Clinical trial · Interventional
Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level
Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level
NCT01396070CI-TRIAL-00026790completedPhase 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)
The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Lymphoma | Cutaneous Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Cutaneous T-cell Lymphoma (CTCL) | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.85 |
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin Lymphoma (NHL) | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Sezary Syndrome | Sezary Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab vedotin | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brentuximab vedotin
- description
- Novel antibody-drug conjugate, 1.8 mg/kg intravenously every 3 weeks
- interventionNames
- Drug: Brentuximab vedotin
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 2 years
- description
- Overall response rate of brentuximab vedotin in this study population.
Secondary outcomes (3)
- measure
- Overall Stable Disease Rate
- timeFrame
- 2 years
- description
- Overall Stable Disease Rate (SD) in this study population. 3 subjects were not evaluable.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven MF/SS, stage IB-IVB, and failed one standard systemic therapy. Skin biopsy must be within 3 months of beginning study medication * At least the following wash-out from prior treatments: * ≥ 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-cancer investigational agents (including monoclonal antibody) * \> 3 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox and phototherapy * \> 2 wks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod) * At least 18 years of age * ECOG performance status of ≤ 2 * Must be able to commit to study schedule * Absolute neutrophil count (ANC) ≥ 1000/uL * Platelets ≥ 50,000/uL * Bilirubin ≤ 2X upper limit of normal (ULN) (EXCEPTION: Gilbert's disease ≤ 3X ULN) * Serum creatinine ≤ 2X ULN * Alanine aminotransferase (ALT) ≤ 3X ULN * Aspartate aminotransferase (AST) ≤ 3X ULN * Negative serum beta-HCG pregnancy test result within 7 days of first treatment, if a woman of childbearing potential * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Mycosis fungoides (MF) with limited disease (stage IA) or central nervous system (CNS) disease * Systemic or topical concomitant corticosteroid use for treatment of skin disease (EXCEPTION: Oral prednisone allowed at ≤ 10 mg/day) * Known Grade 3 or higher (per NCI CTCAE v4.0 criteria) active systemic or cutaneous viral, bacterial, or fungal infection * Known to be Hepatitis B or Hepatitis C antibody positive * HIV-positive with have a measurable viral load while on antiretroviral medication * Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation. * History of other malignancies during the past 3 years (EXCEPTIONS: non-melanoma skin cancer; curatively treated localized prostate cancer; curatively treated localized breast cancer; resected thyroid cancer; cervical intraepithelial neoplasia; or cervical carcinoma in situ on biopsy). * Pregnant * Breastfeeding * Congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria. * Any serious underlying medical condition that would impair subject's ability to receive or tolerate the planned treatment. * Dementia or altered mental status that would preclude subject's understanding and rendering of informed consent.
References
Publications (1)
- DERIVEDKim YH, Tavallaee M, Sundram U, Salva KA, Wood GS, Li S, Rozati S, Nagpal S, Krathen M, Reddy S, Hoppe RT, Nguyen-Lin A, Weng WK, Armstrong R, Pulitzer M, Advani RH, Horwitz SM. Phase II Investigator-Initiated Study of Brentuximab Vedotin in Mycosis Fungoides and Sezary Syndrome With Variable CD30 Expression Level: A Multi-Institution Collaborative Project. J Clin Oncol. 2015 Nov 10;33(32):3750-8. doi: 10.1200/JCO.2014.60.3969. Epub 2015 Jul 20. PMID 26195720