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

Phase 1

Conditions: Acute myeloid leukemia (AML)
MedDRA version: 19.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-003482-28-BE

Lead Sponsor: Seattle Genetics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

Ages Eligible for Study: 65 Years and older
Genders Eligible for Study: Both
Inclusion Criteria:
• Newly diagnosed, previously untreated, cytologically/histologically confirmed de
novo or secondary AML according to 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

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 MDS.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare overall survival (OS) between treatment arms;Secondary Objective: ? To compare the composite complete remission (CRc) rate (complete<br>remission [CR] and morphologic CR with incomplete hematologic<br>recovery [CRi]) between treatment arms<br>? To compare event-free survival (EFS) between treatment arms<br>? To evaluate the duration of remission in the 2 treatment arms<br>? To evaluate leukemia-free survival (LFS) in the 2 treatment arms<br>? To evaluate the safety profiles in the 2 treatment arms<br>? To evaluate the time to response in the 2 treatment arms<br>? To evaluate the 30- and 60-day mortality rates in the 2 treatment arms<br>? To evaluate minimal residual disease (MRD) status;Primary end point(s): Overall Survival ;Timepoint(s) of evaluation of this end point: Up to approximately 5 years.

Secondary Outcome Measures