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9L-16-4-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)

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.

Phase

Phase 1/2 - for trials that are a combination of phases 1 and 2.

Inclusion and Exclusion 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.

  • 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

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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