Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS
- Conditions
- Myelodysplastic Syndrome
- Interventions
- Registration Number
- NCT02706899
- Lead Sponsor
- Seagen Inc.
- Brief Summary
This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).
- Detailed Description
In the phase 1 portion of the study, escalating doses of 33A will be evaluated in combination with azacitidine, and a dose of 33A will be selected to proceed to phase 2. The phase 2 portion of the study is randomized, double-blind and placebo-controlled; it is designed to compare the overall response rate (ORR) between 2 study arms.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
- Subjects with cytologically/histologically confirmed MDS according to the World Health Organization (WHO) 2008 classification.
- Previously untreated for Myelodysplastic Syndrome (MDS)
- Age ≥18 years of age.
- Eligible for therapy with azacitidine.
- Life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Adequate baseline laboratory parameters.
- Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs).
- History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
- Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).
- Candidates for allogeneic stem cell transplant at the time of screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + azacitidine Placebo (for 33A) placebo plus azacitidine 33A + azacitidine vadastuximab talirine Vadastuximab talirine plus azacitidine 33A + azacitidine Azacitidine Vadastuximab talirine plus azacitidine Placebo + azacitidine Azacitidine placebo plus azacitidine
- Primary Outcome Measures
Name Time Method Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study Up to 1 year A recommended dose of vadastuximab talirine was not identified in Phase 1 due to study termination. Number of dose delays and reductions are reported in lieu of a dose recommendation.
Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study N/A - End point not assessed
- Secondary Outcome Measures
Name Time Method Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities Up to 1 year As defined by the number of participants with adverse events and laboratory abnormalities. Participants are included only once per row, even if the participant experienced multiple events applicable to the category.
Complete Response Rate (CR) N/A - End point not assessed Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the CR rate, as defined by the 2006 IWG criteria for MDS.
Duration of Response (DOR) Rate N/A - End point not assessed Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first observation of response (CR, PR, or Marrow CR) to disease progression/relapse or death from any cause, whichever occurs first.
Overall Survival (OS) N/A - End point not assessed Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to death due to any cause.
Hematologic Improvement (HI) Rate N/A - End point not assessed Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the HI rate, as defined by the 2006 IWG criteria for MDS.
Progression Free Survival (PFS) N/A - End point not assessed Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.
Rate of Transformation to Acute Myeloid Leukemia (AML) N/A - End point not assessed Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the rate of transformation to AML after initiation of study therapy.
Trial Locations
- Locations (34)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Case Western Reserve University (CWRU) - University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Georgia Regents University Hospital
🇺🇸Augusta, Georgia, United States
Cancer Specialisits of North Florida
🇺🇸Fleming Island, Florida, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Texas Oncology - Austin Midtown
🇺🇸Austin, Texas, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
The University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Providence Portland Research Center
🇺🇸Portland, Oregon, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
University of Colorado Hospital
🇺🇸Denver, Colorado, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
Rocky Mountain Cancer Centers, LLP
🇺🇸Aurora, Colorado, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Minnesota Medical Center (UMMC)
🇺🇸Minneapolis, Minnesota, United States
Bozeman Deaconess Health Group
🇺🇸Bozeman, Montana, United States
Weill Cornell
🇺🇸Brooklyn, New York, United States
Westchester Medical Center
🇺🇸Hawthorne, New York, United States
University of Pennsylvania, Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Oregon Health & Science
🇺🇸Portland, Oregon, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Froedtert & Medical College of Wisconson Clinical Cancer Center
🇺🇸Milwaukee, Wisconsin, United States