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Campath-1H Snd Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies

15 Years
60 Years
Not Enrolling
Leukemia, Lymphocytic, Chronic, Leukemia, Lymphocytic, Acute, Lymphoma, Low-Grade, Lymphoma, T-Cell, Lymphoma, B-Cell

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Trial Information

Campath-1H Snd Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies

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.

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 5 days in a row (Days 1 to 5). 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 Carmustine over one hour on the first day. From the second to the
fifth day, you will receive cytarabine and etoposide twice a day. On the six day, you will
receive melphalan once. 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 during the first day of chemotherapy then once a week
for a total of 4 doses.

When chemotherapy is finished, 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 need to stay in the hospital about 3 to 4 weeks. You will be taken off study if
their disease gets worse or intolerable side effects occur. You must stay in the Houston
area for about 100 days after the transplant. After that, you will be asked to return to
Houston every 6 months for the next 3-5 years for scans (CT, gallium, or PET scans), and
bone marrow aspirations over the next 3-5 years.

This is an investigational study. The FDA has approved the drugs used in this study. Their
use together in this study is investigational. About 142 patients will take part in this
study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. 15-65 years old

2. B or T-cell lymphoid disease, not eligible for non-myeloablative transplantation.

3. Patients in relapse after failing conventional chemotherapy.

4. Patients with HLA-identical or one-antigen mismatched sibling, or a matched unrelated

5. Performance status
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.

3. Pregnancy or lactation.

4. HIV or HTLV-I positivity.

5. Serum creatinine >1.6 mg/dl or serum bilirubin >0.2 mg/dl unless due to tumor, SGPT
>/= 2 x NI

6. PFT-DCLO<50%, cardiac EF <50% of predicted levels.

Type of Study:


Study Design:

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

Outcome Measure:

CAMPATH 2-year event-free survival rate

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Issa F. Khouri, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2001

Completion Date:

May 2006

Related Keywords:

  • Leukemia, Lymphocytic, Chronic
  • Leukemia, Lymphocytic, Acute
  • Lymphoma, Low-Grade
  • Lymphoma, T-Cell
  • Lymphoma, B-Cell
  • Lymphoid Malignancies
  • Chronic Lymphocytic Leukemia
  • Acute Lymphoblastic Leukemia
  • Low grade Lymphoma
  • B and T cell Lymphoma of the intermediate and high grade
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell



UT MD Anderson Cancer Center Houston, Texas  77030