Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease

Central Venous Catheter:

If you choose to take part in this study, the chemotherapy, some of the other drugs in this
study, and the stem cell transplant and immune cells will be given by vein through your
central venous catheter (CVC). A CVC is a sterile flexible tube and needle that will be
placed into a large vein while you are under local anesthesia. Blood samples will also be
drawn through your CVC. The CVC will remain in your body during treatment. Your doctor will
explain this procedure to you in more detail, and you will be required to sign a separate
consent form.

Study Drug Administration:

The days before you receive your stem cells are called minus days, such as Day -2, Day -1.
The day you receive the stem cells is called Day 0. The days after you receive the stem cells
are called plus days, such as Day +1, Day +2.

On Day -7, you will receive gemcitabine by vein over about 40-180 minutes.

On Day -6, you will be admitted to the hospital and given fluids by vein to hydrate you.

On Days -5 and -4, you will receive fludarabine by vein over about 30 minutes.

On Days -4 and -3, you will receive thymoglobulin, if you are receiving a transplant from a
matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative,
but not a full match), you will also receive antithymocyte globulin (ATG)

On Days -3 and -2, you will receive fludarabine by vein over about 30 minutes and melphalan
over about 30 minutes.

On Day -1, you will "rest" (not receive chemotherapy).

On Day 0, you will receive the donor's stem cells and immune cells by vein. The infusion will
last anywhere from about 30 minutes to several hours. You may be given other standard drugs
to help lower the risk of side effects. You may ask the study staff for more information
about how the drugs are given and their risks. All participants are expected to need blood
transfusions as part of this treatment.

Beginning on Day -2, tacrolimus will be given by vein over 24 hours to help lower the risk of
graft-versus-host disease (GVHD). This will be changed to pills once you can tolerate
swallowing pills. If no active cancer is detected and there is no GVHD, you will then swallow
1 or more tacrolimus pills a day for only about 3-4 months, instead of the usual period of 6
months. This is done to boost the donor immune system against the cancer.

Starting 1 week after the transplant (Day +7), you will receive filgrastim (G-CSF) as an
injection under the skin 1 time each day until your blood cell levels return to normal.
Filgrastim is designed to make white blood cells grow, which may help to fight infections.

On Days +1, +3, +6, and +11, you will receive methotrexate by vein to decrease the risk of
GVHD.

If you have persistent but stable (not "growing") disease after transplant, you will have
your immunosuppressive medications (tacrolimus, corticosteroids) stopped even before 4
months. If there is no response, you will receive an infusion of additional cells from your
donor.

Study Visits:

About 30 days before receiving the stem cells, you will have computed tomography (CT) and/or
positron emission tomography (PET) scans to check the status of the disease.

About every day until discharge, and then at least weekly:

- You will have a physical exam.

- Blood (about 4 tablespoons) will be drawn for routine tests.

Follow-Up Visits:

About 100 days after the transplant:

- You will have a physical exam.

- Blood (about 4 tablespoons) will be drawn for routine tests. Part of the blood sample
may be used for chimerism analysis (determination of donor or recipient cells), if
needed.

- At any point that your doctor thinks they are needed, you will have a bone marrow
aspiration, chest x-rays, and CT and/or PET scans to check the status of the disease. To
collect a bone marrow aspirate, an area of the hip or other site is numbed with
anesthetic, and a small amount of bone marrow is withdrawn through a large needle.

About 6 months, 1 year, then annually after the transplant:

- You will have a physical exam.

- Blood (about 4 tablespoons) will be drawn for routine tests. Part of the blood sample
may be used for chimerism analysis (determination of donor or recipient cells), if
needed. Part of the blood will be used to check your thyroid function once a year.

- At any point that your doctor thinks they are needed, you will have a bone marrow
aspiration, chest x-rays, and CT and/or PET scans to check the status of the disease.

- You may have lung function tests, if your doctor thinks it is needed.

- About 6 months after the transplant, you may have a biopsy, if your doctor thinks it is
needed.

- About once a year, you will have an eye exam.

The above tests/procedures may be repeated more often, if you doctor thinks it is needed.

The study staff will also stay in contact with your local doctor to find out if the disease
comes back and to check how you are doing.

Length of Treatment:

You will be on study for about 3 years. After 1 year, there is no study specific testing you
will be required to complete. Your transplant doctor will perform routine standard of care
follow-up that all patients receiving allogeneic stem cell transplantation receive.

You may be removed from the study early if the doctor thinks it is in your best interest, if
the disease gets worse or comes back, if intolerable side effects occur, if you have graft
failure (the transplanted cells do not grow), or if you are unable to follow study
directions.

If for any reason you want to leave the study early, you must talk to the study doctor. It
may be life-threatening to leave the study after you have started to receive the study drugs
but before you receive the stem cell transplant because your blood cell counts will be
dangerously low.

This is an investigational study. All of the drugs used in this study are FDA-approved and
commercially available. Up to 70 patients will take part in this study. All will be enrolled
at MD Anderson.

Inclusion Criteria:

1. Patients < 65 years of age with histologically confirmed refractory or relapsed
Hodgkin's disease (including patients who fail or relapse after autologous SCT). This
upper age limit will apply to transplants from both matched related and unrelated
donors.

2. Patients should have any of the following disease status: a. responsive or stable
disease on salvage chemotherapy or radiation therapy. b. untreated, smoldering (i.e.
not rapidly progressive) relapses.

3. Patients must have a serum bilirubin equal to or hyperbilirubinemia related to Gilbert's disease allowed), serum transaminase (ALT)
equal to or mg/dl (provided they also have a glomerular filtration rate of at least 55 ml/min), no
symptomatic cardiac or pulmonary disease and a performance status equal to or Left ventricular ejection fraction >/= 40%, forced expiratory volume at one second
(FEV1), forced vital capacity (FVC) and corrected diffusing capacity of lung for
carbon monoxide (DLCO) >/= 50% predicted.

4. Patients must have an HLA-compatible related or unrelated donor (one-antigen
mismatched related donors are acceptable) willing to donate marrow or
rhG-CSF-mobilized peripheral blood stem cells. In the event of transplants from
matched unrelated donors, a high-resolution allele match for HLA-A, -B, -C, -DRB1 ("8
of 8 match") is required.

5. Women of childbearing potential must have a negative serum pregnancy test within two
weeks of study entry and should be advised to avoid becoming pregnant. Men should be
advised to not father a child while on treatment. Both women of childbearing potential
and men must agree to practice effective methods of contraception.

6. Patients must be capable and willing to sign informed consent.

Exclusion Criteria:

1. Patients with documented disease progression on salvage chemotherapy.

2. Nursing or pregnant females. Should a woman become pregnant or suspect she is pregnant
while participating in the study, she should inform her treating physician
immediately.

3. Severe concomitant medical or psychiatric illness.

4. Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease.

5. Chronic active hepatitis or cirrhosis.

6. Active or uncontrolled infection.

7. Radiation therapy involving chest (axilla excluded), mediastinum, or abdomen (i.e.,
small or large bowel) completed within 10 weeks of transplant admission. Radiation
therapy shortly before the start of the preparative regimen is allowed.

8. Prior or concurrent malignancies (including myelodysplasia) except resected basal cell
carcinoma or treated carcinoma in-situ. Cancer treated with curative intent < 5 years
previously will not be allowed unless approved by the Protocol Chair. Cancer treated
with curative intent > 5 years previously will be allowed.