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CD-30 Positive Anaplastic Large T-cell Cutaneous LymphomaPhase 2NCT01352520

SGN-35 in CD30-positive Lymphoproliferative Disorders (ALCL), Mycosis Fungoides (MF), and Extensive Lymphomatoid Papulosis (LyP)

A Phase 2 study testing SGN-35 in people with CD-30 Positive Anaplastic Large T-cell Cutaneous Lymphoma and Lymphoma, Primary Cutaneous Anaplastic Large Cell, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SGN-35
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteUnited States
Study dates
Jun 2011to 31 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase II Trial of Brentuximab Vedotin (SGN-35) at Dose of 1.8 mg/kg IV Every 3 Weeks in Patients With CD30-positive Lymphoproliferative Disorders (Cutaneous Anaplastic Large T-cell Lymphoma (ALCL), Mycosis Fungoides, and Extensive Lymphomatoid Papulosis (LyP)

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.

Read the detailed description

The Study Drug:

Brentuximab vedotin is an antibody that is designed to find a certain protein (called CD30) on cancer cells and bind to it. It is designed to then enter the cell and release a molecule that may kill the cancer cells.

Study Drug Administration:

If you are found eligible to take part in this study, you will begin receiving brentuximab vedotin by vein over 30 minutes on Day 1 of each 21-day study cycle. If you have side effects after your first dose and your doctor thinks it is in your best interest, future doses may be lowered or delayed for up to 3 weeks.

Premedications:

If you have any reactions at the infusion site after you receive the study drug during Cycle 1, you may be given acetaminophen (Tylenol) or diphenhydramine (Benadryl) 30-60 minutes before all following infusions.

Study Visits:

At each clinic visit, including follow-up visits (described below), you will have full skin exams. You will be checked to see how much of your skin's surface has lesions. Up to 6 skin lesions will be selected to be photographed and measured at each visit. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are lesions on your face. You will not be able to be identified in the photographs. The following tests and procedures will also be performed:

On Day 1 of all study cycles (before you receive the study drug):

  • You will have a physical exam.
  • Your performance status will be recorded.
  • You will be asked about any drugs that you may be taking and if you are having any side effects.
  • You will complete 5 questionnaires about your quality of life and itching symptoms.
  • Blood (about 4-6 teaspoons) will be drawn for routine tests and to check the status of the disease.
  • If you have not had a lesion biopsy within the last 6 weeks you will have a lesion biopsy to check the status of the disease and for PGx testing.

Length of Study Treatment:

You may receive the study drug for up to 8 cycles. You will be taken off study if the disease gets worse or intolerable side effects occur.

If the disease has a complete response, you may receive the study drug for 2 more cycles if the study doctor thinks it is in your best interest.

If the disease has complete response, then comes back, you may receive the study drug for 8 more cycles if the doctor thinks it is in your best interest.

If you are doing better at the end of 8 cycles but the disease is not in complete remission, the study doctor may allow you to receive the study drug every 3 weeks at the full dose or every 2 weeks at a lower dose for 8 additional cycles. If you continue to have improvement after these 16 cycles, the study doctor may allow you to continue receiving the study drug. The study doctor will discuss this with you.

Follow-up Visits:

About 3-4 weeks after you have stopped taking the study drug, the following tests and procedures will be performed:

  • Your medical history will be recorded.
  • Your performance status will be recorded.
  • You will have a physical exam.
  • You will be asked if you are having any side effects.
  • You will complete 5 questionnaires about your quality of life and itching symptoms.
  • Blood (about 4-6 teaspoons) will be drawn for routine tests and to check the status of the disease.
  • You will have a CT or PET scan to check the status of the disease.
  • You will have a lesion biopsy to check the status of the disease and for PGx testing.

Long-term Follow-up:

You or your primary doctor may be contacted for long-term follow-up on the status of the disease, any study-related nerve damage (including loss of motor or sensory function) you have, and your overall health status.

Follow-up will be every 12-16 weeks for the first 2 years after the last dose. Then, the follow-up will be every 6 months (+/- 1 month) up to a maximum period of 5 years.

This is an investigational study. Brentuximab vedotin is FDA approved and commercially available for use in patients with ALCL. It is currently being used for LyP and MF for research purposes only. You will receive $15 coupons for valet parking for each clinic visit you make during this study.

Up to 84 patients will take part in this study. All will be enrolled at MD Anderson.

Being tested
SGN-35
Keywords
systemic therapy, cutaneous anaplastic large T cell lymphoma, ALCL, lymphomatoid papulosis, LyP, mycosis fungoides, MF, SGN-35 (brentuximab vedotin), skin lymphomas, CD30-positive lymphoproliferative disorders, tumor lymphocytes, cutaneous lymphomas, CD30+ expression, Hematologic Disorder, Lymphoma
Medical subject headings
Lymphoma, Primary Cutaneous Anaplastic Large Cell, Lymphomatoid Papulosis, Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous, Lymphoma, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGN-35Drug

    Also called Brentuximab vedotin

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

Study groups in NCT01352520
Study groupRoleWhat they receive
SGN-35Experimental1.8 mg/kg intravenously Day 1 of 21-day cycle.
Receives: Drug: SGN-35

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (1)

  1. Time to Progression

    Time to progression calculated as the time (days) from date of first dose of study drug to date of first observed progression or death date if the death was due to disease progression whichever comes first.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2011 (estimated)
  2. Study startJun 2011
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01352520
Sponsor's protocol ID
2010-0914
Other IDs
NCI-2011-01045
Status last verified
Jul 2026
First submitted
10 May 2011
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 28980004

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SGN-35 in people with CD-30 Positive Anaplastic Large T-cell Cutaneous Lymphoma and Lymphoma, Primary Cutaneous Anaplastic Large Cell, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01352520, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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