This study will examine the safety and anti-leukemic profile of SGN-CD33A (vadastuximab talirine) in patients with relapsed chemo-resistant AML, who are given vadastuximab talirine in sequence with standard treatments before a planned stem cell transplant, or as maintenance therapy after a stem cell transplant. The main purpose of the study is to find the best dose and determine the anti-leukemic activity of vadastuximab talirine, given either pre- or post-allogeneic stem cell transplant (alloSCT) for adults with relapsed or refractory AML. This will be determined by assessing the safety and tolerability of vadastuximab talirine. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan 140 mg/m2 intravenously, 2 days before the transplant
Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
Post-allo (after stem cell transplant) given on Day 1 of each cycle
City of Hope National Medical Center
Duarte, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Case Western Reserve University / University Hospitals Case Medical Center
Cleveland, Ohio, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
...and 1 more locations
Incidence of Adverse Events
AE: Adverse events; TEAE: Treatment-emergent adverse event. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. An AE is considered serious if it was fatal, life threatening, required hospitalization, was disabling/incapacitating, resulted in a birth defect or congenital anomally, or was otherwise considered to be medically significant.
Time frame: Approximately 1 year
Incidence of Laboratory Abnormalities
Number (count) of participants that experienced a Grade 3 or higher laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
Time frame: Approximately 1 year
1-year Survival Rate
1-year survival rate estimated using Kaplan-Meier methods The start date for overall survival is the day of alloSCT.
Time frame: 12 months
Rate of MRD Negativity
Rate of MRD (minimal residual disease) negativity at Day -1 (1 day prior to transplant) and Day 30 post-transplant (Part A only)
Time frame: 30 days
Best Response of CR or CRi
Percentage of patients who achieved a best response of CRi (complete remission with incomplete blood count recovery) or CR (complete remission)
Time frame: 9 weeks
Duration of Response
Defined as the time from the start of the first documented complete response (CR) or complete remission with incomplete blood count recovery (CRi) to the documentation of relapse or death due to any cause.
Time frame: 9 weeks
Overall Survival
Defined as the time from the day of alloSCT to the date of death due to any cause.
Time frame: Approximately 96 weeks
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