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18d
TAGVEN: Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients (clinicaltrials.gov)
P2, N=33, Recruiting, French Innovative Leukemia Organisation | Not yet recruiting --> Recruiting | Trial primary completion date: Jan 2026 --> Dec 2028
Enrollment open • Trial primary completion date
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Venclexta (venetoclax) • Elzonris (tagraxofusp-erzs)
22d
Vibecotamab for measurable residual disease in acute myeloid leukemia and for myelodysplastic syndromes and chronic myelomonocytic leukemia after hypomethylating agent failure: a phase II study. (PubMed, J Hematol Oncol)
Vibecotamab was active in low-blast myeloid diseases, although the durability of responses was modest. Additional studies of CD123-targeting bispecific antibodies, alone or in combination, are warranted for these diseases.
P2 data • Journal
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CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
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vibecotamab (XmAb14045)
24d
GO-TAG: Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML (clinicaltrials.gov)
P1, N=7, Terminated, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | N=36 --> 7 | Trial completion date: Dec 2028 --> Jul 2025 | Active, not recruiting --> Terminated; Upon analysis of the first 7 participants accrued, it was determined that this combination treatment is not efficacious as treatment for patients with relapsed or refractory AML
Enrollment change • Trial completion date • Trial termination
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CD33 (CD33 Molecule) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
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Mylotarg (gemtuzumab ozogamicin) • Elzonris (tagraxofusp-erzs)
25d
Tagraxofusp in adult blastic plasmacytoid dendritic cell neoplasm: clinical trials and real-world outcomes: a systematic review. (PubMed, Front Immunol)
Long-term survival appears strongly influenced by successful bridging to HSCT. Evidence remains predominantly non-randomized, underscoring the need for comparative and combination studies.
Review • Journal • Real-world evidence
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CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
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Elzonris (tagraxofusp-erzs)
1m
MP0533-CP101: Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
P1/2, N=249, Active, not recruiting, Molecular Partners AG | Recruiting --> Active, not recruiting | Trial completion date: Dec 2029 --> May 2027 | Trial primary completion date: Dec 2027 --> May 2026
Enrollment closed • Trial completion date • Trial primary completion date • First-in-human
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Venclexta (venetoclax) • azacitidine • Gazyva (obinutuzumab) • MP0533
1m
PEPN1812: Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=16, Active, not recruiting, Children's Oncology Group | Trial completion date: Mar 2026 --> Dec 2026
Trial completion date
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cytarabine • flotetuzumab (MGD006) • Starasid (cytarabine ocfosfate)
2ms
Shared Care Offers an Effective Framework for Managing Tagraxofusp Treatment in Blastic Plasmacytoid Dendritic Cell Neoplasm. (PubMed, Acta Haematol)
Key Messages: Shared care is particularly suitable for tagraxofusp treatment, as adverse events can be grade 3 or greater, but typically only occur in cycle 1, if they are to occur at all. Based on clinical experience, this article discusses the application of a shared-care model for tagraxofusp treatment in BPDCN.
Review • Journal
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CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
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Elzonris (tagraxofusp-erzs)
2ms
NCI-2022-02215: A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure (clinicaltrials.gov)
P2, N=51, Terminated, M.D. Anderson Cancer Center | Trial completion date: Dec 2026 --> May 2026 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2026 --> May 2026; <75% participation
Trial completion date • Trial termination • Trial primary completion date • Minimal residual disease
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IL3RA (Interleukin 3 Receptor Subunit Alpha)
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vibecotamab (XmAb14045)
3ms
New P1/2 trial
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vibecotamab (XmAb14045)
3ms
TAGALONG: Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents (clinicaltrials.gov)
P2, N=53, Recruiting, Joshua Zeidner | Trial completion date: Dec 2027 --> Jul 2031 | Trial primary completion date: Aug 2027 --> Jul 2030
Trial completion date • Trial primary completion date
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IL3RA (Interleukin 3 Receptor Subunit Alpha)
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Venclexta (venetoclax) • azacitidine • Elzonris (tagraxofusp-erzs)
4ms
New P3 trial
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EGFR (Epidermal growth factor receptor)
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Meiyouheng (becotatug vedotin) • becotarug (JMT101) • vibecotamab (XmAb14045)