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Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen for Advanced/Recurrent Mantle Cell Lymphoma

70 Years
Not Enrolling

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Trial Information

Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen for Advanced/Recurrent Mantle Cell Lymphoma


If you are found to be eligible to take part in this study, you will be admitted to the
hospital to receive treatment. Two (2) chemotherapy drugs, fludarabine and
cyclophosphamide, will be given each day for 3 days. The drugs will be given one at a time
in a vein. Each treatment will take about 30 minutes. Fludarabine will be given first, and
cyclophosphamide will be given 4 hours later. You will receive rituximab once a week for 4
weeks by vein over 4-8 hours. The first dose will starts one week before starting the

Two days after finishing chemotherapy, you will receive a transplant of stem cells from a
sibling. The stem cells will be infused into your vein. Seven days later, you will begin
to receive a drug called granulocyte colony-stimulating factor (G-CSF). G-CSF helps the new
stem cells do their normal work in the body;making new blood cells. You will receive G-CSF
each day until your blood cell counts begin to recover to a certain level.

Sometimes the donor cells cause inflammation of the skin, liver and gut, and a reaction
called graft-versus-host disease occurs. The drugs tacrolimus and methotrexate will be
given to help decrease the risk of this. These drugs are also given through a vein before
and after transplant . Tacrolimus will be infused two days before transplant and will
continue to be given daily as a continuous infusion. Methotrexate will be given through the
vein as a short infusion on Days 1, 3, and 6 after the transplant. Tacrolimus also comes in
pill form, and you may switch to the pills when ready.

During your hospitalization, you will be examined daily, and blood (about 1 tablespoon)
samples will be taken daily to evaluate your blood count levels, the function of your liver
and kidneys, as well as electrolytes. This blood will also be used to measure tacrolimus
levels and to look for any infections. You might be given blood transfusions if blood cell
counts remain low.


Alemtuzumab is a drug that is designed to specifically attack some types of leukemia and
lymphoma cells. In addition, it weakens the immune system, helping to prevent the rejection
of donor marrow or stem cells.

TBI is designed to damage the DNA (the genetic material of cells) of cancer cells, which may
kill the cancer cells.

Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may
slow or stop their growth and spread throughout the body. This may cause the cancer cells
to die.

Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may
increase the likelihood of the cells dying.

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 for treatment. Alemtuzumab will be injected into your vein over a period of 4
hours. This will be done 3 days in a row (Days 1 to 3). Drugs diphenhydramine (Benadryl),
solumedrol and acetaminophen (Tylenol) will be given in to decrease the risk of or ease side
effects before each dose of the alemtuzumab.

You will also receive fludarabine and cyclophosphamide once a day for 3 days. They will be
given on the same days as alemtuzumab. Both drugs will be given through a catheter (plastic
tube) that extends into the large chest vein. The catheter will be left in place throughout
treatment on this study. Some participants, depending on their type of disease, will also
receive rituximab. Rituximab will be given 8 days before the transplant and then once a
week for a total of 4 doses.

After completion of chemotherapy, you will receive TBI, and later on the same day, blood
stem cells from a donor will be given through the catheter. G-CSF, a growth factor that
promotes the production of blood cells, will be injected under the skin once a day until
your blood cell counts recover to a certain level.

Blood tests (about 2 tablespoons each) , urine tests, bone marrow aspirations, and x-rays
will be done as needed to track the effects of the transplant. The blood tests will be drawn
daily while in the hospital and then at least twice weekly as an outpatient for the first
100 days. The CT scans and bone marrow studies will be done at 1, 3, 6, and 12 months and
then every 6 months for at least 3 years after transplant. You may also have transfusions
of blood and platelets as needed.


You will receive treatment as an outpatient. You will receive rituximab over 4 - 8 hours
through a vein once a week for 4 weeks. You will also get a boost of cells from the same
donor from whom you received the original transplant. These additional cells will be
infused through the vein (over 30 - 60 minutes) between the second and the third dose of
rituximab. The infusion may have to be done later if cells were not available as scheduled.

Sometimes the donor cells cause inflammation of the skin, liver and gut, and a reaction
called graft-versus-host disease occurs. If this happens, the drug tacrolimus and
methotrexate will be given to help control this reaction. These medications are usually
given by pills on a daily basis.

A boost with a higher number of cells may be infused once a month for 3 months if there is
no graft-versus-host disease and if disease remains.

During treatment, you will be examined as needed, and blood samples (1 tablespoon once or
twice a week) will be taken for routine tests. You may need to receive blood transfusions
during this study if your blood cell counts remain low.


About 40 patients will take part in this study, and all will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Patients can be as old as 70 years.

2. They must have a diagnosis of MCL, either (1) Recurrent, (2) Newly diagnosed (after
cytoreduction with conventional chemotherapy) but with high-risk features (blastic or
blastoid features, leukemic phase, or elevated B^2 microglobulin (> 3).

3. Patients that have received prior conventional chemotherapy but have not achieved
complete response (CR).

4. Disease must be chemosensitive, (ie, patients must not have had a partial response to
prior therapy).

5. Patients whose disease failed to respond to a previous autologous transplantation may
also be eligible.

6. Patients must have a matched or 1 antigen mismatched sibling or unrelated donor.

7. Point Scale (PS)
8. Inclusion criteria for Immunomodulation Post transplantation: Patients can be as old
as 70 years. Patients must have a diagnosis of MCL or CLL with one of the following
characteristics: 1. Patients who develop disease progression or do not experience a
CR within 3 months post-allogeneic transplantation 2. Patients with a weak chimerism
(any mixed chimerism of donor T cells in patients receiving Campath by day 90, and
less than 20% for patients not receiving Campath) or a drop of 20% or more with an
amount of donor cells present in the blood < 50% by PCR .

9. Continued from Inclusion # 8: Patients must have the same donor of the original
transplant willing to donate lymphocytes. 4. PS
Exclusion Criteria:

1. Past history of anaphylaxis following exposure to rat- or mouse-derived CDR-grafted
humanized monoclonal antibodies.

2. Less than 4 weeks since prior chemotherapy counted from first day of treatment

3. Pregnancy or lactation.

4. HIV or HTLV-I positivity.

5. Serum creatinine concentration > 1.6 mg/dl or serum bilirubin > 2.0 mg/dl unless due
to tumor

6. pulmonary function test - carbon monoxide diffusing capacity < 40%

7. cardiac ejection fraction < 40% of predicted levels (by multiple-gated acquisition or

8. Severe concomitant medical or psychiatric illness.

Type of Study:


Study Design:

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

Outcome Measure:

Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)

Outcome Description:

Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma.

Outcome Time Frame:

100 days post transplant

Safety Issue:


Principal Investigator

Issa F. Khouri, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2005

Completion Date:

September 2010

Related Keywords:

  • Lymphoma
  • Mantle Cell Lymphoma
  • Lymphoma
  • Allogeneic Stem Cell Transplant
  • Rituximab
  • Cyclophosphamide
  • Neosar
  • Cytoxan
  • Fludarabine
  • Fludara
  • Fludarabine phosphate
  • Rituxan
  • Alemtuzumab
  • Campath
  • Total Body Irradiation
  • TBI
  • Lymphoma
  • Lymphoma, Mantle-Cell



UT MD Anderson Cancer Center Houston, Texas  77030