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Total Lymphoid Irradiation, Thymoglobulin, and Rituximab for Allogeneic Transplantation in Lymphoid Malignancies

70 Years
Not Enrolling
Lymphoma, Leukemia

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Trial Information

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
gets worse.

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.

Inclusion Criteria:

- Age up to 70 years.

- Patients with lymphoid malignancies (primary refractory or recurrent) beyond first
remission or unresponsive to therapy and not eligible for protocols of higher
priority. Patients should have had at least a partial remission or have stable
disease with prior chemotherapy. Patients with bulky disease (greatest dimension > 5
cm by radiographic or clinical examination are not eligible).

- Adequate renal function, as defined by serum creatinine <1.8 mg/dL.

- Adequate hepatic function, as defined by SGPT <3 times upper limit of normal; serum
bilirubin and alkaline phosphatase <3 times upper limit of normal.

- Adequate pulmonary function with Forced expiratory volume in one second (FEV1),
forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) >35% of
expected corrected for hemoglobin. Exceptions may be allowed for patients with
pulmonary involvement after discussing with Principal Investigator.

- Adequate cardiac function with left ventricular ejection fraction >35%. No
uncontrolled arrhythmias or symptomatic cardiac disease.

- Zubrod performance status <2

- Patients must have an human leukocyte antigens (HLA) matched, or one A, B, C, DR, or
DQ mismatched related or unrelated donor (by high resolution typing). Donor must be
willing to donate peripheral blood progenitor cells.

- Patient should be willing to participate in the study by providing written consent.

- Negative beta human chorionic gonadotrophin (hCG) test in a woman of child bearing
potential (defined as not post menopausal for 12 months or no previous surgical

Exclusion Criteria:

- Patients with active central nervous system (CNS) disease.

- Evidence of acute or chronic active hepatitis or cirrhosis.

- Uncontrolled infection, including Hepatitis B, C, Human immunodeficiency virus (HIV)
or human T-cell lymphotropic virus type 1 (HTLV-1) infection.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Composite Success Rate

Outcome Description:

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.

Outcome Time Frame:

Baseline to Day 100, assessment at Day 100

Safety Issue:


Principal Investigator

Chitra M. Hosing, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2006

Completion Date:

May 2009

Related Keywords:

  • Lymphoma
  • Leukemia
  • Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Hodgkin's Lymphoma
  • Lymphoma
  • Leukemia
  • Mycophenolate Mofetil
  • Tacrolimus
  • Thymoglobulin
  • Total Lymphoid Irradiation
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Hematologic Neoplasms



U.T.M.D. Anderson Cancer CenterHouston, Texas  77030