A Monoclonal Antibody Conditioning Regimen for Allogeneic Stem Cell Transplant in Patients With Fanconi Anemia.
| Status: | Archived |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
CD45 (YTH-24 and YTH 54) and CD52 (CamPath-1H) Monoclonal Antibody Conditioning Regimen for Allogeneic Donor Stem Cell Transplantation of Patients With Fanconi Anemia.
Patients eligible for this study have an aggressive blood disease, Fanconi Anemia (FA) that
requires an allogeneic (meaning the cells come from a donor) stem cell transplant using a
family member or nearly identical matched donor. Stem cells are cells in the bone marrow and
blood that can form a whole new blood system.
Usually, these patients are given high doses of chemotherapy before receiving a stem cell
transplant in order to keep the immune system from rejecting the donor stem cells, and to
kill any diseased cells that remain in the body. However, some patients, due to
complications with their condition, may have a high risk of acquiring possibly
life-threatening treatment-related side effects such as graft versus host disease (GVHD).
GVHD occurs when the new stem cells (graft) recognize that the body tissues of the patient
(host) are different from those of the donor. When this happens, cells in the graft may
attack the host organs, primarily the skin, the liver and the intestines. Even with the
strongest available treatments, graft rejection can occur or some diseased cells may survive
and cause relapse.
Instead of the high dose chemotherapy usually given before a transplant, this research study
uses a new pre-treatment combination of two drugs, Anti-CD45 and CAMPATH-1H. Anti-CD45 and
CAMPATH-1H are antibodies against certain types of blood cells, including FA cells.
CAMPATH-1H is particularly important because it stays active in the body for a long time
after infusion, which means it may work longer at preventing GVHD symptoms.
Before treatment begins, patients will be evaluated to confirm that they meet the
requirements of this study. Participants will need to have a central line. This is a thin
plastic catheter or tube that is placed during surgery into one of the large veins in the
chest or neck. Central lines are used to give intravenous (IV) medications (medicines that
go directly into the vein) or to take blood samples without you having to endure frequent
needle sticks.
CAMPATH-1H will be given as a daily 4-hour IV (intravenous, by vein) infusion for three
days. Anti-CD45 will be given as a daily 6-hour IV infusion over the next 4 days. There will
then be a one-day rest period before receiving the stem cell transplant.
After the transplant, participants will be followed closely. While in hospital, patients
will have a physical examination done daily. They will also have a daily urinalysis (where
some of your urine is tested to see what it contains) and blood tests done, which are
standard for anyone receiving a transplant.
To see how the Anti-CD45 is working in the body, blood will be drawn 2 hours before each
infusion of the Anti-CD45, at the end of each infusion of the CD45 and then 24 hours (1 day)
and 48 hours (2 days) after the end of the last infusion of Anti-CD45. No more than 42 mls
(8-9 teaspoonfuls) of total blood will be drawn over the course of the four Anti-CD45
infusions.
When able to leave the hospital, the patient will be followed in the outpatient clinic and
will have visits and tests which are standard (the same) for anyone who receives a
transplant.
We found this trial at
3
sites
Baylor School of Medicine Baylor College of Medicine is a health sciences university that creates...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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