Phase 2 N=36 Treatment

Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level

Non-Hodgkin Lymphoma (NHL) · Cutaneous Lymphoma · Cutaneous T-cell Lymphoma (CTCL) · Mycosis Fungoides · Sezary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01396070 ↗

Enrolled (actual)

Serious AEs

63.9%

Results posted

Apr 2017

Primary outcome: Primary: Overall Response Rate (ORR) — 70; 56; 79; 100 percentage

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Brentuximab vedotin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Youn Kim
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Response Rate (ORR)	70; 56; 79; 100; 83; 94	—
SECONDARY Overall Stable Disease Rate	5	—
SECONDARY Overall Partial Response Rate	21	—
SECONDARY Overall Non-Evaluable Response	4	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01396070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.