Clinical trial · Interventional
Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
A Randomized, Double-blind Phase 3 Study of Vadastuximab Talirine (SGN-CD33A) Versus Placebo in Combination With Azacitidine or Decitabine in the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to safety; specifically a higher rate of deaths, including fatal infections, in the SGN33A arm versus the control arm
Summary
Brief summary (as posted)
The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 33A | Drug | — | UNRESOLVED |
| azacitidine | Drug | Azacitidine | ALIAS |
| decitabine | Drug | Decitabine | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 33A + HMA
- description
- 33A plus azacitidine or decitabine
- interventionNames
- Drug: 33A
- Drug: azacitidine
- Drug: decitabine
- type
- ACTIVE_COMPARATOR
- label
- placebo + HMA
- description
- placebo plus azacitidine or decitabine
- interventionNames
- Drug: placebo
- Drug: azacitidine
- Drug: decitabine
Primary outcomes (2)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo or secondary AML according to World Health Organization (WHO) classification (except for acute promyelocytic leukemia (APL)) * Intermediate or adverse cytogenetic risk * Eligible for therapy with either decitabine or azacitidine * Acceptable hematologic and organ function Exclusion Criteria: * AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or t(15;17) * Patients who are candidates for allogeneic stem cell transplant at the time of enrollment * Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis * Received prior treatment with HMA or chemotherapy for antecedent myelodysplastic syndrome (MDS)
References
Publications (0)
Data not yet available