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Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52


Phase 2
N/A
70 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52


Campath is a drug that can specifically attack some types of T-cell lymphoma cells.

Before the study begins, you will have a physical exam, including blood (about 2
tablespoons) and urine tests. Women who are able to have children must have a negative
blood pregnancy test. Bone marrow samples will be taken. To collect a bone marrow sample,
an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone
marrow is withdrawn through a large needle. Patients will have a chest x-ray, an EKG (test
to measure the electrical activity of the heart), and tests of lung function. Patients
whose disease affects the stomach or intestines may have biopsies of these areas.

Treatment will be given in the hospital at M. D. Anderson. You will need to stay in the
hospital for about 3 to 4 weeks.

A central venous catheter (plastic tube) will be placed into the large chest vein. The
catheter will be left in place throughout treatment. In order to collect stem cells, G-CSF
and GM-CSF will be injected under the skin. This will be done twice a day until the
collection of stem cells is complete. You will receive Campath -1H through the catheter on
Days 1, 2, 3, and 10 of chemotherapy treatment.

The stem cells will be collected from you starting about 10 to 14 days after chemotherapy is
given. The collection process is called apheresis. Blood is removed from the your body and
the stem cells are frozen for storage. Stem cell collection takes about 3 hours. Between 3
and 5 sessions may be needed to collect enough stem cells. Sessions will be done once a
day.

After stem cells are collected, you will receive high dose Carmustine over 1 hour on Day 1.
You will receive cytarabine and etoposide twice a day on Days 2 through 5 and melphalan on
Day 6.

One day after finishing the chemotherapy, the stem cells that were collected earlier will be
infused back into you over about 30 minutes. G-CSF and GM-CSF will be injected until your
white blood cell counts returns to normal.

Blood tests (1-2 tablespoons), urine tests, bone marrow sampling, and x-rays will be done as
needed to track the effects of the transplant. You will have transfusions of blood and
platelets as needed. Blood tests (1-2 tablespoons) will be done daily while you are in the
hospital.

You might have to stay in the Houston area for 2 to 4 weeks after the transplant. After
that, you will need to return to Houston every 3 months for the first year, then every 6
months for 5 years. Three months after the transplant, bone marrow exams and other tests
will be done. If you show evidence of disease, you will receive another cycle of Campath
-1H three times a week for 4-12 weeks. Patients will be taken off study if the disease
gets worse or intolerable side effects occur.

This is an investigational study. The FDA has approved the drugs used in this study. Their
use together in this study is investigational. About 30 patients will take part in this
study. All will be enrolled at M. D. Anderson.

Nonmyeloablative Allogeneic Transplantation with Campath-1H for T-cell Lymphoma:

Campath is a drug that can specifically attack some types of T-cell lymphoma cells. In
addition, it weakens the immune system, therefore 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.

Before the study begins, you will have a physical exam, including blood (about 1-2
tablespoons) and urine tests. Women who are able to have children must have a negative
blood pregnancy test. Bone marrow samples will be taken. To collect a bone marrow sample,
an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone
marrow is withdrawn through a large needle. You will have a chest x-ray, CT scans, an EKG
(test to measure the electrical activity of the heart), and tests of lung function.

Blood tests (1-2 tablespoons), urine tests, bone marrow sampling, and x-rays will be done as
needed to track the effects of the transplant. Patients will have transfusions of blood and
platelets as needed. Blood tests (1-2 tablespoons) will be done daily while you are in the
hospital.

Campath-1 H will be injected into your vein. This will be done 3 days in a row (Days 1 to
3). The drugs diphenhydramine (Benadryl), acetaminophen (Tylenol) and hydrocortisone will be
given in to decrease the risk of or ease side effects.

You will also receive fludarabine and cyclophosphamide daily for 3 days. They will be given
starting day of Campath -1H.

All of the chemotherapy 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. 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 and GM-CSF, growth factors that
promote the production of blood cells, will be injected under the skin once a day until the
neutrophil counts recover in the blood.

Tacrolimus will be infused through the vein, starting 2 days before transplant to decrease
the risk of graft-versus-host disease. It will be changed to pills after you are discharged
from the hospital. For the same purpose, methotrexate will also be given through the vein
on Days 1, 3, 6 (and Day 11 if unrelated donor).

Treatment will be given in the hospital at UTMDACC. You will need to stay in the hospital
for about 3 to 4 weeks.

You must stay in the Houston area for about 100 days after the transplant. After that, you
will need to return to Houston every three months for the first year, then every 6 months
for 5 years for blood tests (1-2 tablespoons), urine tests, and CT scans. Bone marrow
aspirations and biopsies will also be performed. Patients will be taken off study if the
intolerable side effects occur.

This is an investigational study. The FDA has approved the drugs used in this study. Their
use together in this study is investigational. About 30 patients will take part in this
study. All will be enrolled at UTMDACC.


Inclusion Criteria:



- Patients must be less then 70 years old.

- Patients must have chemosensitive disease, having undergone at least partial
remission with less then 10% marrow involvement by gross pathologic examination if
autologous transplantation is considered.

- Newly diagnosed patients are eligible for autologous transplant. Patients in
relapse would receive a non-myeloablative transplant if a sibling donor is available.
Otherwise, patients would undergo autologous transplant if International Prognostic
Index (IPI) is 0-1, or unrelated transplant if IPI is > 1.

Exclusion Criteria:

- Criteria for exclusion are Human immunodeficiency virus (HIV) or Human T-lymphotropic
virus (HTLV) seropositivity, pregnancy, cardiac ejection fraction by echo-cardiogram
less than 40%, active central nervous system involvement, serum creatinine greater
than 1.6 mg/dl or serum bilirubin greater than 1.5 mg/dl unless due to tumor,
Absolute neutrophil count (ANC) less than 1,000/mm3 and platelets less than
100,000/mm3 unless due to tumor, performance status (ECOG scale) greater than 2,
pulmonary function test- diffusing capacity of the Lung for Carbon Monoxide (DLCO)
less than 40% of predicted, and severe concomitant medical or psychiatric illnesses.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Participant Progression Free Survival at 2 Years

Outcome Description:

Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Issa F. Khouri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID02-645

NCT ID:

NCT00505921

Start Date:

March 2003

Completion Date:

November 2009

Related Keywords:

  • Lymphoma
  • T-Cell Lymphoma
  • Lymphoma
  • Campath-1H
  • Allogenic Transplantation
  • Stem Cell Transplant
  • Alemtuzumab
  • Lymphoma
  • Lymphoma, T-Cell

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030