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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02706899
Recruitment Status : Terminated (Sponsor decision based on portfolio prioritization)
First Posted : March 11, 2016
Results First Posted : December 21, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, 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).

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: vadastuximab talirine Drug: Azacitidine Drug: Placebo (for 33A) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2016
Actual Primary Completion Date : November 6, 2017
Actual Study Completion Date : November 6, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine

Arm Intervention/treatment
Experimental: 33A + azacitidine
Vadastuximab talirine plus azacitidine
Drug: vadastuximab talirine
Intravenous (IV) push every 4 weeks
Other Names:
  • 33A
  • SGN-CD33A

Drug: Azacitidine
75 mg/m^2 given intravenously or subcutaneously for 7 days every 4 weeks

Active Comparator: Placebo + azacitidine
placebo plus azacitidine
Drug: Azacitidine
75 mg/m^2 given intravenously or subcutaneously for 7 days every 4 weeks

Drug: Placebo (for 33A)
Placebo supplied in single-use vials matching 33A, IV push every 4 weeks




Primary Outcome Measures :
  1. Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study [ Time Frame: 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.

  2. 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 Measures :
  1. Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities [ Time Frame: 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.

  2. Complete Response Rate (CR) [ Time Frame: 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.

  3. Hematologic Improvement (HI) Rate [ Time Frame: 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.

  4. Duration of Response (DOR) Rate [ Time Frame: 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.

  5. Progression Free Survival (PFS) [ Time Frame: 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.

  6. Rate of Transformation to Acute Myeloid Leukemia (AML) [ Time Frame: 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.

  7. Overall Survival (OS) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706899


Locations
Show Show 34 study locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Chair: Phillip Garfin Seattle Genetics, Inc.
  Study Documents (Full-Text)

Documents provided by Seattle Genetics, Inc.:
Study Protocol  [PDF] April 13, 2017
Statistical Analysis Plan  [PDF] January 11, 2018

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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02706899    
Other Study ID Numbers: SGN33A-004
First Posted: March 11, 2016    Key Record Dates
Results First Posted: December 21, 2018
Last Update Posted: February 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Seattle Genetics, Inc.:
Antibody-Drug Conjugate CD33 Antigen
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors