NCT01352520

Brief Summary

The goal of this clinical research study is to learn if SGN-35 (brentuximab vedotin) can help to control ALCL, LyP or MF in patients with at least 1 of the 3 skin lymphomas. The safety of the study drug will also be studied.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for phase_2

Timeline
21mo left

Started Jun 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jun 2011Jan 2028

First Submitted

Initial submission to the registry

May 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
16.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

16.7 years

First QC Date

May 10, 2011

Last Update Submit

January 16, 2026

Conditions

CD-30 Positive Anaplastic Large T-cell Cutaneous LymphomaLymphomaLymphoma, Primary Cutaneous Anaplastic Large CellLymphomatoid PapulosisMycosis FungoidesSkin LymphomaCutaneous LymphomasHematologic Disorder

Keywords

systemic therapycutaneous anaplastic large T cell lymphomaALCLlymphomatoid papulosisLyPmycosis fungoidesMFSGN-35 (brentuximab vedotin)skin lymphomasCD30-positive lymphoproliferative disorderstumor lymphocytescutaneous lymphomasCD30+ expressionHematologic DisorderLymphoma

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    Response rate is percentage of participants with skin lesions that express CD30+ receiving SGN-35 in primary cutaneous ALCL, MF, and extensive lymphomatoid papulosis whose best response during the observation period is a Partial Response (PR), regression of measurable disease, or Complete Response (CR), complete disappearance of all clinical evidence of disease, (i.e. at least moderate improvement). Objective tumor response (PR, CR, PR+CR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

    12 months

Secondary Outcomes (1)

  • Time to Progression

    Assessments through 8 treatment cycles (21 day cycle, approximately 6 months) with possible expansion to 16 cycles, up to 2 years.

Study Arms (1)

SGN-35

EXPERIMENTAL

1.8 mg/kg intravenously Day 1 of 21-day cycle.

Drug: SGN-35

Interventions

SGN-35DRUG

1.8 mg/kg administered by outpatient IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle.

Also known as: Brentuximab vedotin
SGN-35

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have a biopsy confirmed diagnosis based on a combination of histological and clinical criteria of CD30+ lymphomatoid papulosis, CD30+ primary cutaneous anaplastic large T-cell lymphoma (pc-ALCL), or CD30+ mycosis fungoides for the phase II trial. There is no specific limit or validated amount other than positive cells on 1HC cells in tumor cells.
  • Patients with pc-ALCL that has spread systemically (e.g. to lymph nodes, bone marrow or visceral organs) may be included so long as pc-ALCL was the primary diagnosis for at least 6 months before systemic involvement was confirmed. MF patients must be stage IB or greater.
  • Systemic involvement (i.e., nodal, bone marrow or visceral organ involvement) will be evaluated by CT and/or PET and bone marrow biopsy(if indicated on patients with blood involvement) in patients with pc-ALCL or MF at baseline.
  • Patients' biopsies must be histologically confirmed CD30 positive within 36 months of enrollment.
  • pc-ALCL and MF patients must have progressed or relapsed after treatment with local radiation therapy, phototherapy, topical chemotherapy, or have failed systemic therapy of at least one single agent (e.g., methotrexate or bexarotene or other non-CD30 antibody) or one multi-agent chemotherapy (e.g. CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone). pc-ALCL classified patients are required to have one or more cutaneous tumors that by history have been present for at least 3 months.
  • All patients must be considered an eligible candidate for systemic therapy as determined by the investigator. To be eligible, LYP patients must be in need of systemic therapy ie have scarring or active lesions (\>/=10 per month), or any number of active lesions on face, hands or feet.
  • Patients must have the following minimum wash-out from previous treatments: a. \>/= 4 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anticancer investigational agents. b. \> 2 weeks for oral methotrexate, retinoids or biological response modifiers therapy for any indication, or topical prescription or topical therapy. c. \>/= 12 weeks for any immunotherapy (e.g., monoclonal antibody). Patients with rapidly progressive disease may be treated earlier than the required washout period; patients should have recovered from prior treatment-related toxicities
  • Patients must have an ECOG performance status of \</= 2.
  • Patients must be at least 18 years of age.
  • Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
  • Females of childbearing potential \[a female not post menopausal for at least 12 months or not surgically sterilized\] must have a negative beta-HCG pregnancy \</=7 days prior to Day 1 of Cycle 1. If the pregnancy test is outside institutional normal range at pretreatment, the subject must have a second pregnancy test. If the second pregnancy test is outside institutional normal range then a gynecology consult is needed to confirm the subject is not pregnant. All patients must agree to use an effective contraceptive method during the course of the study.
  • Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient's chart.
  • The following required baseline laboratory data: absolute neutrophil count (ANC) \>/= 1000/microliter, platelets \>/= 50,000/µL (unless documented bone marrow involvement with lymphoma), bilirubin \</= 1.5X upper limit of normal (ULN) or \</= 3X ULN for patients with Gilbert's disease, serum creatinine \</= 1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \</= 2.5X ULN.

You may not qualify if:

  • Concomitant corticosteroid use for systemic or topical treatment of skin disease is not allowed except a dose of steroid of no more than 20 mg of prednisone or its equivalence is allowed of asthma, COPD or IBD .Stable use of topical corticosteroids of mid-potency will be allowed for patients with erythroderma-Sezary syndrome (T4) and tumor stage (T3) with intense pruritus.
  • Patients with known grade 3 or higher (per CTCAE v.4.0 criteria) active systemic or cutaneous viral, bacterial or fungal infection.
  • Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
  • Patients with known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation that includes trehalose, sodium citrate, and polysorbate 80.
  • Patient with a history of other malignancies during the past three years. (The following are exempt from the 3-year limit: non-melanoma skin cancer, melanoma in situ, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
  • Patients with congestive heart failure, Class III or IV, by the NYHA criteria.
  • Patients who are pregnant or breastfeeding.
  • Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
  • Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Lewis DJ, Talpur R, Huen AO, Tetzlaff MT, Duvic M. Brentuximab Vedotin for Patients With Refractory Lymphomatoid Papulosis: An Analysis of Phase 2 Results. JAMA Dermatol. 2017 Dec 1;153(12):1302-1306. doi: 10.1001/jamadermatol.2017.3593.

    PMID: 28980004DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Primary Cutaneous Anaplastic Large CellLymphomatoid PapulosisMycosis FungoidesLymphoma, T-Cell, CutaneousLymphomaHematologic Diseases

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Auris O Huen, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 12, 2011

Study Start

June 1, 2011

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

US(1)