drug therapy
  • Immunotherapy

Last Updated

December 12, 2018