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: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003482-28-CZ
• Lead Sponsor: Seattle Genetics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-18
• Last Update Posted: 23 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Ages Eligible for Study: 18 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) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 518

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