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

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.

Inclusion Criteria:

1. 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.

2. 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.

3. 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.

4. Patients' biopsies must be histologically confirmed CD30 positive within 36 months of
enrollment.

5. 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.

6. 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.

7. 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

8. Patients must have an ECOG performance status of
9. Patients must be at least 18 years of age.

10. Patients must be available for periodic blood sampling, study-related assessments, and
management of toxicity at the treating institution.

11. 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 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.

12. Patients must give written informed consent. A copy of the signed informed consent
form will be retained in the patient's chart.

13. The following required baseline laboratory data: absolute neutrophil count (ANC) >/=
1000/microliter, platelets >/= 50,000/µL (unless documented bone marrow involvement
with lymphoma), bilirubin patients with Gilbert's disease, serum creatinine aminotransferase (ALT) and aspartate aminotransferase (AST)
Exclusion Criteria:

1. 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.

2. Patients with known grade 3 or higher (per CTCAE v.4.0 criteria) active systemic or
cutaneous viral, bacterial or fungal infection.

3. Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.

4. Patients with known hypersensitivity to recombinant proteins or any excipient
contained in the drug formulation that includes trehalose, sodium citrate, and
polysorbate 80.

5. 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.)

6. Patients with congestive heart failure, Class III or IV, by the NYHA criteria.

7. Patients who are pregnant or breastfeeding.

8. Patients with any serious underlying medical condition that would impair their ability
to receive or tolerate the planned treatment.

9. Patients with dementia or altered mental status that would preclude understanding and
rendering of informed consent.