Clinical trial · Interventional
Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
NCT01461538CI-TRIAL-00021234completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
Conditions
Conditions (4)
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 Lymphoid Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Anemia, Refractory, With Excess of Blasts | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brentuximab vedotin | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Brentuximab vedotin 1.8 mg/kg
- description
- Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
- interventionNames
- Drug: brentuximab vedotin
- type
- EXPERIMENTAL
- label
- Brentuximab vedotin 2.4 mg/kg
- description
- Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
- interventionNames
- Drug: brentuximab vedotin
- type
- EXPERIMENTAL
- label
- Brentuximab vedotin 1.2 mg/kg
- description
- Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy * Have failed, refused, or have been deemed ineligible for standard therapy * Measurable disease * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70 Exclusion Criteria: * Primary diagnosis of lymphoma or central nervous system (CNS) malignancy * History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years * Evidence of active cerebral/meningeal disease
References
Publications (3)
- DERIVEDAlbany C, Einhorn L, Garbo L, Boyd T, Josephson N, Feldman DR. Treatment of CD30-Expressing Germ Cell Tumors and Sex Cord Stromal Tumors with Brentuximab Vedotin: Identification and Report of Seven Cases. Oncologist. 2018 Mar;23(3):316-323. doi: 10.1634/theoncologist.2017-0544. Epub 2017 Dec 8. PMID 29222199
- DERIVEDBorate U, Mehta A, Reddy V, Tsai M, Josephson N, Schnadig I. Treatment of CD30-positive systemic mastocytosis with brentuximab vedotin. Leuk Res. 2016 May;44:25-31. doi: 10.1016/j.leukres.2016.02.010. Epub 2016 Feb 27. PMID 26994848
- DERIVEDGiannatempo P, Paolini B, Miceli R, Raggi D, Nicolai N, Fare E, Catanzaro M, Biasoni D, Torelli T, Stagni S, Piva L, Mariani L, Salvioni R, Colecchia M, Gianni AM, Necchi A. Persistent CD30 expression by embryonal carcinoma in the treatment time course: prognostic significance of a worthwhile target for personalized treatment. J Urol. 2013 Nov;190(5):1919-24. doi: 10.1016/j.juro.2013.04.057. Epub 2013 Apr 25. PMID 23624209