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Safety and Efficacy of Campath in Nonmyeloablative Transplantation

70 Years
Not Enrolling
Lymphoma, Leukemia

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Trial Information

Safety and Efficacy of Campath in Nonmyeloablative Transplantation

Alemtuzumab is a drug that can specifically attack some types of leukemia and lymphoma
cells. In addition, it suppresses the patients' immune system, therefore helps preventing
the rejection of donor marrow or stem cells.

Before treatment starts, patients will have a physical exam, including blood tests (between
100 - 120 cc) and urine tests. Women who are able to have children will have a pregnancy
test. Bone marrow samples will be taken. Patients will have a chest x-ray, CT scans and EKG,
and tests of lung function.

Blood tests (between 100 - 120 cc) marrow sampling, and x-rays will be done as needed to
track the effects of the transplant. For bone marrow sampling, a large needle is placed into
the numbed hipbone. The bone marrow is then withdrawn through the needle. Patients will have
transfusions of blood and platelets as needed. Blood tests (between 100 - 120 cc) will be
done daily while patients are in the hospital.

Alemtuzumab will be injected into the patient's vein. This will be done 3 days in a row
(days 1 to 3). The drugs diphenhydramine (Benadryl) and acetaminophen (Tylenol) will be
given in to prevent or ease side effects.

Patients will also receive fludarabine and cyclophosphamide daily for 3 days. They will be
given on the same days as alemtuzumab. Rituximab will be given (to some patients only, based
on the subtypes of lymphomas) eight days before the transplant and then weekly for a total
of 4 doses.

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. 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 the neutrophil counts recover in the blood.

A "boost" of donor cells (lymphocytes) will be given at 3 months after transplant if the
disease is getting worse or if DNA tests from the blood shows that not all lymphocytes in
the blood are from the donor. These cells will be given through the vein, without
chemotherapy, in the clinic.

Treatment will be given in the hospital at M. D. Anderson. Patients will need to stay in the
hospital for about 3 to 4 weeks. Patients will be taken off study if their disease

Patients must stay in the Houston area for about 100 days after the transplant. After that,
patients will need to return to Houston from time to time for blood tests, urine tests, and
other exams.

This is an investigational study. The FDA has approved the drugs used in this study. Their
use together in this study is investigational. About 100 patients will take part in this
study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Up to 70 years of age (physiological).

2. Any histological subtype of lymphoid malignancies (those with CD20 negative disease
will not receive Rituximab).

3. Patients in relapse with a partial remission or stable disease.

4. Patients who failed a prior autologous transplant are also eligible.

5. Patients must have a matched unrelated donor and no human leukocyte antigen (HLA)
identical sibling is available. Point scale (PS)<2.

6. Patients are included even if they were previously exposed to Campath or Rituximab.

Exclusion Criteria:

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

2. Less than 4 weeks since prior chemotherapy counted from 1st day of treatment regimen.

3. Pregnancy or lactation.

4. HIV or HTLV-I positively.

5. Serum creatinine >1.6mg/dl or serum bilirubin >1.5mg/dl unless due to tumor.

6. Pulmonary function tests (PFTs) -OLCO<50%, cardiac EF <50% of predicted levels.

7. Patient with severe concomitant medical or psychiatric illness.

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:

Number of Participants Surviving 100 days post-transplant

Outcome Time Frame:

30 Day Engraftment (Baseline) to 100 Days post-transplant

Safety Issue:


Principal Investigator

Issa F. Khouri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2001

Completion Date:

September 2010

Related Keywords:

  • Lymphoma
  • Leukemia
  • Lymphoma
  • Leukemia
  • Campath-1 H
  • Campath
  • Alemtuzumab
  • Fludarabine
  • Fludarabine Phosphate
  • Fludara
  • Cyclophosphamide
  • Cytoxan
  • Neosar
  • Rituxan
  • Rituximab
  • Leukemia
  • Lymphoma



U.T.M.D. Anderson Cancer Center Houston, Texas  77030