Stem Cell Transplant Therapy With Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome
Status:
Completed
Trial end date:
2019-01-24
Target enrollment:
Participant gender:
Summary
This study will investigate the safety and effectiveness of a modified donor stem cell
transplantation procedure for treating advanced mycosis fungoides (MF), a lymphoma primarily
affecting the skin, and Sezary syndrome (SS), a leukemic form of the disease. Donated stem
cells (cells produced by the bone marrow that mature into the different blood components
white cells, red cells and platelets) can cure patients with certain leukemias and lymphomas
and multiple myeloma. These cells generate a completely new, functioning bone marrow. In
addition, immune cells from the donor grow and generate a new immune system to help fight
infections. The new immune cells also attack any residual tumor cells left in the body after
intensive chemotherapy. However, stem cell transplantation carries a significant risk of
death, because it requires completely suppressing the immune system with high-dose
chemotherapy and radiation. In addition, lymphocytes from the donor may cause what is called
graft vs. host disease (GvHD), in which these cells see the patient s cells as foreign and
mount an immune response to destroy them. To try to reduce these risks, patients in this
study will be given low-dose chemotherapy and no radiation, a regimen that is easier for the
body to tolerate and involves a shorter period of complete immune suppression. In addition, a
monoclonal antibody called Campath-1H will be given to target lymphocytes, including those
that have become cancerous.
Patients with advanced MF or SS who are between 18 and 70 years of age and have a matched
family donor 18 years of age or older may be eligible for this study. Candidates will have a
medical history, physical examination and blood tests, lung and heart function tests, X-rays
of the chest, eye examination, and bone marrow sampling (withdrawal through a needle of about
a tablespoon of marrow from the hip bone), and small skin biopsy (surgical removal of a piece
of tissue for microscopic examination) or needle biopsy of the tumor.
Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF
will be injected under the skin for several days to push stem cells out of the bone marrow
into the bloodstream. Then, the stem cells will be collected by apheresis. In this procedure
the blood is drawn through a needle placed in one arm and pumped into a machine where the
required cells are separated out and removed. The rest of the blood is returned through a
needle in the other arm.
Before the transplant, a central venous line (large plastic tube) is placed into a major
vein. This tube can stay in the body and be used the entire treatment period to deliver the
donated stem cells, give medications, transfuse blood, if needed, and withdraw blood samples.
Several days before the transplant procedure, patients will start a conditioning regimen of
low-dose chemotherapy with Campath 1H, fludarabine, and, if necessary, cyclophosphamide. When
the conditioning therapy is completed, the stem cells will be infused over a period of up to
4 hours. To help prevent rejection of donor cells and GvHD, cyclosporine and mycophenolate
mofetil will be given by mouth or by vein for about 3 months starting 4 days before the
transplantation.
The anticipated hospital stay is 3 to 4 days, when the first 3 doses of Campath will be
monitored for drug side effects. The rest of the procedures, including the transplant, can be
done on an outpatient basis. Follow-up visits for the first 3 months after the transplant
will be scheduled once or twice a week for a physical examination, blood tests and symptoms
check. Then, visits will be scheduled at 6, 12, 18, 24, 30, 36, and 48 months
post-transplant. Visits for the first 3 years will include blood tests, skin biopsies, and
bone marrow biopsies.