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

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ClinicalTrials.gov Identifier: NCT02706899
Recruitment Status : Terminated
First Posted : March 11, 2016
Last Update Posted : January 5, 2018
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.

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
Other Names:
  • 33A
  • SGN-CD33A

Drug: Azacitidine
azacitidine 75 mg/m2 given intravenously or subcutaneously x 7 days every 4 weeks

Active Comparator: Placebo + azacitidine
placebo plus azacitidine
Drug: Azacitidine
azacitidine 75 mg/m2 given intravenously or subcutaneously x 7 days every 4 weeks

Drug: Placebo (for 33A)
Placebo supplied in single-use vials matching 33A




Primary Outcome Measures :
  1. Phase 1 Outcome Measure: Recommended dose of vadastuximab talirine for the Phase 2 portion of the study [ Time Frame: Through completion of the Phase 1 portion of the study up to a maximum of 18 months. (1 cycle = 28 days). ]
  2. Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 portion of the study [ Time Frame: Response assessments will be conducted once between Day 22 and Day 29 of even-numbered cycles until CR, then every 4 cycles thereafter for up to 6 months.(1 cycle = 28 days.) ]
    Overall Response rate will be assessed by the investigator as the proportion of subjects who achieve a category of Complete Response (CR and Marrow CR) or Partial Response (PR) based on the 2006 International Working Group (IWG) criteria for MDS.


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: through 1 month following last dose. ]
    As defined by the number of participants with Adverse Events and laboratory abnormalities.

  2. Complete Response Rate (CR) [ Time Frame: Up to 6 months. ]
    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: Up to 6 months ]
    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: Up to 3 years ]
    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: Up to 3 years ]
    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: Up to 3 years ]
    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: Up to 4 years ]
    A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to death due to any cause.



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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


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Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Chair: Phillip Garfin Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02706899     History of Changes
Other Study ID Numbers: SGN33A-004
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
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:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors