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

Myelodysplastic Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02706899
• Other study ID #: SGN33A-004
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 2016
• Est. completion date: November 6, 2017

Study information

• Verified date: January 2019
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: November 6, 2017
• Est. primary completion date: November 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• vadastuximab talirine
Intravenous (IV) push every 4 weeks
• Azacitidine
75 mg/m^2 given intravenously or subcutaneously for 7 days every 4 weeks
• Placebo (for 33A)
Placebo supplied in single-use vials matching 33A, IV push every 4 weeks

Locations

Country	Name	City	State
United States	The University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Georgia Regents University Hospital	Augusta	Georgia
United States	Rocky Mountain Cancer Centers, LLP	Aurora	Colorado
United States	Texas Oncology - Austin Midtown	Austin	Texas
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Bozeman Deaconess Health Group	Bozeman	Montana
United States	Weill Cornell	Brooklyn	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Case Western Reserve University (CWRU) - University Hospitals Case Medical Center	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	University of Colorado Hospital	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Cancer Specialisits of North Florida	Fleming Island	Florida
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Westchester Medical Center	Hawthorne	New York
United States	MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Southern California	Los Angeles	California
United States	Froedtert & Medical College of Wisconson Clinical Cancer Center	Milwaukee	Wisconsin
United States	University of Minnesota Medical Center (UMMC)	Minneapolis	Minnesota
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	University of Pennsylvania, Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Oregon Health & Science	Portland	Oregon
United States	Providence Portland Research Center	Portland	Oregon
United States	Cancer Care Centers of South Texas	San Antonio	Texas
United States	Swedish Medical Center	Seattle	Washington
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 year
Primary	Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study		N/A - End point not assessed
Secondary	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.	Up to 1 year
Secondary	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.	N/A - End point not assessed
Secondary	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.	N/A - End point not assessed
Secondary	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.	N/A - End point not assessed
Secondary	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.	N/A - End point not assessed
Secondary	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.	N/A - End point not assessed
Secondary	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.	N/A - End point not assessed