Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT)

Study Drug Administration:

If you agree to take part in this study, about 35-60 days after the transplant, you will
receive brentuximab vedotin by vein over about 30 minutes on Day 1 of each 21-day study
cycle. You may receive up to 6 cycles of brentuximab vedotin.

At Cycles 3 and beyond, you will receive a higher dose of the study drug than you received
during Cycles 1 and 2.

Study Visits:

About 5 days before Day 1 of Cycle 1:

- You will have a physical exam. As part of the physical exam, you will be checked for
graft-versus-host disease (GVHD -- when transplanted donor tissue attacks the tissues of
the recipient's body). You may have an additional blood draw to check for GVHD as part
of your standard of care.

- Blood (about 2 tablespoons) will be drawn for routine tests and to check how the
transplant has taken.

- Blood (about 2 teaspoons each time) will be drawn before and after your dose of study
drug to check the immune system.

On Days 3 and 5 of Cycle 1, blood (about 2 teaspoons) will be drawn to check the immune
system.

About 5 days before Day 1 of Cycles 2-6:

- You will have a physical exam.

- Blood (about 2 tablespoons) will be drawn for routine tests and to check the immune
system.

If your doctor thinks it is needed, you may have a skin biopsy or endoscopy to check for GVHD
and/or graft failure. You will sign a separate consent form that explains the procedures and
risks.

Length of Study:

You will be taken off study 1 year after the transplant. You will no longer be able to take
the study drug if the disease gets worse, if intolerable side effects occur, if you develop
an infection (such as cytomegalovirus [CMV] that does not respond to treatment), or if you
are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Follow-Up Visits:

About 1, 3, 6, and 12 months after the transplant, you will have follow-up visits as part of
your standard of care after your transplant. At these visits:

- You will have a physical exam

- Blood (about 4 tablespoons) will be drawn for routine tests, to learn how the transplant
has taken, and to check the status of the disease.

- You will have a computed tomography (CT) scan to check the status of the disease.

- You will have a bone marrow biopsy and aspiration to check the status of the disease and
for cytogenetic testing. To collect a bone marrow biopsy/aspirate, an area of the hip or
other site is numbed with anesthetic, and a small amount of bone marrow and bone is
withdrawn through a large needle. Cytogenetic testing looks at how genetic changes to
cells may affect how the disease may react to the study drug.

This is an investigational study. Brentuximab vedotin is FDA approved and commercially
available for the treatment of Hodgkin lymphoma and ALCL. It is investigational to give
brentuximab vedotin at an earlier time after a transplant.

Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Patients with CD30 positive Hodgkin Lymphoma (HL) or anaplastic large cell lymphoma
(ALCL) that have undergone allogeneic or haploidentical SCT in the past 60 days
(matched related or matched unrelated donors only).

2. Age 18 to 65 years.

3. Performance status: Zubrod 0-1 or Karnofsky 80-100.

4. Serum creatinine < 1.5 mg/dL or creatinine clearance greater than or equal to 40
cc/min as defined by MDRD method from National Kidney Disease Education Program
(NKDEP).

5. Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome).

6. SGPT < 200 IU/L unless related to patient's malignancy.

7. Evidence of neutrophil and platelet engraftment, defined as platelet count equal or
greater than 50,000 mm3 independent of platelet transfusion and ANC equal or greater
to 1000 without growth factor support for at least 5 days.

8. Patients with previous exposure to brentuximab pre-transplant are eligible for the
study.

Exclusion Criteria:

1. Pregnancy or breast-feeding (women of childbearing potential, any female who has
experienced menarche and who has not undergone surgical sterilization or is
post-menopausal with a positive serum pregnancy test.

2. Presence of steroid-refractory acute graft-versus-host disease (GVHD).

3. Patients that underwent allogeneic transplantation as a treatment of graft failure.

4. Dual refractory CMV reactivation to foscarnet and ganciclovir or evidence of CMV
disease.