Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB)
Status:
Terminated
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
Summary
Blood disorders such as leukemia or lymphoma or hemoglobinopathies can benefit from receiving
an allogeneic (meaning that the cells are from a donor) stem cell transplant. Stem cells are
created in the bone marrow. They grow into different types of blood cells that the body
needs, including red blood cells, white blood cells, and platelets. In a transplant, the
body's stem cells would be killed and then replaced by stem cells from the donor. Usually,
patients are given very high doses of chemotherapy (drugs which kill cancer cells) prior to
receiving a stem cell transplant. However, patients that are older, have received several
prior treatments, or have other organ diseases are at a high risk of getting life-threatening
treatment-related side effects from high doses of chemotherapy. Over the past several years,
some doctors have begun to use lower doses of chemotherapy for preparing patients for a stem
cell transplant.
A condition that can occur after a stem cell transplant from a donor is Graft Versus Host
Disease (GVHD). It is a rare but serious disorder that can strike persons whose immune system
is suppressed and have received either a blood transfusion or a bone marrow transplant.
Symptoms may include skin rash, intestinal problems similar to inflammation of the bowel and
liver dysfunction.
This research study uses a combination of lower-dose chemotherapy agents that is slightly
different from those that have been used before.
The medicines that will be used in this study are Fludarabine, Busulfan, both chemotherapy
medicines, and Campath. Campath is a monoclonal antibody (a type of substance produced in the
laboratory that binds to cancer cells). It helps the immune system see the cancer cell as
something that needs to be destroyed.
This research study will help us learn if using Fludarabine, Busulfan and Campath prior to an
allogeneic stem cell transplant can provide treatment for blood disorders while decreasing
the incidence of side effects.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine The Methodist Hospital Research Institute The Methodist Hospital System