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Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS

Primary Purpose

Myelodysplastic Syndrome

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
vadastuximab talirine
Azacitidine
Placebo (for 33A)
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Antibody-Drug Conjugate CD33 Antigen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Banner MD Anderson Cancer Center
  • University of Southern California
  • Rocky Mountain Cancer Centers, LLP
  • Colorado Blood Cancer Institute
  • University of Colorado Hospital
  • Cancer Specialisits of North Florida
  • Mayo Clinic
  • Georgia Regents University Hospital
  • Rush University Medical Center
  • Center for Cancer and Blood Disorders
  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute
  • University of Minnesota Medical Center (UMMC)
  • Bozeman Deaconess Health Group
  • Hackensack University Medical Center
  • The University of New Mexico Cancer Research and Treatment Center
  • Weill Cornell
  • Westchester Medical Center
  • Columbia University Medical Center
  • University of North Carolina at Chapel Hill
  • Wake Forest Baptist Health
  • Case Western Reserve University (CWRU) - University Hospitals Case Medical Center
  • Ohio State University
  • Providence Portland Research Center
  • Oregon Health & Science
  • University of Pennsylvania, Abramson Cancer Center
  • Medical University of South Carolina
  • Tennessee Oncology, PLLC
  • Texas Oncology - Austin Midtown
  • Baylor University Medical Center
  • MD Anderson Cancer Center
  • Cancer Care Centers of South Texas
  • Swedish Medical Center
  • Froedtert & Medical College of Wisconson Clinical Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

33A + azacitidine

Placebo + azacitidine

Arm Description

Vadastuximab talirine plus azacitidine

placebo plus azacitidine

Outcomes

Primary Outcome Measures

Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
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

Secondary Outcome Measures

Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
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)
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.
Hematologic Improvement (HI) Rate
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.
Duration of Response (DOR) Rate
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.
Progression Free Survival (PFS)
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)
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.
Overall Survival (OS)
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.

Full Information

First Posted
February 19, 2016
Last Updated
January 23, 2019
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02706899
Brief Title
Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS
Official Title
A Phase 1/2 Study of Vadastuximab Talirine (SGN-CD33A) in Combination With Azacitidine in Patients With Previously Untreated International Prognostic Scoring System (IPSS) Intermediate-2 or High Risk Myelodysplastic Syndrome (MDS)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on portfolio prioritization
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 6, 2017 (Actual)
Study Completion Date
November 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
Antibody-Drug Conjugate CD33 Antigen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
33A + azacitidine
Arm Type
Experimental
Arm Description
Vadastuximab talirine plus azacitidine
Arm Title
Placebo + azacitidine
Arm Type
Active Comparator
Arm Description
placebo plus azacitidine
Intervention Type
Drug
Intervention Name(s)
vadastuximab talirine
Other Intervention Name(s)
33A, SGN-CD33A
Intervention Description
Intravenous (IV) push every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
75 mg/m^2 given intravenously or subcutaneously for 7 days every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo (for 33A)
Intervention Description
Placebo supplied in single-use vials matching 33A, IV push every 4 weeks
Primary Outcome Measure Information:
Title
Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
Description
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.
Time Frame
Up to 1 year
Title
Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study
Time Frame
N/A - End point not assessed
Secondary Outcome Measure Information:
Title
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
Description
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.
Time Frame
Up to 1 year
Title
Complete Response Rate (CR)
Description
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.
Time Frame
N/A - End point not assessed
Title
Hematologic Improvement (HI) Rate
Description
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.
Time Frame
N/A - End point not assessed
Title
Duration of Response (DOR) Rate
Description
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.
Time Frame
N/A - End point not assessed
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
N/A - End point not assessed
Title
Rate of Transformation to Acute Myeloid Leukemia (AML)
Description
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.
Time Frame
N/A - End point not assessed
Title
Overall Survival (OS)
Description
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.
Time Frame
N/A - End point not assessed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip Garfin
Organizational Affiliation
Seagen Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Rocky Mountain Cancer Centers, LLP
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
Country
United States
Facility Name
University of Colorado Hospital
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Cancer Specialisits of North Florida
City
Fleming Island
State/Province
Florida
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Georgia Regents University Hospital
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
University of Minnesota Medical Center (UMMC)
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Bozeman Deaconess Health Group
City
Bozeman
State/Province
Montana
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
The University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Weill Cornell
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Westchester Medical Center
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Case Western Reserve University (CWRU) - University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Providence Portland Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Oregon Health & Science
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania, Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Texas Oncology - Austin Midtown
City
Austin
State/Province
Texas
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Froedtert & Medical College of Wisconson Clinical Cancer Center
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS

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