Total Lymphoid Irradiation, Thymoglobulin, and Rituximab for Allogeneic Transplantation in Lymphoid Malignancies
The combination of drugs used for this study will help to weaken your immune system, which
may help to allow the donor's blood stem cells to engraft (grow) in your body.
Anti-thymocyte globulin (also called ATG or thymoglobulin) is designed to help reduce the
risk of transplant rejection and to help prevent graft versus host disease.
Rituximab is designed to attach to lymphoma cells, which may cause them to die.
If you are found to be eligible to take part in this study, you will be admitted to the
hospital 12 days before the blood stem cell transplant (BSCT), in order to start the
pre-transplant treatments and testing. You will have blood (about 1 tablespoon) drawn for
routine tests every day while you are in the hospital (before and after the transplant).
After the transplant, this blood will be used to check the status of the transplant and
watch for any side effects.
You will receive radiation therapy (total lymphoid irradiation) for a total of 10 days
before the planned transplant. Radiation therapy will not be given on the weekends. The
last radiation treatment will be on the morning of the day you receive your stem cell
For a total of 5 days after admission to the hospital, you will also receive ATG. ATG will
be given through a catheter (plastic tube) that is placed into the large chest vein. The
catheter (called a central venous catheter) will stay in place throughout treatment.
You will receive certain drugs as premedication to try to prevent an allergic reaction to
the ATG. These may include drugs like acetaminophen (Tylenol), diphenhydramine (Benadryl),
and/or steroids which may include solumedrol or prednisone. Tylenol is given by mouth, and
Benadryl and steroids are given either by vein (over 10-15 minutes) or by mouth.
The combination of ATG and radiation will weaken your immune system. A weakened immune
system may help to allow your body to "accept" donor cells, and it may decrease the chance
of your body rejecting the cells.
If your diagnostic biopsy showed that a certain protein was found on your tumor cells, you
may also receive rituximab therapy. If you are eligible for rituximab treatment, you will
receive the drug once a week for 4 weeks. You will receive rituximab through the central
venous catheter or through a vein over 6-8 hours. The first dose will be given on an
outpatient basis at 13 days before the stem cell transplant. The next 3 doses may be given
in the hospital or on an outpatient basis. You will receive rituximab 6 days before the
transplant, and then 1 and 8 days after the transplant. Tylenol and steroids will be given
before the rituximab to try to prevent an allergic reaction.
You will be given tacrolimus to try to prevent graft versus host disease (when the donor's
immune cells react against the recipient's body, attacking the recipient's cells and
tissues). You will receive tacrolimus either through the central venous catheter (over 24
hours each time) or by mouth starting 3 days before the stem cell transplant. You will
continue receiving tacrolimus as long as your doctor feels it is necessary, which could be
anywhere from about 3 months to several years. This will depend on factors such as whether
or not you have graft versus host disease, how many donor cells are in your blood, and the
status of your disease.
Cellcept (MMF) will also be given to try to prevent graft versus host disease, starting 1
day after the transplant and continuing through Days 28-42 after the transplant. The MMF
will be given twice a day through the central venous catheter over 2 hours, or by mouth.
After the pre-transplant treatments and testing are finished, you will have the blood stem
cell transplant. Blood stem cells from a donor will be infused over about 1 hour through
your central venous catheter. This can be done while you are in the hospital or on an
outpatient basis at M. D. Anderson. Steroids and Benadryl will be given through the
catheter before the stem cell transplant to try to prevent an allergic reaction. The
catheter will be removed once you no longer need to be given fluids, blood products, and
other treatments through the catheter for graft versus host disease. This may take anywhere
from 3 months after the transplant to several years.
You will have additional blood (about 2 tablespoons) drawn, bone marrow aspirations and
biopsies, chest CT scans, and/or chest x-rays performed as needed to check the effects of
the transplant. You will have transfusions of blood and platelets as needed, and you will
have to sign a separate consent document for these transfusions.
Blood (about 1 tablespoon each time) will also be drawn at least 2-3 times a week for at
least 100 days after the transplant, or longer if the study doctor feels it is necessary.
Treatment will be given in the hospital or an outpatient basis at M. D. Anderson. You may
need to stay in the hospital for 3-4 weeks. You will be taken off the study if your disease
This is an investigational study. The FDA has approved the drugs used in this study. Their
use together in this study is investigational. Up to 40 patients will take part in this
study. All will be enrolled at M. D. Anderson Cancer Center.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Composite Success Rate
Defined as the proportions of the patients who are alive at day 100, are without Grade 3-4 Graft Graft-versus-host disease (GVHD), without Grade 4 toxicity (unrelated to infection) and have engrafted. Toxicity grades according to Common Toxicity Criteria (CTC) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Baseline to Day 100, assessment at Day 100
Chitra M. Hosing, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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